Fistula

Committee 18

Fistula

Chair Dirk De Ridder (Belgium) Members Obstetrical fistula* Paul Abrams (UK) Catherine De Vries (USA) Suzy Elneil (UK) Alice Emasu (Uganda) Gloria Esegbono (UK/Nigeria) Serigne Gueye (Senegal) Rahmat Mohammad (Nigeria) Sherif Mourad (Egypt) Mulu Muleta (Ethiopia) Non-obstetrical fistula Paul Hilton (UK) Sherif Mourad (Egypt) Robert Pickard (UK) Edward Stanford (USA) Consultant Eric Rovner (USA) *The obstetrical fistula part contains the scientific summary of the ICI meeting held in Marrakech, Marocco 2010. The full text of all obstetrical fistula chapters will be published as a separate volume.

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CONTENTS GENERAL INTRODUCTION

V. DIAGNOSIS OF FISTULA 1. CLINICAL DIAGNOSIS 2. DIAGNOSIS OF GI FISTULA 3. RECOMMENDATIONS

A. Obstetrical fistula I. INTRODUCTION

VI. MANAGEMENT OF VESICO-VAGINAL FISTULA

II. WOMEN, FISTULA SURGEONS, NGOS AND GOVERNMENTS 1. 2. 3. 4.

EPIDEMIOLOGY OF VVF PREVENTION OF VVF UNMET NEEDS IN VVF MANAGEMENT OF NEW AND ESTAB LISHED VVFS 5. CLASSIFICATION OF VVF 6. MANAGEMENT OF THE COMPLICATIONS OF VVF 7. SOCIAL RE-INTEGRATION OF TREATED WOMEN

1. 2. 3. 4.

VII. MANAGEMENT OF GI FISTULA 1. 2. 3. 4.

B. Non-obstetrical fistula I. INTRODUCTION II. EPIDEMIOLOGY 1. 2. 3. 4. 5. 6.

POST-GYNAECOLOGICAL SURGERY ONCOLOGICAL FISTULA CANCER SURGERY RADIATION FISTULA CHEMOTHERAPY COMBINATION THERAPIES

III. URETERIC FISTULA

CONSERVATIVE MANAGEMENT SURGICAL MANAGEMENT POST-OPERATIVE MANAGEMENT MANAGEMENT OF RADIATION FISTULA

LITERATURE REVIEW NON-SURGICAL MANAGEMENT SURGICAL MANAGEMENT RECOMMENDATIONS

VIII. MANAGEMENT OF URETERIC FISTULA 1. 2. 3. 4.

GENERAL PRINCIPLES EVIDENCE QUALITY EVIDENCE SUMMARY RECOMMENDATIONS

IX. MANAGEMENT OF URETHRO-VAGINAL FISTULA 1. 2. 3. 4. 5. 6.

INTRODUCTION AETIOLOGY DIAGNOSIS SURGICAL REPAIR COMPLICATIONS FOLLOW UP

REFERENCES

IV. FISTULA INVOLVING THE GI TRACT

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Fistula Dirk De Ridder Obstetrical

fistula :

Paul Abrams, Catherine De Vries, Suzy Elneil, Alice Emasu,

Gloria Esegbono, Serigne Gueye, Rahmat Mohammad, Sherif Mourad Non-obstetrical fistula: Paul Hilton, Sherif Mourad, Robert Pickard, Edward Stanford Consultant Eric Rovner GENERAL INTRODUCTION In the developing world fistula are often a consequence of poor peri-natal care. The epidemiology, aetiology, diagnosis, treatment and prevention have been described in detail during the recent International Consultations on Incontinence.[1, 2] In contrast to the field of obstetrical fistula where the numbers of patients are high, the prevalence of non-obstetrical fistula seems to be much lower. The published series deal with small numbers, are usually retrospective and have a low level of evidence. The published obstetrical series show impressive numbers and demonstrate the level of skill that many of the fistula surgeons have obtained while working in difficult and isolated situations. In this consultation the main focus has been put on iatrogenic fistula in the developed world. An entirely new chapter was compiled on this subject. Despite the fact that the main focus was to write a chapter on iatrogenif fistula, in this edition the scientific summary of the International Consultation on Vesicovaginal fistula in the developing world, which was held in Marrakech, Marocco in 2010 was added to the text. Both committees are convinced that obstetric fistula surgeons in the developing world and reconstructive pelvic surgeons in the developed countries can learn a lot from each other. Combining the obstetrical and iatrogenic fistula into one chapter will facilitate interaction and exchange of knowledge and ideas in this difficult field of fistula repair.

A. Obstetrical fistula I. INTRODUCTION The First ICUD-SIU Consultation on Vesico-Vaginal Fistula was held at the SIU meeting in Marrakech, Morocco, October 13th – 16th 2010. The recommen-

dations are evidence-based, following a thorough review of the available literature and the opinion of recognised experts serving on the six committees. The individual committee reports were developed and peer-reviewed by open presentation and comment. Review of the literature showed no Level 1 evidence in that there were no randomised controlled trials. All evidence was confined to case series and observational data: Level 3 and 4 evidence. Hence, all recommendations were Grade B and C. The Scientific Committee includes the chairmen of the six committees, who refined the final recommendations. These recommendations published in 2011, will be periodically re-evaluated in the light of clinical experience, technological progress and research. These recommendations are taken from the full versions of the six Consultation chapters, from Epidemiology through to Social Reintegration. These chapters provide the full documentation of the existing scientific literature on the six topic areas.

II. WOMEN, FISTULA SURGEONS, NGOS AND GOVERNMENTS The effect on a woman, in the developing world, of having a VVF resulting from obstructed labour, is disastrous from her point of view, the family perspective and for her society. It is estimated that there are two million women, in developing countries, mainly in sub-Saharan Africa, the Indian sub-continent and South- East Asia, who have either undetected or untreated VVFs. New fistulas are probably occurring at the rate of 82,000 new cases per year, yet only 10,000 operations for fistula closure are being done annually. Hence, this leaves a huge unmet need. VVF, in itself, is bad enough, but it is also inextricably linked with high maternal mortality rate and high infant death rate. Hence the solution to fistula is similar to the solutions that will drive down the maternal mortality rate and the infant death rate. The solutions are not only medical, but also social and political. At present, women in developing countries are often dependent on donations that reach their country

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through non-governmental organisations (NGOs) and charities. The relationship between the NGOs and the fistula surgeons are critical. The fistula surgeons are the experts and those to whom fistula women turn for help. Hence, it is vital that the NGOs allow themselves to be guided by the fistula surgeons as to the priorities within their sphere of work. The vital role of the NGOs is to provide financial and logistical support. Support is also essential to allow the fistula surgeons to write up their work. This is often a considerable problem, as their commitment to the women means that their academic time is restricted. Nevertheless, the data the fistula surgeons generate is their intellectual property, and it is vital that they retain primary authorship of all published material. There are an enormous number of committed and dedicated individuals from both within the developing countries and from developed countries who have committed themselves to the cause of helping women with this dreadful condition. However, the long-term solution must see the responsibilities for women’s and children’s health passing to the governments of the individual countries. Nevertheless, in the meantime, those many dedicated individuals will continue to strive to help as many women as possible return to a life in their own community.

the delivery location. The reason for the woman not receiving help rarely differentiates between the absence of health-seeking behaviour and the lack of services. The only observational study showed no substantial difference between VVF patients and women who delivered without fistula, both in terms of their use of orthodox health care services and more traditional forms of support before childbirth. Recommendations 1. Community-based epidemiological studies using standardised and validated collection tools with acceptable sensitivity and specificity are highly recommended. 2. A validated standardised collection tool should be developed and used in national surveys to facilitate the collection and comparison of data when assessing the regional, continental and global magnitude of VVF and the distribution of fistula world-wide. 3. Prospective longitudinal community-based studies are needed to estimate the incidence of obstetric fistula. 4. Observational studies are needed, utilising advanced epidemiological analyses for: -R  isk factors (multivariate analysis controlling potential biases)

1. EPIDEMIOLOGY OF VVF

- Impacts and consequences of VVF

Epidemiological studies on obstetric fistula are inadequate. • They are mainly institutionally-based, retrospective cases series, often written from the perspective of a single fistula surgeon • The geographical coverage of epidemiological reports is uneven • However, better and more relevant information is emerging. The incidence of fistula is expressed per 1,000 deliveries and would appear to be between 0.1% rising to 1.5 per 1,000 pregnancies in rural areas. The major risk factors appear to be age at first marriage, short stature, pregnancy with a male child rather than a female child, failure to attend antenatal care, low socio-economic status, low social class, lack of employment and illiteracy. The consequences of obstetric fistula include divorce (16-92%), social isolation, worsening poverty, malnutrition, sexual dysfunction and mental illness (including anxiety/depression), insomnia, general ill health and thoughts of worthlessness and suicide. There are few detailed reports documenting these women’s obstructed labours. The time of onset of labour is rarely recorded and reports from delivery locations may disregard the fact that the woman has laboured at home for days prior to attending

- Determining health-seeking behaviour 5. Research that identifies the different profiles of women who manage to overcome the obstacles and successfully access health care, compared to those who do not, is recommended. 6. The contribution of other factors, such as ethnic background and malnutrition, needs to be researched and understood. 7. It is recommended that there is long-term follow up of patients following fistula repair to understand their ongoing quality of life and any long-term sequelae and their ongoing needs.

2. PREVENTION OF VVF VVF is a characteristic of abject poverty, a clear marker of failure of political, social and health systems to protect and promote women’s health and their rights. Prevention of VVF is ultimately linked to prevention of maternal and infant mortality and is a requirement of MDG5 of 2000. Prevention, from the medical and public health point of view, mitigates the effect of VVF in the overall burden of pain and suffering the condition imposes, not just on the patient herself, but her family and the entire community. History has shown that improvements in the functioning of local health services dramatically reduce the incidence of maternal death, infant mortality and vesico-vaginal fistula. The following areas of health system improvement and capacity building need to be considered:

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• Enhancing professionalism among health care workers to make the system work better. • Massive infrastructural developments through strengthening existing government health facilities, and advocacy, to maximise the benefits that a political environment sensitive to the needs of these women, is required. • Ensuring that facilities are properly equipped, monitored and supervised with an emphasis on quality as well as quantity of service provision. Systematic improvements are required to address the social and economic inequalities, such as the low status of women, lack of education for girls, early marriages and pregnancy, malnutrition, poverty, inadequate health and transportation infrastructure, and harmful traditional practices, such as female genital mutilation. Health and maternal care are inextricably linked to the availability of financial resources, to the individual in the community and within the country as a whole: as economic conditions improve, the risk of VVF diminishes. Another key stratagem, in preventing VVF, is the empowerment of women and their spouses, to develop birth preparedness plans, within the context of family planning. Family planning in wealthy regions is available according to the choice of the individual, whilst in other developing areas, such as China, it is actively encouraged, or even enforced. Other components of public health care, such as addressing the special nutritional needs of girl children and the requirements of improving their physical health, in order to improve their physical growth and maturity, are also very important. Education of the community is vital so that young women understand what VVF is, are made aware of the need to engage in the ante-natal care process, and plan for their delivery, including making transportation plans for use when they go into labour. Prevention strategies can be considered in public health terms as primary, secondary or tertiary:

• Primary prevention addresses many of the indirect causes which are essential the root causes of fistula. It attempts to reduce or eliminate the risk of the disease and by, amongst other actions, reducing the high levels of illiteracy among women. It also seeks to widen the cadre of care workers by involving, for instance, traditional birth attendants (TBA) • Secondary prevention attempts to limit the severity of the disease by detecting it at its earliest stages. •T  ertiary prevention aims to mitigate the effects of the existing disease, for example by effective treatment. The work of Haddon and Maine in the Haddon Matrix and Maine’s Three Delays provide documented approaches to the problems. Maine’s Three Delays: • The first delay: the decision to seek care is influenced by the socio-economic and cultural factors in that woman’s environment. These can include the need to obtain permission from a husband or male family member to seek care, or the community perception that only weak women need assistance with delivery and that strong women can manage delivery on their own. • The second delay is delayed arrival at the health facility. Once the first delay has occurred, the second delay becomes more serious. Road conditions, transportation and communication deficiencies may conspire to delay the woman’s arrival at a hospital or birthing centre. • The third delay is the delayed provision of adequate care at the facility, and may be due to lack of staff, supplies, or electricity. If the lights are out and there is no back-up generator or fuel, a caesarean section cannot be done. If there is no way to reach a doctor or medical officer because there are no telephones, or if equipment hasn’t been sterilised, then timely surgery cannot be performed. These three stages of delay disproportionately affect the world’s poor and, in particular, those women living in rural areas.

Table 1. Categories of Prevention Strategies: The Haddon Matrix

Primary Prevention

Secondary Prevention

Tertiary Prevention

Nutrition Education of girl child and engagement of TBAs Delayed marriage Training of medical staff/midwives Roads, ambulance, functioning health facilities Communication Adequate facilities, equipment and staff Electricity

Transportation Maternity waiting houses Field surveys Partographs Low gynaecological age

Treatment /repairs (surgery) Physical / social / economic rehabilitation and re-integration Media campaigns

Caesarean section (Symphysiotomy) Foley catheter drainage

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Recommendations 1. S trong community support is required to develop solidarity groups which include village volunteers working with trained, skilled and traditional birth attendants, depending on the local customs and resources. 2. The components of the three delays need to be identified and targeted in order to minimise the effect of obstructed labour. By this process there will be other benefits for maternal and child health. 3. There should be provision of adequate health facilities and birthing centres to which women move either as soon as they go into labour, or if labour is delayed. Such facilities must provide emergency obstetric care, including caesarean section. 4. National policies for maternity care should be developed for all countries whether or not VVF is a common complication of childbirth 5. Data collection by local, national and regional bodies should help to define the incidence of birth complications, and factors leading to the “3 Delays”. 6. The components of the “Three Delays” need to be identified and targeted for each community where there is a high prevalence of complications of childbirth. 7. Girls, women and communities should be educated about normal and abnormal labour, and facilities such as waiting houses should be available for pregnant women at risk for complicated deliveries. 8. Solidarity groups including local volunteers and skilled and trained traditional birth attendants should be developed for maternal care. 9. Birthing centres with the capability for caesarean section should be accessible and sufficiently affordable for women to use. 10. Funding should be made available to retain adequate trained staff for waiting houses and birthing centres. 11. Partographs should be employed to track the progress of delivery in order to identify problems and for data collection.

3. UNMET NEEDS IN VVF There is unmet need at every level of the healthcare service in those developing countries where VVF is a significant problem. These needs span from family planning through obstetric care, the availability of emergency obstetric services and the provision for dealing with maternal and infant post-partum problems. Unmet need has not clearly been defined, although the increasing gulf between the prevalence and incidence of fistula and its prevention and treatment is exceedingly worrying. In low resource countries there is a need for stable and enduring collaboration and partnerships

between governments and non-governmental organisations ( NGOs), such as, UNFPA, Engenderhealth, WHO and MSF. These partnerships will go some way to identifying unmet need and ensuring that unmet need is reduced. One of the most important aspects of the unmet needs in fistula surgery training has been the lack of standardization. In order that the recommendations below can even be partially met, there has to be a global strategy in developing training, education, and ancillary support for the surgeons and their associated teams. This will be partially met by the creation of the global competency-based fistula surgical training manual, created by the International Federation for Gynaecology and Obstetrics (FIGO) with International Society of Fistula Surgeons (ISOFS). The purpose of this manual is to enable health care providers to acquire the required knowledge, skill and professionalism to prevent fistula and provide holistic care to fistula patients that includes medical, psychosocial and surgical care. A multi-disciplinary team-based approach is encouraged in the training of each doctor and his/her team nurses, physiotherapists and other health professionals. The course is structured at three levels: standard, advanced and expert levels of fistula training. The manual is made up of several components: - Curriculum Modules Each module has an outline of the course content, that the trainee is expected to be aware of. It needs to be used in conjunction with recommended references, and in some cases with specific Performance Based Assessments (PBAs). There are 7 modules that need to be undertaken. - Logbooks of Competency These are records of the work carried out by each trainee. Each must be signed off by each trainer, who will determine if the trainee has observed a procedure, has assisted with a procedure or is able to work independently. The trainer will determine if the trainee needs further training in a particular area. - Performance Based Assessment (PBA) Each aspect of surgical training will be assessed separately and specifically. The trainees will complete each PBA to a standard, advanced or expert level and ideally need the signature of two or more trainers, from two or more training centres. It is expected that each trainee will undergo a prolonged period of fistula training at one or more centres. There are 15 PBA to be completed before a fistula surgeon would be deemed to be an expert, and will often require the full 24 months of training. However, this is a competency-based training manual and each trainee will require different lengths of time to achieve each level of expertise. This structured approach of the competency-based manual will attempt to standardise and support surgical training in fistula repair. In the process of achieving this aim, it is envisaged that there will eventually

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be an increase in the number of training centres accredited for training and eventually surgeons trained. Recommendations 1. Unmet need has to be defined in each country, and within each country, in each geographical region. 2. The unmet need in ante-natal services needs to be rectified urgently in order to minimise the number of new fistulae occurring. 3. The need for education and training has to be addressed for birth attendants, community nursing and fistula surgeons. 4. Training centres for fistula surgeons need to be identified and new ones established, according to population matrix. Training should be systematic and structured, using assessment tools such as those developed by FIGO with ISFOS. 5. Audit and research must be developed in order to ensure that quality and advances in treatment methods are ensured. 6. National strategies need to be developed to empower individual nations to take charge of the women’s and children’s services in their country.

4. MANAGEMENT OF NEW AND ESTABLISHED VVFS Management of VVF depends on whether the fistula is diagnosed within two or three months of its occurrence or whether the woman presents late with an established fistula. There is evidence that early catheter care will result in the cure of a significant minority of VVFs. Algorithm 1 (Figure 1) describes the management of women who have both early fistulas, defined as those that have occurred within 75

days of presentation, and established fistulas, that is those that are discovered more than 75 days after obstructed labour.

5. CLASSIFICATION OF VVF The Consultation believes that fistula audit research is considerably hampered by the plethora of VVF classification systems, of which we believe there are 32. The Consultation feels that the fistula system that is able to relate its classification to outcome is the classification that should be used in the next few years. The Waaldijk Classification is the only one that has been used to document sufficient numbers of patients from diagnosis to follow-up (Figure 2). Figure 2 shows the Waaldijk Classification which involves precise measurements of the distances between the external urinary meatus and the distal edge of the fistula, together with the widest diameter of the fistula. Fistulas are classified into types 1, 2 and 3. Type 3 fistulas are those fistulas other than vesico-vaginal fistulas and include recto-vaginal fistulas and uretero-vaginal fistulas. The Waaldijk Classification of Types 1 and 2 is illustrated in Figure 3 and described below. If catheter drainage fails, then fistula repair will be necessary. There are certain principles behind fistula repair: • Necrotic tissue must be removed prior to fistula repair. •F  istula repair must only be undertaken by a properly trained surgeon. • Adequate post-operative care is essential. • Proper follow-up should be arranged.

Figure 1. Algorithm to describe the management of fistula detected early (less than 75 days after obstructed labour) or later

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Table 2 indicates the type of fistula closure that should be used depending on the type of fistula. Bladder / urethra direction of closure Pubocervical fascia / urethral support Ant vagina wall closure Recommendations 1. The comprehensive use of an indwelling catheter with free urinary drainage should be instituted for all patients who have undergone either an emergency caesarean section or a traumatic vaginal delivery after obstructed labour. 2. When fistula surgery is necessary the woman must be assured of the surgeon’s competence to carry out her procedure. 3. It is recommended that further research is needed into the classification of fistula, not only to further validate the Waaldijk Classification, but also if other classifications are proposed for development. 4. There is a need to compare different surgical approaches to fistula within the context of randomized controlled trials, using the Waaldijk Classification to precisely describe the fistulas. 5. Long-term follow up of fistula patients is recommended in order to study the outcome of both conservative and surgical management and, in particular, to determine its effect on quality of life.

Figure 3. The Waaldijk Classification for VesicoVaginal Fistulas

Figure 2. The Waaldijk Classification for Fistula

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6. When reporting the outcome after fistula repair, authors should make a clear distinction between fistula closure rates and post-operative incontinence rates, specifying the time at which followup was carried out.

6. MANAGEMENT OF THE COMPLICATIONS OF VVF The complications of Vesico-vaginal fistula are many but include: • Persistence or recurrence of urinary incontinence • Persistence of lower urinary tract symptoms or occurrence of new lower urinary tract symptoms, including overactive bladder • Urinary tract infections

woman is able to have an elective caesarean section when she goes into labour. 5. In recurrent identifiable fistula make sure of the size and number and this kind of fistula is better repaired by a well experienced fistula surgeon. It is important to use tissue interposition like a Martius flap or fibrin glue. 6. With urinary tract infections or abscess formation, antibiotics must be given before and after the repair, according to culture and sensitivities. 7. Patients complaining of persistent leakage due to urgency incontinence may try antimuscarinics, botulinum toxin injection or even augmentation cystoplasty in small contracted or poorly compliant bladders. 8. Those with a shortened or disrupted urethra, before or after repair, must be treated with urethral reconstruction, autologous slings or injection of bulking agents, delivered trans or peri –urethrally.

• Upper urinary tract symptoms, including loin pain • Dyspareunia and sexual dysfunction • Infertility

9. In cases with unilateral or bilateral ureteric ligation or injury, the early diagnosis is life saving. Patients must be promptly treated by endoscopic ureteral stenting, PCN or ureteric reimplantation.

• Neurological symptoms • Psychological problems and mental illness Recommendations 1. A care programme for failed repairs with persisting incontinence after a successful repair, needs to be in place. 2. It is recommended that surgical treatment of post-operative stress incontinence should only be considered six months after fistula repair.

10. Patients complaining of contracted vagina and dysparunea with sexual dysfunction may use local estrogen, vaginal dilatation or may require the surgical creation of vaginal flaps to augment the vagina.

3. Autologous material should be used when a graft or sling is required and there is no place for synthetic sling material.

11. Patients who develop dropped foot may respond to physiotherapy or require tibialis tendon transfer. Women with neurogenic OAB may benefit from detrusor muscle botulinum injections if antimuscarinic drugs fail.

4. In order to prevent new fistulas in women who become pregnant after a fistula repair, waiting homes should be provided to ensure that each

12. Psychological trauma, social isolation and depression is best treated by counselling and psychological rehabilitation.

Table 2. Surgical Techniques for the Closure of Type l and Type ll VVFs

Bladder / urethra direction of closure

Pubocervical fascia / urethral support

Ant vagina wall closure

Type l

Any according to common sense

No special measure

Approximate vag edges

Type llAa

Transverse

Transverse adaptation

Type llAb

Circumferential end-to-end

Transverse repair (+ fixation) / sling Refixation / sling

Transverse adaptation

Type llBa

Longitudinal (+ transverse) urethra tissue Longitudinal + circumferential non-urethra tissue

Fixation / sling

Flap

Refixation / sling

Flap

Type llBb

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Table 3. Social Re-integration Matrix ELEMENT Physical Improved physical health

LEVEL Facility

Community

Early detection Rehabilitation Skilled surgeon Timely repair

Outreach

Designated space

Follow up

Political Allocate funds for treatment

Health education

Psychological Improved mental health

Psychosocial therapy e.g. stigmatisation

Advocacy and sensitisation Follow up

Socio-economic Increased social connection

Vocational skill training Linkage with Existing programmes

Microcredit or finance Follow up

7.  SOCIAL RE-INTEGRATION OF TREATED WOMEN Social integration is defined as appropriate interventions that help women with obstetric fistula overcome physical, psychological and socio-economic challenges, freely identified by themselves, in order to enhance their return to the communities and social networks of their choosing, such that the risk of them presenting with another fistula is minimized. The aim of social re-integration is to break the fistula recurrence/occurrence cycle in which the woman’s physical state is inextricably connected to her mental state and her socio-economic situation. Social re-integration should be seen as happening from the time the leaking of urine becomes manifest, and every subsequent intervention should have the re-integration of the woman, back into her community, as the primary goal. So, social re-integration is the responsibility of everyone who cares for the woman. Social re-integration can be usefully looked at within a matrix, as shown in Table 3 where the three elements of physical, psychological and socio-economic status are looked at in terms of the facility for treating the patient within her community and the political environment. Recommendations 1. Social re-integration is important for all women with obstetric fistula. It is the process by which women are helped to overcome physical, psychological and socioeconomic challenges, freely identifiedby themselves, in order to enhance their level of social functioning in communities and social networks of their choosing, so that the risk of will presenting with another fistula is minimised. 2. Social re-integration should be used for all women. However this series of interventions can be performed by any trained care worker, providing it focuses on making the woman part of her social fabric again, and commences from the time leaking of urine becomes manifest.

Raise awareness on issues of counselling Link u p with ongoing national poverty alleviation programmes

3. S ocial re-integration should be designed to break the fistula recurrence cycle in which the woman’s physical state is inextricably connected to her mental state and her socio-economic situation. 4. Early successful surgical repair or catheter management is highly recommended and is likely to be the only thing needed for social re-integration. Surgery should be performed as soon as possible by a skilled surgeon, and preferably within 3 months of developing the fistula, as this is likely to limit the length of time the woman is seen as abnormal by her family or community and thus perceived as an outcast. 5. S  ocial re-integration should start in a designated space where women can recuperate, perhaps within the repair facility or nearby, rather than going home and encountering the risk of behaviours which may make it likely that a recurrence of fistula occurs, due to an exacerbating physical event such as early sexual intercourse or heavy work. Also, peer counselling is more likely to be available in this space. 6.Surgeons and other care workers should consider social re-integration as not just a social tool but also as a means of ensuring that adequate follow-up of the postsurgical improvement in quality of life is done and reported on. At the least, there should be a review of individually defined success of surgery and surgical outcomes, including continence and return to fertility and/or sexual life, as desired by the woman. 7. A  ppropriate counselling messages about the risk factors and causes associated with fistula should be targeted at family members (including husbands) and the community, as this can help to overcome the stigma, discrimination and misconceptions surrounding the condition and enhance her community inclusion. It is then an opportunity to make changes so that

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the woman does not present with another fistula in the future.

should have a choice as to whether they wish to be involved in such advocacy activities.

8. C  ounselling should be seen as an opportunity for health providers to understand the socioeconomic, psychological and physical experiences that are faced by girls and women living with fistula, before and after surgery, so that they may give meaningful help. This will also help to generate knowledge on social re-integration processes and will help in the planning of a broader range of outcomes for women living with fistula.

15. S  ocial re-integration programmes should be monitored and evaluated in order to collect correlates of success and failure and to help understand socio-cultural backgrounds, so that a context specific approach can be used to design and deliver effective, feasible reintegration programmes.

9. S  ocial re-integration should include assistance with education and life skills, and encouragement of private initiatives through vocational skills development and microcredit support. If this is freely chosen, it will not keep a woman away from her community unduly, and will help her regain or improve her previous economic status and enhance her self-sufficiency and community inclusion.

Scientific Committees for 1st Consultation on VVF (Chairpersons in bold)

10. S  ocial re-integration should include vocational skills training with the aim of providing women with alternative ways to generate income, without jeopardising their recuperation, by teaching them a trade which is economically viable within their community. 11. Institutional re-integration services should be incorporated into existing community activities or programmes directed to empower women (e.g. education, skills training, income generation, self-esteem). 12. Re-integration programmes should develop criteria to determine where support with socioeconomic interventions should be given, as funds may be limited and fistula consequences can vary dramatically by country and region. They should also be careful not to increase the burden of stigma and therefore inadvertently impede re-integration. Of particular concern should be women who are still incontinent, those who are deemed incurable, those who have no children and those who have lived with fistula for a long period of time. 13. Social re-integration programmes need to consider the potential ethical dilemmas in re-integration such as providing targeted financial support or high value goods to women with fistula in poor communities, other than as part of a community approach. 14. Social re-integration should seek to involve women who have been successfully re-integrated into their communities. These women can be termed motivational mobilisers and can contribute to community mobilisation movements for safe motherhood, fistula case mapping and referrals for treatment. Women

Below is set out the committee structure for the Consultation, within whose chapters full details of each committee’s work can be found.

1. Epidemiology

AHMED, aifuddin ARROWSMITH, Steve MULETA, Mulu KISERUD,Torvid

(USA) (USA) (Ethiopia) (Norway)

2. Prevention Strategy

BANGSER, Maggy (Tanzania) COCHRAN, Seth (USA) EMASU, Alice (Uganda) –Co-chair LENGMANG, Sunday (Nigeria) L  USI, Lyn (Congo) KIRYA, Fred (Uganda) DE VRIES, Catherine (USA)

3. UnmetNeeds

ELNEIL, Suzy GAME, Xavier PATEL, Naren RUSHWAN, Hamid RUMINJO,Joseph

4. Surgery for Fistula

ABUBAKAR, Kabiru RAASSEN, Tom DE RIDDER, Dirk WAALDIJK, Kees

(UK) (France) (UK) (UK) (USA) (Nigeria) (Kenya) (Belgium) (Nigeria)

5. Complex Fistulae and the Complications after Fistula Surgery HILTON, Paul MOURAD, Sherif MWANJE HARUNA, Moses SHAKER, Hassan VASAN, Sirini

6. Social Integration

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(UK) (Egypt) (Uganda) (Egypt) (India)

AKHTER, Sayeba (Bangladesh) BROWNING, Andrew (Ethiopia) ESEGBONA, Gloria (UK/Nigeria) ISAH, Adamu (Nigeria) KAONGA, Taonga (Malawi) MOHAMMAD, Rahmat (Nigeria) – Co-chair

B. Non-obstetrical fistula I. INTRODUCTION Iatrogenic urogenital fistulae are known complications of pelvic surgery and oncological treatments such as radiotherapy. For example a high quality population-based case-control study from Sweden found that the risk of urogenital fistula was 25 times higher amongst women undergoing hysterectomy (n=180,000) compared to an age matched control population (n=525,826) without hysterectomy. The risk appeared to be highest for laparoscopic hysterectomy and lowest for sub-total hysterectomy but absolute numbers were small with a number needed to harm of 5,700.[3] This section is based on electronic searches of Medline, EMBASE (from 1980 to November 2011), the Cochrane Database of Systematic Reviews, Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Database of Health Technology Assessments, and Database of NHS Economic Evaluations, and the NICE website (all accessed November 2011); references included in identified systematic and non-systematic reviews were evaluated separately. Hand searching of recent (Jan-December 2011) issues of major American, European and British journals in urology, gynaecology and urogynaecology was undertaken, to capture recent publications not yet included in the online databases. ICS, IUGA, AUA, AUGS and SGS conference proceedings for 2011 were also reviewed. It was assumed that studies and trials presented earlier than this would be in press if they were of sufficient quality and maturity to justify inclusion; hence older abstracts have not been considered.Papers offering any relevant data were considered. This included systematic reviews, randomised and quasirandomised trials, non-randomised cohort studies, case controlled studies, longitudinal studies and case series or reports. Those papers considered for inclusion were assessed for quality where relevant, in terms of sequence generation, allocation concealment, blinding, and handling of incomplete data, selective reporting and freedom from other biases. An evidence level [EL] was then assigned to all included studies according to the ICUD modified version of the Oxford Centre for Evidence-based Medicine system. [4) Where quality was considered to be poor – as in most of the studies included in these sections – the evidence level was reduced accordingly. Recommendations (graded A-D) were made on the basis of consistent or ‘majority evidence’ identified.[4]

II. EPIDEMIOLOGY 1. POST-GYNAECOLOGICAL SURGERY Fistulae involving the lower urinary tract can occur following any surgical procedure or traumatic event

to the female reproductive tract, bladder, or rectum. In developing countries, the most common aetiology of fistulae involving the lower urinary tract is clearly obstetric trauma. [5] In most developed countries in which antenatal and intrapartum care is more readily available, obstetrical fistulae are relatively rare and the majority of fistulae are related togynaecological surgery. The ratio of obstetric to gynaecological fistula appears to be consistent at about 10:90 in developed countries. [6] In some developing countries, as gynaecological procedures to treat benign and malignant conditions of the female reproductive tract are more commonly performed, the rate of iatrogenic fistulae is increasing (e.g. Pakistan). [7] The types of fistulae associated with gynaecological procedures may include communication between any reproductive organ (uterus, cervix, Fallopian tube, vagina), intestinal tract (colon, rectum), genitourinary organ (bladder, ureter, urethra), and cutaneous system (abdominal wall, perineum). The combinations, locations, and severity of gynaecological fistulae vary with each patient. In general, vesicovaginal fistulae (VVF) are the most common type. The most common causes of VVF as a consequence of surgery, in developed countries isan injury injury to the urinary tract during hysterectomy for benign conditions (60-75%), followed by hysterectomy for malignant conditions (30%), caesarean section (6%), and obstetric injuries (1%). [8][9] At the ZekaiTahirBurakcentre in Turkey 25,998 gynaecologic and obstetric operations were performed over a 3-year period. The bladder was the most frequently injured organ. Urinary tract injury rates were reported to be 0.49% for the bladder and 0.24% for the ureter in gynaecological operations, and 0.18% for the bladder and 0.01% for the ureter in obstetric operations.[10] Overall, the risk of pelvic organ fistula following hysterectomy has been reported to be between 0.1 and 4%. [11]. It is important to recognize that most urinary tract injuries do not result in a fistula. The prevalence of genitourinary injury and fistulae vary slightly from centre to centre. In one US retrospective study from the Mayo clinic, gynaecologic surgery was responsible for 82% of the fistulas, obstetric procedures for 8%, and various forms of irradiation for 6%, and trauma or fulguration for 4%. The majority of fistulae followed treatment for benign conditions. [12] The relative proportions of the types of urinary fistula have changed with urethral fistulae having increased from 6 to 13%, while ureteral, bladder and/ or urethral fistulae having dropped from 20 to 16 and 11 to 7%. [2] Given the various indications for, and types of hysterectomies, it is important to have an understanding of the type of hysterectomy since genitourinary or colonic fistula is reported with all of these procedures. The overall incidence of hysterectomy complications is estimated to be 95%. Depending upon availability, radiologic studies (cystography, urography, intravenous urography, and CT urography) may be useful. Ultrasonography and colour Doppler have been used by some, although their use

in routine practice remains to be established. [108][109] Urine may extravasate externally or internally. Creatinine levels in the urinte are higher than serum levels. Therefore, in the setting of a suspected fisula, testing the creatinine level in either the extravasated fluid or the accumulated ascites and comparing this value to the the serum creatinine levels will confirm urinary leakage but not the location of the fistula. Likewise, testing potassium levels will show higher levels compared to serum levels. [110] b) Imaging An unstructured review by Narayanan et al. suggested that magnetic resonance imaging, particular with T2 weighting, provided optimal diagnostic information regardingfistula associated with pelvic malignancy, with contrast-enhanced CT with late excretory phase an acceptable alternative.[111] These newer modalities were considered to be superior to other X-ray contrast techniques and ultrasound.

2. DIAGNOSIS OF GI FISTULA Pneumaturia, dysuria and/or recurrent UTI’s are symptoms of a colovesical fistula but may be due to other causes as well.Accepting the limitations of small case series in this regard, a number of studies have investigated the value of a range of investigative techniques in the detection and evaluation of enterovesical or colovesical fistulae.[90, 92, 93, 97, 112-116]Since in each study the authors have presented only results on patients known to have fistulae, sensitivity (true positive/true positive + false negative) may be estimated, however, specificity (true negative/true negative + false positive), positive predictive value, (true positive/true positive + false positive) and negative predictive value (true negative/true negative + false negative) cannot (see Table 3). No test was shown to have consistent reliability; excluding those investigations for which only a single report was identified, CT (53%), cystoscopy (48%), and in the case of colovesical fistula, barium enema (38%) were perhaps the most useful; intravenous urography and sigmoidoscopy or colonoscopy appear to have limited utility in the diagnosis of GI fistula.

Table 2. Data from studies examining the reliability of intra-operative cystoscopy in detecting ureteric injury

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3. RECOMMENDATIONS CT and cystoscopy appear more consistent in the C confirmation and location of possible intestino-vesical fistulae, than other investigations

Table 3: Data from studies examining the sensitivity of various investigations in the diagnosis of intestino-vesical fistulae.

Level 3 evidence indicates that the routine use of C cystoscopy with dye testing at gynaecological surgery has high sensitivity, specificity and negative predictive value in the detection of ureteric injury, although false positive tests do occur. The clinical and cost-effectiveness of routine cystoscopy remains to be established

VI. MANAGEMENT OF VESICO-VAGINAL FISTULA The literature relating to surgical fistula is extensive, but of limited quality. 356 papers of possible relevance were identified, of which only 173 contained any relevant material. Three systematic reviews were identified (albeit one only as a protocol),[117-119] although none contained information of direct relevance. Six randomised trials were identified including one on causation,[120] one on prevention of urinary tract injury at surgery,[121] two on antibiotic prophylaxis at the time of reparative surgery,[122, 123], and two on surgical techniques applied to obstetric fistulae.[124, 125] There was also one quasi-randomised study of relevance.[126] Four non-randomised cohort studies,[127-130] and one cost-effectiveness study,[131] were also identified. All other identified material comprised case series [99] and individual case reports or procedure descriptions [52], and represent level 3or 4 evidence. Three examples of duplicate publication were identified.

1. CONSERVATIVE MANAGEMENT a) Immediate management by catheterisation or defunctionalizing Before epithelialisation is complete an abnormal communication between viscera will tend to close spontaneously, provided that the natural outflow is unobstructed. Normal continence mechanisms, however, involve the physiological contraction and intermittent relaxation of urethral and anal sphincters. As a result, although completely spontaneous closure of genital tract fistulae does occur, it is the exception rather than the rule. Bypassing the sphincter mechanisms, or diverting flow around the fistula, for example by urinary catheterisation, percutaneous nephrostomy or defunctionalizing colostomy, may however encourage closure. Bazi reported a non-systematic review of papers including information on the spontaneous fistula closure of vesicovaginal fistulae; whilst the data quality of all was poor, he identified 30 studies from which 12 could be included; these included cases that were almost exclusively of surgical aetiology; it should be noted that in 9 of these 12 studies the sample size was less than 5 patients.[132] Few studies described catheter drainage in large fistulae, although it seemed that

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Table 4. Data from studies including rates of spontaneous closure of surgical vesico-vaginal fistulae. n.b. table includes studies considered by Bazi,(132) but only those of known surgical aetiology.

those of less than 1cm diameter were most likely to heal spontaneously. The time between the insult and institution of drainage in cases of non-surgical closure varied widely, although in most cases this was less than 3 weeks. Similarly, the duration of catheterisation prior to the initiation of conservative treatment was deemed to have been unsuccessful varied considerably, making true estimates of the effectiveness of this approach impossible; generally this varied between 10 days and 3 months.[132] Reported success rates varied between 0% and 100% (although 5 series had a sample size of 1!), although in several series it was difficult to determine how many women had attempted conservative management.[132] In large series of obstetric fistulae where a consistent approach to conservative management has been applied, spontaneous healing has been reported in up to 28% of cases. [133-135] In one series of urogenital fistulae of varying aetiologies, spontaneous closure was seen in 19/238 or 8.0% of surgical cases, 4/38 or 10.5% of obstetric cases, 1/36 or 2.8% of miscellaneous (largely traumatic cases) and 0/34 or 0.0% of radiotherapy related cases.[17] It is likely that in this, and many other reported series, data are an underestimate of the value of this approach to management,[17] nevertheless, combining available data (see Table 4) gives an overall spontaneous closure rate from 348 surgical fistulae treated by initial catheterisation of 13% ± 23%.[8, 17, 21, 136-145]. Patients with ongoing, continuous vaginal leakage despite a functioning indwelling catheter are unlikely to have resolution of the VVF without additional measures such as surgery. Such patients

should be spared prolonged catheter drainage and proceed with more definitive repair as soon as medically appropriate.Small epithelialized fistulas may benefit from minimally invasive cystoscopic electrocoagulation of the fistula tract, followed by prolonged catheter drainage. In patients with fistulae less than 3.5mm in diameter, 11/15 had successful fistula tract ablation with cauterization and catheter drainage in a study by Stovsky et al.[146] In general, conservative measures are successful in small fistulas only, usually less than 2-3mm in diameter. b) Pharmacotherapies to assist fistula closure Several case reports describe successful fistula closure following the induction of amenorrhoea by oestrogen, oestrogen/progesterone combinations, or luteinising hormone releasing hormone analogues,[147] in the management of vesicovaginal,[148] and more frequently, uretero- or vesicouterine fistula following caesarean section.[149-153] The overall closure rate in these studies is 88%±16%. Spontaneous closure of vesico-uterine fistula has also been reported on a number of occasions,[150, 154] with a rate of 41/786 or 5% calculated in one review.[150] Whilst comparison across studies is obviously highly problematic (especially where many are single case reports, with success rates of 0% or 100%), it seems highly likely that the rate of closure following hormone treatment [14/16] is significantly higher than that of spontaneous closure [41/786] (p 6 months) surgical repair when required.[301] Surgery should again adhere to the standard principles of tissue repair and safe anastomosis. Functional and anatomical imaging should be used to follow up patients after repair to guard against late deterioration in function of the affected renal unit. These general aspects of care of patients with trauma to the upper tract and subsequent fistula formation are covered in standard textbooks of urology and guideline documents. [300, 301] This review will concentrate on developments in the past six years.

2. EVIDENCE QUALITY

There is evidence that infliximab is efficacious in the treatment of external fistulae, but only very limited low level evidence of efficacy in urinary B/D fistulae in association with Crohn’s disease A one-stage approach to surgery for intestinovesical fistulae is appropriate in many cases, but should be limited to those patients whose nutritional state is good, and where there is no evidence of additional intra-abdominal pathology (e.g. severe inflammation, radiation injury, advanced malignancy, intestinal obstruction) or major co-morbidity A laparoscopic approach to one-stage management has been shown to be feasible, although there is no high level evidence to allow comparison of outcomes with open surgery

A total of 127 abstracts were screened which were categorised as being not relevant [26], cases reports without useful information [63] and for possible inclusion [38]. After review of full text, 27 were selected for the review and 11 rejected due to duplicate information (n=7) and no relevance (n=4). Four further possible papers were identified from the reference lists of included articles of which two were included in the review. The selected papers [29] included one poor quality randomised trial [302], one poor quality quasi-randomised trial [303], one high-quality population case control study[3], one registry study[76], one systematic review[304], one cost analysis[305], 14 cases series, 8 case reports, and one unstructured review.

B

D

3. EVIDENCE SUMMARY

VIII. MANAGEMENT OF URETERIC FISTULA

a) Management of Specific Fistula 1. Urinary

1. GENERAL PRINCIPLES The relevant clinical principles are related to prevention, diagnosis, management, and after care. [299] Patients at higher risk of ureteric injury such as those undergoing complicated childbirth, radical or repeated pelvic surgery, or surgery following pelvic radiotherapy require experienced surgeons who can identify and protect the ureter and its blood supply to prevent injury and also recognise injury promptly when it occurs. Immediate repair of any intraoperative injury should be performed observing the principles of debridement, adequate blood supply and tension free anastomosis with internal drainage using stents.[300] Delayed presentation of upper tract injury should be suspected in patients whose recovery after relevant abdominal or pelvic surgery is slower than expected, if there is any fluid leak, and if there is any unexpected dilatation of the pelvi-calyceal system. Fluid should be sent for creatinine determination to differentiate serous from urinary leak. Repair of such cases should be undertaken by an experienced team and may consist of conservative management with internal or external drainage, endoluminal management using nephros-

leak after renal preservation surgery

A large case series identified urinary fistula, defined as urinary drainage from a drain site more than 14 days post-operatively, in 4% [45/1118] of patients undergoing partial nephrectomy.[306] This was associated with larger tumours, higher blood loss, and longer ischemia time, but not the mode of surgery (laparoscopic versus open). The majority resolved without intervention but 30% required ureteric stent insertion or percutaneous drainage. A poor quality quasi-randomised study involving 16 patients with persistent leakage after pelvi-calyceal surgery despite stenting found that use of intranasal desmopressin 40 µg daily resulted in a shorter time to resolution of leak compared to control.[303] 2. Urinary

leak after renal transplantation

A case series from Brazil observed a fistula rate of 2.9% [31/1046]presenting at a mean of 28 [1-131] days following transplantation predominantly due to distal ureteric necrosis and with most cases requiring open repair.[307] Fistula occurred more commonly in patients with diabetes and was associated with lower graft survival and two deaths from sepsis. A case se-

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ries from China observed fistula development in 3.5% [43/1223] of patients presenting at a mean (range) of 6 [3-20] days following transplantation again primarily due to necrosis of the distal transplanted ureter. [308] Open intervention with re-implantation of the ureter into the bladder or native ureter was required in 34 patients, with one other patient requiring transplant nephrectomy. The occurrence of a fistula did not appear to prejudice graft or patient survival. Initial implantation of the transplant ureter into the native ureter appeared to result in a lower rate of fistula. A further case series form Serbia found a fistula rate following renal transplantation of 2.2% [5/224] and all required open repair.[309]

past surgical history particularly pelvic cancer surgery (54%) and arterial surgery with graft insertion (31%), and 61% had a ureteric stent in situ. The great majority affected the iliac segment and pre-operative imaging was not always diagnostic. A total of 18 (13%) patients died as a result of the fistula. Many vascular and urologic interventions were used either alone or in combination. Later cases suggested that endovascular repair of the arterial defect gave the best results with lower mortality. Another, more recent case series of 20 patients also showed a high mortality of 10 – 20% but did not find any difference in outcome between open or endovascular graft insertion techniques.[313]

3. Uro-enteral

5. Ureterovaginal

fistula following percutaneous re -

nal surgery

Case reports of ureterocolic fistulae occurring after renal cryotherapy, and gunshot trauma all resolved with insertion of ureteric stent.[310, 311] This is in line with previous accounts of this complication following percutaneous nephrolithotomy.[312] 4. Uretero-arterial

fistula

A systematic literature review found reports of 139 cases of uretero-arterial fistula published between 1899 and 2008.[304] All patients presented with haematuria with 25% also having other urinary symptoms or back pain. Virtually all cases had a relevant

fistula

Ureterovaginal fistula occurring in the early postoperative phase predominantly after hysterectomy is the most frequent presentation to urologists of upper urinary tract fistula. A randomised study involving 3,141 women undergoing open or laparoscopic gynaecological surgery lasting > 30 min found that the incidence of ureteric injury after prophylactic insertion of ureteric stents (1.2 % [19/1583]) was similar to control (1.1% (17/1558]).[302] A previous cost analysis from the United States perspective suggested stenting was only worthwhile if the risk of injury was > 3.2%.[305] If injury does occur, many cases, even those with bilateral injury, can be managed by endoscopic techniques. [314](Figure 9)

Figure 9. Conservative management of bilateral lower ureteric injury. Retrograde ureterogram showing successful cannulation of left ureter by guide wire and successful placement of right ureteric stent.

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The use of ureteric stenting in patients with ureterovaginal fistulae was reported in 11 studies, including 126 patients in total;[315-325] this resulted in closure in 63 cases altogether. Success rates were between 6% and 100%, although the overall closure rate across all series is calculated at 50% ± 18% (see Table 9). Where retrograde stenting proves impossible, percutaneous nephrostomy and antegrade stenting might be considered if there is some degree of pelvicalyceal dilatation. Ureteroscopy may also be helpful,[320, 324] and a technique for combined antegrade and retrograde ureteroscopic cannulation has been reported.[317] In one report all cases of uretero-vaginal fistula were managed by temporary diversion using a percutaneous nephrostomy followed by delayed repair 4-6 weeks later,[156] and a similar approach was taken in the management of one uretero-uterine fistula.[326] If endoluminal techniques fail or result in secondary stricture, the abdominal approach to repair is standard and may require end-to-end anastomosis, re-implantation into the bladder using psoas hitch or Boari flap, or replacement with bowel segments with or without reconfiguration. Recent case series suggest that this standard surgery can be performed safely and with reasonable operative times using laparoscopic or robotic techniques if the relevant skills and facilities are available.[327-329] A recent case report has sug-

gested that open repair through the vagina is possible if abdominal access is problematic.[330] 6. Ureteric

fistula associated the terminal phase

of pelvic malignancy

Urinary leakage is very distressing for people dying of advanced pelvic malignancy but palliation by open diversion may be associated with a high rate of complications. Recent case series have described the technique of occlusion of the distal ureter with coils or other devices using an antegrade approach combined with chronic urinary diversion using nephrostomy tubes.[331-333]Natarajan et al reported successful management of five patients with two requiring repeat embolization but all achieving good palliation until death without adverse effects.[331]Shindel et al reported on 29 patients with bothersome urinary fistula despite chronic nephrostomy drainage, and poor performance status.[332] In all cases palliation of the urinary leakage was achieved. The majority of patients [23/29] died of their underlying cancer at a mean of 8 months after the procedure. Three patients with benign disease subsequently underwent definitive surgical diversion with the remaining 2 lost to follow up. Coil migration was seen in one patient without serious consequence and there were no other complications specific to the embolization. Kim et al used the technique to temporally palliate five women with ureterovaginal fistula prior to delayed definitive repair.[333]

Table 9: Data from studies including rates of closure of uretero-vaginal fistulae with ureteric stenting.

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The algorithm for uretero-vaginal fistula can be found in Figure 10

industrialized countries urethrovaginal fistula in adults mostly have an iatrogenic aetiology. (See Table 10)

Evidence table

In feminizing genital reconstructions in children with ambiguous genitalia and surgical repairs of cloacal malformations, urethrovaginal fistula can occur as early or late complications. [334][335, 336][337, 338] Also in transsexual adults undergoing female to male reconstruction, urethrovaginal fistulae have been reported. [339]

Prophylactic ureteric stent insertion does not reduce risk of ureteric injury during gynaecological surgery The use of desmopressin may hasten resolution of urinary leak after pelvi-calyceal surgery Uretero-arterial fistula is associated with a high mortality rate Antegrade endoluminal distal ureteric occlusion combined with nephrostomy tube diversion often palliates urinary leakage due to malignant fistula in the terminal phase

In the surgical treatment of stress incontinence in women with bulking agents [340, 341] or synthetic slings several cases of urethrovaginal fistula have been reported.[342-345] [119] (see Figure 11) Even conservative treatment of prolapse with pessaries can lead to the formation of fistula, if these pessaries are neglected for an extended period of time, although fistula formation after only 2 weeks of pessary use has been described.[18, 346](see Figure 12).

4. RECOMMENDATIONS

Surgeons undertaking complex pelvic surgery should be competent at identifying, preserving and repairing the ureter Ureteric stents are not required as prophylaxis against injury during routine gynaecological surgery, while their role in more extensive surgery remains to be established

Trauma – including inappropriate catheterisationand foreign bodies are obvious causes of fistula. [347-353]

Ureteric injury or fistula may be suspected in patients following pelvic surgery if a fluid leak or pelvi-calyceal dilatation occurs postoperatively

Urethral diverticula and their surgical repair may also lead to urethrovaginal fistula.[354-356]

Uretero-arterial fistula may be suspected in patients presenting with haematuria with a history of relevant pelvic surgery and indwelling ureteric stent

Urethrovaginal fistula have also been described in some Behçet patients with vasculitis and local necrosis of the urethrovaginal septum. [357, 358]

Elevated levels of creatinine in drainage fluid following pelvic surgery are suggestive of a urinary tract injury Most upper urinary tract fistula should be initially managed by conservative or endoluminal techniques where such expertise and facilities exist

Irradiation complications can also result in the formation of urethrovaginal fistula.[359]

3. DIAGNOSIS Clinical vaginal examination is often sufficient to diagnose the presence of an urethrovaginal fistula. Urethroscopy and cystoscopy can be performed to assess the extent and location of the fistula. In cases of difficult diagnosis, voiding cystourethrography (VCUG) or ultrasound can be useful. [360] Double balloon urethrography is the classic examination to show urethral diverticulum and urethrovaginal fistula, but 3D MRI or CT scan is becoming utilized more widely.. [361-363]

Persistent ureterovaginal fistula should be repaired by an abdominal approach using open, laparoscopic or robotic techniques according to availability and competence For patients with ureteric fistula associated with advanced pelvic cancer and poor performance status, palliation by nephrostomy tudediversion and endoluminal distal ureteric occlusion is an option

4. SURGICAL REPAIR

IX. MANAGEMENT OF URETHRO-VAGINAL FISTULA Urethrovaginal fistulas are a rather rare complication of some surgical and medical conditions or treatments. Most of the literature consists of small retrospective series or case reports. There are no randomized prospective trials.

Several techniques for urethrovaginal fistula closure have been described. A vaginal approach is mostly used. Surgical correction intends to create a continent urethra that permits volitional, painless, and unobstructed passage of urine. Depending on the size, localisation and aetiology of the fistula and the amount of tissue loss urethral reconstruction techniques may be necessary to restore the urethra and to achieve post-operative continence. [347]

2. AETIOLOGY

a) Vaginal approach

Excluding obstetric aetiologies,In the developing world, urethrovaginal fistula may occur as a result of obstructed labor with or without associated VVF. In

Goodwin described in his series that a vaginal approach yielded a success rate of 70% at first attempt and 92% at second attempt, but that an abdominal

1. INTRODUCTION

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Table 10: Etiology of urethrovaginal fistula

Traumatic

Iatrogenic

Medical

Direct trauma

Bulking agents

Beçhet’s disease

Foreign body

Sling surgery Urethral diverticula repair Catheterisation Irradiation

Figure 10. Algorithm for uretero-vaginal fistula

Figure 11. Urethro-vaginal fistula following midurethral tape procedure for SUI.

Figure 12. Fistula in anterior vaginal fornix following use of shelf pessary for utero-vaginal prolapse.

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approach only leads to a successful closure in 58% of cases. A vaginal approach required less operating time, had less blood loss and a shorter hospitalisation time.[364] Most authors describe surgical principles that are identical to those of vesicovaginal fistula repair: identifying the fistula, creation of a dissection plane between vaginal wall and urethra, watertight closure of urethral wall, eventual interposition of tissue, and closure of the vaginal wall. Primary closure rates of 53%-95.4% have been described (see Table 11). Pushkar et al. described a series of 71 women, treated for urethrovaginal fistula. 90.1% of fistula were closed at the first vaginal intervention. Additionally 7.4% were closed during a second vaginal intervention. Despite successful closure, stress incontinence developed in 52%. The stress incontinent patients were treated with synthetic or autologous slings and nearly 60% became dry and an additional 32% improved. Urethral obstruction occurred in 5.6% and was managed by urethral dilation ororurethrotomy.[365] Advancement flaps of vaginal wall can be used to cover the urethral suture line. In some cases more advanced methods are used to close or to protect the urethral closure. In cases of difficult dissection and visualisation, urethral sectioning has been advocated. [366] This technique is also being used in the repair of complex urethral diverticula.[367] Fistulae that are located in the distal third of the urethra may also be marsupialized without compromising the continence mechanism.[368] Distal urethrovaginal fistula may be entirely without symptoms, and in such cases, repair is not mandated. Blaivas advocates that vaginal flaps are usually the best option in dealing with urethral reconstruction, next to the possibility of offering anterior or posterior bladder flaps. Options for vaginal repair of fistula include primary closure, peninsula flaps, bilateral labial pedicle flaps, and labial island flaps. Outcomes are optimised by using exacting surgical principles during repair and careful postoperative management by an experienced reconstructive surgeon. [347]

1. Labial and vaginal flaps and neourethra The simplest flap is a vaginal advancement flap. [369] Labial tissue can be harvested as a pedicled skin flap. This labial skin can be used as a patch to cover the urethral defect, but can also be used to create a tubular neo-urethra. [370, 371] The construction of a neo-urethra has mostly been described in traumatic aetiologies. In some cases a transpubic approach has been used. [372] The numbers of patients reported are small and there are no data on the long-term outcome of fistula closure and continence rates. The underlying bulbocavernosus tissue can be incorporated in the pedicled flap and probably offers a better vascularisation and more bulking to the repair. This could allow a safer placement of a sling afterwards, in those cases where bothersome stress incontinence would occur postoperatively. [373, 374] 2. Martius flap While in obstetrical fistula repair, it was not found to have any benefit in a large retrospective study in 440 women, the labial bulbocavernosus muscle / fat flap by Martius is still considered by some to be an important adjunctive measure in the treatment of genitourinary fistula where additional bulking with well vascularised tissue is needed. [375] Rangnekar et al. report on 12 patients with urethrovaginal fistula, of whom 8 were treated with a Martius flap and 4 with a conventional repair. Only one out of the 8 had a fistula recurrence, while 3out of 4 of the conventional repairs broke down; it should be noted however that these cases were not randomised between surgical techniques.[376] Punekar et al. described 15 patients with complex and recurrent fistula, using the skin island flap modification with excellent results.[377]Radopoulus published a small series of 5 recurrent and complex urethrovaginal fistulas that all healed using a Martius flap.[378]The series of non-obstetrical aetiology are small and all of them are retrospective. There are no prospective data, nor randomized studies.[379, 380] The indications for Martius flap in the repair of all types of fistula remain unclear.

Table 11: Closure rates of urethrovaginal fistula Author

N patients

Success at first surgery

Success at second surgery

Blaivas[347]

24

79%

Goodwin[364]

24

70%

92%

Lee [12]

50

92%

100%

Keetel[401]

24

87.5%

Pushkar[365]

71

90.1%

Benchekroun[402]

186

53%

98.6%

52% incontinent Mostly obstetrical

Henriksson[403]

6

67%

100%

Kumar[79]

43

95.4%

100%

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3. Rectus muscle flap Rectus abdominis muscle flaps have been described by some authors. [381, 382]Transvaginal urethrovaginalfistula closure was performed followed by a pedicled rectus abdominis muscle flap interposed between the fistula closure and vaginal suture line. The muscle flap was based on the inferior epigastric vessels, and provided additional support to the urethra, bladder neck and bladder base. Urethrovaginalfistula repair with the rectus abdominis muscle flap was successful in all cases without recurrence.. Of the patients 5 (83%) were continent and able to void to completion at a mean follow-up of 23 months (range 2 to 66). 4. Other interposition material A range of non-traditional interposition flaps and grafts have been reported by several authors. All of the publications only report on small patient numbers without long term outcomes or continence data. Golomb et al. reported the use of a fascial patch, while adding a rectus fascia sling to a urethrovaginal fistula repair.[383] Omentum is extensively used in abdominal approaches to VVF, but Janez et al. used it during a vaginal approach in 3 patients with good results.[384] The gracilis muscle can be used as well, although the experience is limited. The graciloplasty was described by Ingelman-Sundberg in 1947 and has been adapted by other surgeons in the treatment of fistula. The number of patients reported is low as is the quality of the evidence. [385-387] Non-autologous material has been used as well. Lowman et al. described the use of porcine dermis interposition and a synthetic sling in an irradiated patient. Other biodegradable materials have been used, although the quality of available data is lowand is insufficient to advocate their use. [388] [389] Non-vascularized tissue grafts should be used with caution in such cases as the aetiology of the initial tissue damage resulting in fistula is often ischemic. b) Posterior approach In cases of high fistula with difficult vaginal access, a perineal pararectal approach has been described. Some variations exist in the incisions and dissection planes. The anterior sagittal transrectal approach (ASTRA technique) and the posterior sagittal pararectal approach only have been reported in small observational series. [390, 391][392-394]

pubic cystostomy, one was totally incontinent, and another had an urethrovaginal fistula. Three had an associated vaginal injury. All five patients underwent construction of a neourethra using a flipped anterior bladder-wall tube (FABWT) and have been followed for 18-80 months (mean 44 months). All patients were continent in the daytime and three were voiding spontaneously without the need for catheterization. Two were managed by clean intermittent catheterization (CIC), one per urethram and other via a continent abdominal stoma (Mitrofanoff). [395] A retropubicretrourethral technique has been described by Koriatim[396] This approach allows a urethrovesical flap tube to be fashioned to form a continent neourethra. Urodynamic studies showed that the proximal vesical and distal urethral components of the neourethra contribute to sphincteric function. For larger fistula an enwrapping technique has been described as well.[397]

5. COMPLICATIONS Little information can be found on complications after urethrovaginal fistula repair. A short report on 4 cases by Tehan et al. describes a disappointing experience in the transvaginal repair of these fistulas. These authors advocate a suprapubic bladder flap or bladder tube technique to achieve a functioning urethra. Complications following surgical repair have been fistula recurrence, urethral shortening and retraction, persistent reflux, bladder calculi, and bladder cancer [398].

6. FOLLOW UP In most series of urogenital fistula repair, follow-up is of very short duration. Dolan et al. investigated urinary and sexual symptoms and quality of life in a group of 31 women 50 months (median) after successful repair of urogenital fistula using the Bristol Female Lower Urinary Tract Symptom questionnaire. [399] All women had undergone urodynamic investigation prior to their repair surgery, and only36% had normal findings. Almost all women reported one or more symptoms, and for 65%, these caused at least ‘a bit of a problem’, although 87% said that their urinary symptoms had little or no impact on their quality of life. Symptoms were similar in urethrovaginal and vesicovaginal fistulae and were not significantly associated with prior functional abnormality.

7. RECOMMENDATIONS

c) Abdominal approach Female urethral injuries may cause serious morbidity with loss of the entire urethra in some cases. Ahmed et al. reported the results of construction of a neourethra by the flipped anterior bladder-tube technique in five girls aged 3-18 years (mean 8 years). All had pelvic fractures. Three patients came with a supra-

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Urethrovaginal fistula are preferably treated by a vaginal approach

C

A variety of autologous tissue interposition techniques have been described, but their value remains uncertain

C

Urethrovaginal fistula repair may be complicated by stress incontinence, urethral stricture and urethral shortening necessitating long-term follow-up

C

hysterectomy performed under the National Health Service in England - patterns of care between 2000 and 2008. 2012:(submitted).

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