A systematic review of outcome and outcome

International Urogynecology Journal https://doi.org/10.1007/s00192-018-3781-5

REVIEW ARTICLE

A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set Constantin M. Durnea 1,2 & Vasilios Pergialiotis 3 & James M. N. Duffy 4,5 & Lina Bergstrom 6 & Abdullatif Elfituri 1 & Stergios K. Doumouchtsis 1,3,6 & CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health Received: 7 May 2018 / Accepted: 12 July 2018 # The Author(s) 2018

Abstract Introduction We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality. Methods We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1–5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1–6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables. Results Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = −0.013; P = 0.918). Conclusions Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues. Keywords Anterior repair . Colporrhaphy . Core outcome sets . Cystocele . Outcomes . Outcome measures * Stergios K. Doumouchtsis [email protected] Constantin M. Durnea [email protected] 1

Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Rowan House, Dorking Road, Epsom, London KT18 7EG, UK

2

Nortwick Park Hospital, London North West University Healthcare NHS Trust, London, UK

3

Laboratory of Experimental Surgery and Surgical Research N.S. Christeas, Athens University Medical School, Athens, Greece

4

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK

5

Balliol College, University of Oxford, Oxford, UK

6

St George’s University of London, London, UK

Introduction The most common type of pelvic organ prolapse (PO) is anterior-compartment prolapse. Hendrix et al. demonstrated in a group of 16,616 postmenopausal women a prevalence of anterior-compartment prolapse of 34%, and this was much higher than the rates of apical- or posterior-compartment prolapse [1]. The aetiology of pelvic organ prolapse (POP) is complex and associated with various factors such as age, menopausal status and childbirth-related pelvic floor trauma [2, 3]. Possible surgical interventions include biological-graft, mesh and native tissue repair [4, 5]. The development of new surgical interventions is urgently required, and potential surgical

Int Urogynecol J

interventions require robust evaluation. Selecting appropriate efficacy and safety outcomes is a crucial step in designing randomised trials. Outcomes collected and reported in randomised trials should be relevant to a broad range of stakeholders, including women with anterior-compartment prolapse, healthcare professionals and researchers. For example, resolution of bladder symptoms is an important outcome for all stakeholders; however, it is not commonly reported across trials. Even when outcomes have been consistently reported, secondary research methods, including pair-wise meta-analysis, may be limited by the use of different definitions and measurement instruments [6, 7]. A core outcome set should help address these issues. The first stage in core outcome-set development is to evaluate outcome and outcome-measure reporting across published trials. Therefore, we systematically evaluated outcome and outcome-measure reporting in published randomised trials evaluating surgical interventions for anterior-compartment prolapse. In addition, we assessed the relationships between outcome reporting quality with other important variables, including year of publication, impact factor and methodological quality.

Materials and methods This systematic review is part of a wider project of the International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health (CHORUS) (i-chorus.org) and was registered with the Fig. 1 Study search and inclusion

Core Outcome Measures in Effectiveness Trials (COMET) initiative database, registration number 981, and with the International Prospective Register of Systematic Reviews (PROSPERO), registration identification CRD42017062456. We searched bibliographical databases comprising the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE and MEDLINE from inception to September 2017. The search strategy used several MeSH terms, including bladder prolapse, cystocele and POP. Randomised trials evaluating surgical interventions for anterior-compartment prolapse were eligible. We included trials evaluating the surgical management of anterior prolapse as a unicompartmental prolapse procedure, as well as trials in which anterior repair was undertaken in addition to other surgical interventions. Non-randomised studies, observational studies and case reports were excluded. Two researchers (CD and AE) independently screened the titles and abstracts of electronically retrieved articles. The articles potentially eligible for inclusion were retrieved in full text to assess eligibility, and reference lists were independently reviewed. Any discrepancies between the researchers were resolved by review of a third senior researcher (SKD). Two researchers (CD and AE) independently extracted the study characteristics, including year of publication, journal topicality (subspecialist, general obstetrics and gynaecology or general medicine), journal’s impact factor and commercial funding (yes/no). The journal’s impact factor was determined using InCites Journal Citation Reports (Clarivate Analytics, Thomson Reuters, New York, NY, USA). Funding status was identified by reviewing the article text and included the

2011

2013

2014

1996

2009

2017

2009

2000

Altman et al.a

Antosh et al.

Ballard et al.

Benson et al.

Borstad et al.a

Bray et al.

Carey et al.

Choe et al.a

Dias et al.a,c

2016

Delroy et al.a,b 2013

Dahlgren et al. 2011

da Silveira et al. 2014

Colombo et al.a 2000

Study Journal year

Author

4.78

29.1

British Journal of Obstetrics and Gynaecology International Urogynecology Journal Acta Obstetricia et Gynecologica Scandinavica International Urogynecology Journal S

2.2

2.48

SS

SS

SS

2.17

2.45

S

5

5

3

3

3

2

3

S

SS

3

G

4.64

European Journal N/A of Obstetrics & Gynaecology and Reproductive Biology British Journal of 4.64 Obstetrics and Gynaecology Journal of Urology 2.64

3

3

S

SS

5

3

4

G

S

G

6

6

3

5

3

3

5

5

4

3

5

6

5

No

No

No

88 No

79 Yes

135

184 Yes

71

40 No

139 Yes

60

184 No

80 No

150 No

60 No

389 Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

N/A

No

No

Yes

Yes

Yes

Anterior colporrhaphy

Conventional colporrhaphy

Native tissue repair

Antilogous vaginal wall slings Anterior colporrhaphy

Conventional vaginal repair

Suprapubic catheter

Anterior colporrhaphy TVT

Pelvic surgery for prolapse

Use of dilators post prolapse surgery Preop. bowel preparation


Impact Journal Jadad MOME Study Commercial Validated Intervention factor type3 score NT size funding questionnaire group 1 score use

International 2.17 Urogynecology Journal American Journal – of Obstetrics and Gynaecology International 2.84 Urogynecology Journal

New England Journal of Medicine Obstetrics and Gynaecology

Study characteristics

Table 1

Transvaginal mesh repair

Porcine skin graft

Synthetic mesh repair

Burch colposuspension

Micromesh

Mesh vaginal repair

Anterior colporrhaphy + TVT staged procedure Immediate removal of catheter

Abdominal surgery

Non-use of dilators post prolapse surgery Preop. non bowel preparation


Intervention group 2



Int Urogynecol J

American Journal 4 of Obstetrics and Gynaecology British Journal of 4.34 Obstetrics and Gynaecology The Lancet N/A N/A

2005

2011

Gandhi et al.a

Geller et al.

Glazener et al.c 2017

Guerette et al.a 2009

Glazener et al.b 2017

Health Technology Assessment

Acta Obstetricia et 1.94 Gynecologica Scandinavica

2007

Galvind et al.

Feldner et al.a,c 2012

Feldner et al.a,b 2010

4.69

5.87

2.66

2.45

El-Nazer et al.a 2012

2013

1.56

American Journal of Obstetrics and Gynaecology International Urogynecology Journal International Urogynecology Journal Clinical Science

2010

Ek et al.a

Farthmann et al.a

Neurourology and 3.01 Urodynamics

2012

Ek et al.a

S

G

G

S

S

G

G

SS

SS

S

SS

SS

SS

4

4

3

3

3

3

5

5

3

5

5

2

3

4

6

6

4

5

2

4

5

3

5

4

4

5

No

94 Yes

3087 No

1352 No

50

154 No

136 No

56 No

56 Yes

200 Yes

44 No

50 No

99 No

147 No

Yes

Yes

Yes

N/A

No

N/A

Yes

Yes

Yes

Yes

N/A

Yes

Yes

Anterior repair

Standard repair

Standard repair

Spontaneous postop. micturition


Small intestine submucosa graft 3-h catheterisation and vaginal tampon

Conventional anterior colporrhaphy Anterior colporrhaphy


Anterior trocar-guided transvaginal mesh repair Anterior colporrhaphy

Anterior colporrhaphy Anterior colporrhaphy

Intervention Impact Journal Jadad MOME Study Commercial Validated size funding questionnaire group 1 factor type3 score NT use score

Neurourology and Urodynamics International 2.53 Urogynecology Journal International 2.53 Urogynecology Journal

Study Journal year

de Tayrac et al.a 2012

Author

Table 1 (continued)

Mesh repair

Mesh repair

Micturition after bladder refill

Traditional colporrhaphy 24-h catheterisation and vaginal tampon Colporrhaphy and fascial patch

SIS graft

Partially absorbable mesh

Anterior colporrhaphy with lateral defects repair Trocar guided transvaginal mesh repair Transvaginal mesh repair

Transvaginal mesh repair Transvaginal mesh repair


Biological graft Biological graft



Int Urogynecol J

2004

2016

Hakvoort

Henn et al.

2010

2008

2010

2010

2010

2010

2016

Nieminen et al.a,c

Nieminen et al.a,c

Huang et al.

Hviid et al.a

Iglesia et al.

Kamilya et al.

Khalil et al.

Hiltunen et al.a,b 2007

2014

G

SS

SS

4.98

2.51

2.66

S

1.13 Journal of Obstetrics and Gynaecology Research Journal of Clinical 1.64 Anaesthesia S

S

4.98

Obstetrics and Gynaecology

SS

G

4.45

SS

S

4.75

1.83

S

0.23

5

3

5

3

3

3

3

3

5

2

3

5

6

6

3

3

2

4

4

6

3

4

No

57 No

200 No

65 No

61

90 No

202 No

202 No

202 No

80 No

100 No

106 No

No

N/A

Yes

Yes

N/A

No

No

No

N/A

N/A

N/A

General anaesthesia

Conventional colporrhaphy or uterosacral ligament suspension Catheter removal day 4 postop.

Conventional anterior repair

Removal of catheter on day 2 postop.



Vaginal vasoconstrictor infiltration Anterior colporrhaphy

4-day catheterisation

Anterior repair


2.66 International Urogynecology Journal

South African Journal of Obstetrics & Gynaecology British Journal of Obstetrics and Gynaecology International Urogynecology Journal Obstetrics and Gynaecology American Journal of Obstetrics and Gynaecology International Urogynecology Journal International Urogynecology Journal

Obstetrics and Gynaecology

Study Journal year

Gupta et al.a

Author

Table 1 (continued)

General anaesthesia +

Catheter removal day 1 postop.

Anterior repair + porcine skin collagen implants Vaginal colpopexy with mesh




Vaginal saline infiltration

1-day catheterisation

Anterior repair + porcine graft mesh Anterior repair + mesh





Int Urogynecol J

S

N/A

2007

Lazzeri et al.a

Lindholm et al. 1985

2014

Natale et al.a

2009

Miranda et al.a 2011

Minassian et al.a

Meschia et al.a 2003

Menefee et al.a 2011

McNanley et al. 2012

Mahuvrata et al. 2011

S

Journal of Urology 4.27

2013

Journal of obstetrics and gynaecology Canada

International Journal of Gynaecology and Obstetrics Journal of Obstetrics and Gynaecology Female Pelvic Medicine & Reconstructive Surgery Obstetrics and Gynaecology American Journal of Obstetrics and Gynaecology Neurourology and Urodynamics

2.84

1.42

2.71

2.96

SS

S

SS

S

S

SS

0.42

5.34

G

0.75

SS

SS

Lambin et al.a

International 2.66 Urogynecology Journal International 2.45 Urogynecology Journal

2010

Kringel et al.a

3

5

3

3

5

3

5

4

3

3

3

5

2

5

5

6

6

5

3

5

5

5

190 No

22 No

70 No

50 No

99 Yes

60 No

66 No

20 No

47 No

68 No

232 No

Yes

N/A

Yes

No

Yes

Yes

Yes

N/A

Yes

Yes

N/A


Conventional anterior colporrhaphy Anterior colporrhaphy with polyglactin 910 mesh

Anterior colporrhaphy Endopelvic fascia plication

Docusate sodium laxative postoperative

Mesh repair

Intraurethral catheterisation 24 h Anterior colporrhaphy with vaginal colposuspension Abdominal prolapse repair NO Burch colposuspension Phenoxybenzamine use


Study Journal year

Author

Table 1 (continued)

Abdominal paravaginal defect repair Anterior colporrhaphy without plication of pubovesical fascia Synthetic mesh

TVT + Anterior repair

Mesh repair

Other laxatives postoperative

No mesh

Biological graft

PDS

Suprapubic catheterisation 96 h

pudendal nerve block Intraurethral catheterisation 96 h Transvaginal mesh repair

Abdominal prolapse repair and Burch colposuspension Control



Vicryl


Int Urogynecol J

2015

2015

Pauls et al.

Ploege et al.

2014

2013

2015

2001

Robert et al.a

Rudnicki et al.a,b

Rudnicki et al.a,c

Sand et al.

2006

2007

2011

Segal et al.

Sivaslioglu et al.a

Stekkinger et al.

Schierlitz et al. 2013

2000

Quadri et al.a

Qatawneh et al. 2013

2013

International Urogynecology Journal International Urogynecology Journal American Journal of Obstetrics and Gynaecology International Urogynecology Journal Gynaecological Surgery International Urogynecology Journal Obstetrics and Gynaecology British Journal of Obstetrics and Gynaecology British Journal of Obstetrics and Gynaecology American Journal of Obstetrics and Gynaecology International Urogynecology Journal International Urogynecology Journal International Urogynecology Journal

Study Journal year

Park et al.a

Author

Table 1 (continued)

1.74

2.79

2.38

G

SS

SS

SS

S

2.72

2.45

G

G

2.9

2.9

S

SS

S

4.76

1.15

0.46

SS

S

5.23

1.83

SS

2.45

3

3

3

3

3

3

3

5

3

3

3

5

3

5

2

5

5

4

3

5

4

3

5

6

5

5

126

90

40

80

161

138

160

57

45

116

91

74

92

No

No

No

No

No

No

No

Yes

No

No

Yes

No

No

N/A

Yes

No

Yes

N/A

Yes

Yes

Yes

N/A

No

Yes

Yes

Yes

Trans urethral catheter


Local anaesthesia

Conventional pelvic repair

Conventional anterior colporrhaphy



Use of PGE-2

Native tissue repair

Prolapse surgery

Dexamethasone prior to surgery

Anterior repair + TVT

Intervention Impact Journal Jadad MOME Study Commercial Validated size funding questionnaire group 1 factor type3 score NT score use

S/pubic catheter


Conventional pelvic repair + TVT General anaesthesia

Use of mesh



Control

Mesh repair

Prolapse surgery + TVT

Placebo

TVT




Int Urogynecol J

2012

2014

Tamanini et al.a,c

Tamanini et al.a,c Tantanasis et al.a

2013

2011

2011

Turgal et al.a

Van et al.

Vollebregt et al.a,b

2012

2009

Tincello et al.a

Thiagamoorthy 2013 et al.

2008

2012

SS

2.45

S

2.96

SS

SS

2.39

3.67

G

S

2.4

4.18

S

1.72

Acta Obstetricia et Gynecologica Scandinavica International Urogynecology Journal British Journal of Obstetrics and Gynaecology European Journal of Obstetrics & Gynaecology and Reproductive Biology International Urogynecology Journal British Journal of Obstetrics and Gynaecology

S

G

G

5

5

3

3

3

5

2

4

4

4

6

6

5

2

4

6

2

5

5

5

No

No

125 No

125 No

179 No

40 No

31 No

190

50

92 No

100 No

100 No

Yes

Yes

N/A

No

Yes

N/A

No

Yes

Yes

Yes


1-day suprapubic catheterisation


Colposuspension + anterior repair

Use of postop. vaginal pack





Gynecologic and Obstetric investigation International Braz 1.24 J Urol: official journal of the Brazilian Society of Urology International Braz 1.24 J Urol: official journal of the Brazilian Society of Urology Journal of Urology 4.68

Study Journal year

Tamanini et al.a,b

Author

Table 1 (continued)


3-day suprapubic catheterisation


TVT + Anterior repair

No use of postop. vaginal pack

Transvaginal mesh repair Bladder base tape repair






Int Urogynecol J

American Journal of Obstetrics and Gynaecology American Journal of Obstetrics and Gynaecology International Urogynecology Journal New England Journal of Medicine Female Pelvic Medicine & Reconstructive Surgery Obstetrics and Gynaecology British Journal of Obstetrics and Gynaecology Journal of Sexual Medicine Journal of Minimally Invasive Gynaecology

2001

2011

2011

2012

2016

Weber et al.a,b

Chmielewski et al.a,c

Weemhoff et al.a

Wei et al.a

Westermann et al.

2012

Yuk et al.a 2.1

3.67

4.34

S

SS

S

S

SS

1.49

5.34

G

SS

2.39

29.36

G

G

5.34

2.72

3

3

5

5

4

5

3

4

2

3

6

6

6

5

6

6

4

3

No

87

59 No

No

59 No

194

93 No

337 No

246 No

114 No

114 No

N/A

Yes

Yes

Yes

Yes

Yes

N/A

No

No

Conventional colporrhaphy 2-point mesh

Conventional colporrhaphy Conventional colporrhaphy

Use of postop. vaginal pack

Postop. catheterisation for 2 days Anterior repair

Unilateral anterior colporrhaphy

Unilateral anterior colporrhaphy


Intervention Impact Journal Jadad MOME Study Commercial Validated size funding questionnaire group 1 factor type3 score NT score use

a

Studies focused on surgical management of anterior repair solely, b original study, c secondary analysis

SS subspecialty (urogynaecology), S specialty (obs/gyn), G general, TVT tension free vaginal tape (retropubic tape), PDS polydioxanone

2011

Milani et al.c

Withagen et al.c 2011

Withagen et al.b 2011

Journal of Sexual Medicine

Study Journal year

Vollebregt et al.a,c

Author

Table 1 (continued)

Trocar-guided Mesh 4-point mesh


No use of postop. vaginal pack

Postop. catheterisation for 5 days TVT + Anterior repair


Transvaginal anterior or posterior mesh repair Anterior colporrhaphy






Int Urogynecol J

Int Urogynecol J

donation of equipment or other resources. Two researchers (CD and AE) independently assessed the methodological quality of included randomised trials using the modified Jadad criteria (score range 1–5) [8]. Studies were assessed as high quality when they achieved a score >4. Outcome reporting quality was assessed using the Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria (score range 1–5) [9]. Studies were assessed as high quality when they achieved a score >4. The non-parametric Spearman’s rank correlation coefficient (Spearman’s rho) was used to explore univariate associations between outcome reporting quality and impact factor during the year of publication, year of publication and methodological quality. Multivariate linear regression analysis using the Enter model was also undertaken to assess the combined association of quality of outcome reporting and journal type, impact factor during the year of publication, year of publication and methodological quality (independent variables) with outcome reporting (dependent variable). All tests were two-tailed. Statistical significance was set at 0.05, and analyses were conducted using the SPSS statistical software (IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA). This study was reported with reference to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [6].

Results In total, 2482 titles and abstracts were screened, and 231 potentially relevant studies were examined in detail (Fig. 1). Sixty-eight randomised trials, reporting data from 10,499 participants, met the inclusion criteria (Table 1) [5, 10–88]. Additionally, 12 randomised trials published longterm follow-up data [5, 22, 29, 39, 40, 64, 71, 72, 79, 81, 86, 87]. Table 2 Most commonly reported outcome domains

Trials were published between 1985 and 2017, with most being published in subspecialty journals (33/80; 41%). Trials were frequently published in journals with an impact factor 7 days.

5 4 4 2 1 1 1 1 1 1 1

Prolonged catheterisation Pyelectasia Residual urine volume Urinary retention prevention with intravesically administered prostaglandin-E2 Urinary retention rates Postoperative vaginal packing Bleeding postoperatively (with/out vaginal pack use) (compared with menstrual average)

1 1 1 1 1 1

Retreatment success rates Symptom improvement Functional recurrence Healing abnormalities

25 11 2 1 1 5 3 3 3 2 1 1 1 1

Int Urogynecol J Table 3 (continued) Outcomes

Reporting studies

Need for subsequent anti-incontinence surgery Treatment of overactive bladder

1 1

Table 4 Outcome measures reported in 80 randomised controlled trials (RCTs) evaluating surgical management of anterior-compartment prolapse Outcomes

Mesh-related outcomes Mesh erosion Mesh shrinkage

6 2

Degree of morbidity in mesh vs. native tissue Cost/effectiveness

1

Cost-effectiveness of treatment

2

Cost of procedure

1

Recruitment feasibility Number of patients agreed to participate

1

Number of eligible patients

1

Physician acceptance and protocol Rate of recruitment compliance

1 1

UTI urinary tract infection, SUI stress urinary incontinence, QoL quality of life

(PFDI-20) (9 trials; 11%). QoL was measured using the Prolapse Quality of Life (P-QoL) (10 trials; 12%), Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) (8 trials; 10%) and the Incontinence Impact Questionnaire Short Form (IIQ-7) (6 trials; 7%). Table 5 summarises our main findings, demonstrating the most frequently reported outcomes. It reveals the significant discrepancies in terms of outcome reporting. We observed a moderate correlation between outcome reporting quality and year of publication in the univariate analysis (r 0.458; p < .001) and study quality (r 0.409; p < .001) (Table 6). The latter index significantly affected outcome reporting in the multivariate logistic regression (β = 0.412; p = .018).

Discussion Summary of main findings This study demonstrated considerable variation in outcome and outcome-measure reporting across published trials evaluating surgical interventions for anterior-compartment prolapse. Commonly reported outcomes included normalised anatomy, QoL and pain. Patient-reported outcomes were infrequently reported, and a minority of trials reported on patient satisfaction. Mesh-related complications, including erosion, shrinkage and morbidity, were rarely reported. Forty-five different questionnaires were used as measurement instruments; most were validated. Only a few trials considered cost effectiveness.

No of reporting studies

Prolapse treatment success rate Anatomical success rate POP-Q < 2 Anatomical success rate (POP-Q ≤ 1) Anatomical success rate (postoperative POP-Q stage improvement) Anatomical success rate (POP above hymen) Anatomical success rate POP-Q ≤ 2 Anatomical success rate (POP-Q < 2 vs. POP-Q ≤ 1)

23 5 5 3 2 1

Anatomical success rate POP-Q Index (POP-Q-I) = 0 Anatomical success rate (postoperative POP-Q + BW stage improvement) Anatomical success rate (cotton swab mobility test)

1 1

Composite success rate (POP-Q < 2 + UDI question 16 negative Composite success rate (POP above hymen + VAS >20 (0–100 scale)) Composite success rate (POP above hymen + no symptoms) Composite success rate (apex below levator plate + no symptoms) Denovo POP in untreated compartments (POP-Q ≥ 2) Denovo POP in untreated compartments (POP ≥ hymen) Recurrence rate of POP (halfway BW stage change) Perioperative complications and observations Postoperative hospital stay length (days)

1

Blood loss (ml) Duration of operation (min) PONV (postoperative nausea and vomiting), visual analogue scale [VAS (0–10)] PONV scale PONV QoR (quality of recovery) score > 50 Recovery time (days) PONV intensity score [QoR (0–40)] Blood pressure (mmHg) Heart rate (beats/min) Consistency of bowel movement (Bristol stool scale) Constipation perioperatively (Rome III constipation questionnaire) Time to mobilisation (days) Pain VAS (0–10) VAS (0–100) VAS (not specified) Mcgill pain questionnaire Verbal numerical pain scale (0–10) Baudelocque’s questionnaire Nonvalidated questionnaire (0–3) Postoperative catheterisation

1

1 1 1 1 1 1

11 8 6 2 2 2 2 1 1 1 1 1 1 5 2 2 2 1 1 1

Int Urogynecol J Table 4 (continued) Outcomes

Table 4 (continued) No of reporting studies

Postoperative catheterisation duration (days) Day of spontaneous voiding (days)

4 3

Bacterial count in the urine

1

Residual urine volume (ml) First PVR (postvoid residual volume) > 150 ml First PVR > 1500 ml Mean residual urine volume pre- and postoperatively (ml) Recatheterisation if PVR >200 ml Prediction of voiding dysfunction >7 days (positive predictive value) Diagnostic accuracy of two voiding trial methods (sensitivity/specificity) Postoperative vaginal packing Bleeding postoperatively (with/out vaginal pack use) (compared with menstrual average) Bleeding postoperatively (with/out vaginal pack use) [FBC change and volume (ml)] Blood pressure (mmHg) Heart rate (beats/min) Blood transfusion indicated (yes/no) Vaginal haematoma (TVUSS) Vaginal infection (HVS) Bother related to the pack (VAS 0–100) Presence of symptoms posttreatment PISQ-12 (Pelvic Organ Prolapse Urinary Incontinence–Sexual Questionnaire) UDI-6 (Urogenital Distress Inventory) PFDI-20 (Pelvic Floor Distress Inventory) SUI urodynamic studies DDI (Defecatory Distress Inventory) ICIQ-UI SF (International Consultation on Incontinence Questionnaire–Short Form) SUI cough test (presence of leakage) FSFI (Female Sexual Function Index) ICIQ-BS (International Consultation on Incontinence Questionnaire–Bowel Symptoms) PGI-I (Patient Global Impression of Improvement) OAB-V8 (Overactive Bladder-Validated 8-question) POPDI-6 (Pelvic Organ Prolapse Distress Inventory) POP-SS (Pelvic Organ Prolapse Severity of Symptoms) UDI-I (Urogenital Distress Inventory–Irritative) UDI-O (Urogenital Distress Inventory-Obstructive) UDI-S (Urogenital Distress Inventory–Stress) AUASS [American Urological Association Symptom Score (urinary)] CRADI-8 (Colorectal–Anal Distress Inventory) CRAIQ-7 (Colorectal–Anal Impact Questionnaire) Danish prolapse questionnaire ICIQ-VS (International Consultation on Incontinence Questionnaire–Vaginal Symptoms)

Outcomes

No of reporting studies

1 1

MESAAQ (Medical Epidemiologic and Social Aspects of Ageing Questionnaire) MHU (French Urinary Dysfunction Measurement Scale) MSHQ (Male Sexual Health Questionnaire) PGI-S (Patient Global Impression of Severity)

1 1

1 1

QS-F (Sexual Quotient–Female Version) SUI number of daily pads

1 1

1 1 1

1 1 1 1 1 1 1 1 13 11 9 7 5 4 4 2 2 2 2 2 2 2 2 2 1 1 1 1 1 1

1

Impact on quality of life P-QoL (Prolapse Quality of Life) 10 PFIQ-7 (Pelvic Floor Impact Questionnaire– 8 Short Form) IIQ-7 (Incontinence Impact Questionnaire–Short Form) 6 ICIQ-UI SF (International Consultation on Incontinence 4 Questionnaire–Urinary Symptoms) ICIQ-VS (International Consultation on Incontinence 3 Questionnaire–Vaginal Symptoms) KHQ (King’s Health Questionnaire) 3 UIQ-7 (Urogenital Impact Questionnaire) DDI (Defecatory Distress Inventory) EQ5D [Quality of Life (EuroQol)] POPIQ-7 (Pelvic Floor Impact Questionnaire–Prolapse) VAS (0–10)

3 2 2 2 2

CRAIQ-7 (Colorectal–Anal Impact Questionnaire) PSI-QOL (Prolapse Symptom Inventory and Quality of Life Questionnaire) SF-12 (12-Item Short-Form Health Survey)

1 1

SF-36 (36-Item Short-Form Health Survey) Satisfaction Patient satisfaction with treatment, VAS (0–10) Patient satisfaction with treatment, PGI (Patient Global Improvement) Patient satisfaction with treatment (yes/no) Patient satisfaction with treatment, VAS (0–100) Patient satisfaction with treatment, VAS (0–4) Patient satisfaction with treatment, custom (0–5)

1

Patient acceptability of preoperative bowel preparation, VAS) (0–4) Surgeon satisfaction with preoperative bowel preparation, Likert scale (0–4) Surgeon ease to perform operation, Likert scale (0–4) Surgeon’s satisfaction with operation, VAS (0–100) Cost/effectiveness Incremental cost per quality-adjusted life-year (QALY) Cost of procedure (US$)

1

3 3 3 2 1 1 1 1 1 1 2 1

TVUSS transvaginal ultrasound scan, HVS high vaginal swab, FBC full blood count

Strengths and limitations Strengths of our systematic review include originality, a rigorous search strategy and methodological robustness. To our

200

190 184 184 179 161 160

154 150 147 139 138

135 126 125

116 114 114 106 100

100 99 99

Thiagamoorthy et al. da Silveira et al. Borstad et al. Van et al. Sand et al. Rudnicki et al.

Gandhi et al. Ballard et al. de Tayrac et al. Carey et al. Rudnicki et al.

Dahlgren et al. Stekkinger et al. Vollebregt et al.

Qatawneh et al. Weber et al. Chmielewski et al. Gupta et al. Tamanini et al.

Hakvoort Menefee et al. Ek et al.

203 202

Nieminen et al. Hiltunen et al.

200 194 190

389 337 246

Altman et al. Wei et al. Weemhoff et al.

Kamilya et al. Withagen et al. Natale et al.

1352

Glazener et al.

Farthmann et al.

Sample size (N)

x x

x

x

x

x x

x

x

x

x

x x x x x

x

x

x

x

x x

x

x

x

x x

x

x

x

x x

x

x x x

Sexual dysfunction symptoms

x

x x x

x

x x

x x

x x

x

x

x

x

Anatomical Quality of life and Complications intra-/ prolapse stage impact from postoperatively symptoms

Outcomes

Reported outcomes by by more than eight studies with greater than 93 participants (median value)

Study

Table 5

x

x

x

x x

x

Postoperative hospital stay length

x

x

x

x x x

x

x

Urinary Patient symptoms satisfaction with treatment

x

x

x

x

x

x

Prolapse symptoms postoperatively

x

x

x

Postoperative pain

Int Urogynecol J

Postoperative pain

Int Urogynecol J Table 6 quality

Univariate and multivariate correlation with outcome reporting

x

Univariate

3 9

P value

Beta

P value

Study quality (Jadad)

00.409