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
Anterior colporrhaphy
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
Transvaginal mesh repair
Intervention group 2
Intervention group 3
Intervention group 4
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
Anterior colporrhaphy
Small intestine submucosa graft 3-h catheterisation and vaginal tampon
Conventional anterior colporrhaphy 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
Intervention group 2
Biological graft Biological graft
Intervention group 3
Intervention group 4
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.
Anterior colporrhaphy
Anterior colporrhaphy
Vaginal vasoconstrictor infiltration Anterior colporrhaphy
4-day catheterisation
Anterior repair
Intervention Impact Journal Jadad MOME Study Commercial Validated size funding questionnaire group 1 factor type3 score NT use score
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
Removal of catheter on day 3 postop.
Transvaginal mesh repair
Transvaginal mesh repair Transvaginal mesh repair
Vaginal saline infiltration
1-day catheterisation
Anterior repair + porcine graft mesh Anterior repair + mesh
Intervention group 2
Removal of catheter on day 4 postop.
Intervention group 3
Intervention group 4
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
Anterior colporrhaphy
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
Intervention Impact Journal Jadad MOME Study Commercial Validated size funding questionnaire group 1 factor type3 score NT use score
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
Intervention group 3
Intervention group 2
Vicryl
Intervention group 4
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
Anterior colporrhaphy
Local anaesthesia
Conventional pelvic repair
Conventional anterior colporrhaphy
Anterior colporrhaphy
Anterior colporrhaphy 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
Transvaginal mesh repair
Conventional pelvic repair + TVT General anaesthesia
Use of mesh
Transvaginal mesh repair
Transvaginal mesh repair Transvaginal mesh repair
Control
Mesh repair
Prolapse surgery + TVT
Placebo
TVT
Intervention group 2
Intervention group 3
Intervention group 4
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
Anterior colporrhaphy
1-day suprapubic catheterisation
Anterior colporrhaphy
Colposuspension + anterior repair
Use of postop. vaginal pack
Anterior colporrhaphy 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
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)
Transvaginal mesh repair
3-day suprapubic catheterisation
Transvaginal mesh repair
TVT + Anterior repair
No use of postop. vaginal pack
Transvaginal mesh repair Bladder base tape repair
Transvaginal mesh repair
Transvaginal mesh repair
Intervention group 2
Intervention group 3
Intervention group 4
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
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
Transvaginal mesh repair Transvaginal mesh repair
No use of postop. vaginal pack
Postop. catheterisation for 5 days TVT + Anterior repair
Anterior colporrhaphy
Transvaginal anterior or posterior mesh repair Anterior colporrhaphy
Intervention group 2
Transvaginal mesh repair
Transvaginal mesh repair
Intervention group 3
Intervention group 4
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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