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International Urogynecology Journal

, Volume 29, Issue 12, pp 1727–1745 | Cite as

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
  • Vasilios Pergialiotis
  • James M. N. Duffy
  • Lina Bergstrom
  • Abdullatif Elfituri
  • Stergios K. Doumouchtsis
  • CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health
Open Access
Review Article
  • 101 Downloads

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 

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 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 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 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, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88]. Additionally, 12 randomised trials published long-term follow-up data [5, 22, 29, 39, 40, 64, 71, 72, 79, 81, 86, 87]
Fig. 1

Study search and inclusion

Table 1

Study characteristics

Author

Study year

Journal

Impact factor

Journal type3

Jadad score

MOMENT score

Study size

Commercial funding

Validated questionnaire use

Intervention group 1

Intervention group 2

Intervention group 3

Intervention group 4

Altman et al.a

2011

New England Journal of Medicine

29.1

G

4

5

389

Yes

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Antosh et al.

2013

Obstetrics and Gynaecology

4.78

S

3

6

60

No

Yes

Use of dilators post prolapse surgery

Non-use of dilators post prolapse surgery

  

Ballard et al.

2014

International Urogynecology Journal

2.17

G

5

5

150

No

Yes

Preop. bowel preparation

Preop. non bowel preparation

  

Benson et al.

1996

American Journal of Obstetrics and Gynaecology

S

3

3

80

No

No

Pelvic surgery for prolapse

Abdominal surgery

  

Borstad et al.a

2009

International Urogynecology Journal

2.84

SS

3

4

184

No

No

Anterior colporrhaphy TVT

Anterior colporrhaphy + TVT staged procedure

  

Bray et al.

2017

European Journal of Obstetrics & Gynaecology and Reproductive Biology

N/A

G

3

5

60

No

N/A

Suprapubic catheter

Immediate removal of catheter

  

Carey et al.

2009

British Journal of Obstetrics and Gynaecology

4.64

S

3

5

139

Yes

Yes

Conventional vaginal repair

Mesh vaginal repair

  

Choe et al.a

2000

Journal of Urology

2.64

SS

2

3

40

No

Yes

Antilogous vaginal wall slings

Micromesh

  

Colombo et al.a

2000

British Journal of Obstetrics and Gynaecology

4.64

S

3

3

71

No

No

Anterior colporrhaphy

Burch colposuspension

  

da Silveira et al.

2014

International Urogynecology Journal

2.17

SS

3

5

184

Yes

Yes

Native tissue repair

Synthetic mesh repair

  

Dahlgren et al.

2011

Acta Obstetricia et Gynecologica Scandinavica

2.2

S

3

3

135

No

Yes

Conventional colporrhaphy

Porcine skin graft

  

Delroy et al.a,b

2013

International Urogynecology Journal

2.45

SS

5

6

79

Yes

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Dias et al.a,c

2016

Neurourology and Urodynamics

2.48

SS

5

6

88

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

de Tayrac et al.a

2012

International Urogynecology Journal

2.53

SS

3

5

147

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Ek et al.a

2012

International Urogynecology Journal

2.53

SS

2

4

99

No

Yes

Anterior trocar-guided transvaginal mesh repair

Anterior colporrhaphy with lateral defects repair

  

Ek et al.a

2010

Neurourology and Urodynamics

3.01

SS

5

4

50

No

N/A

Anterior colporrhaphy

Trocar guided transvaginal mesh repair

  

El-Nazer et al.a

2012

American Journal of Obstetrics and Gynaecology

1.56

S

5

5

44

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Farthmann et al.a

2013

International Urogynecology Journal

2.45

SS

3

3

200

Yes

Yes

Conventional anterior colporrhaphy

Partially absorbable mesh

  

Feldner et al.a,b

2010

International Urogynecology Journal

2.66

SS

5

5

56

Yes

Yes

Anterior colporrhaphy

SIS graft

  

Feldner et al.a,c

2012

Clinical Science

5.87

G

5

4

56

No

Yes

Small intestine submucosa graft

Traditional colporrhaphy

  

Galvind et al.

2007

Acta Obstetricia et Gynecologica Scandinavica

1.94

G

3

2

136

No

N/A

3-h catheterisation and vaginal tampon

24-h catheterisation and vaginal tampon

  

Gandhi et al.a

2005

American Journal of Obstetrics and Gynaecology

4

S

3

5

154

No

No

Anterior colporrhaphy

Colporrhaphy and fascial patch

  

Geller et al.

2011

British Journal of Obstetrics and Gynaecology

4.34

S

3

4

50

No

N/A

Spontaneous postop. micturition

Micturition after bladder refill

  

Glazener et al.b

2017

The Lancet

N/A

G

3

6

1352

No

Yes

Standard repair

Mesh repair

Biological graft

 

Glazener et al.c

2017

Health Technology Assessment

N/A

G

4

6

3087

No

Yes

Standard repair

Mesh repair

Biological graft

 

Guerette et al.a

2009

Obstetrics and Gynaecology

4.69

S

4

4

94

Yes

Yes

Anterior repair

Anterior repair + porcine graft mesh

  

Gupta et al.a

2014

South African Journal of Obstetrics & Gynaecology

0.23

S

3

4

106

No

N/A

Anterior repair

Anterior repair + mesh

  

Hakvoort

2004

British Journal of Obstetrics and Gynaecology

4.75

S

2

3

100

No

N/A

4-day catheterisation

1-day catheterisation

  

Henn et al.

2016

International Urogynecology Journal

1.83

SS

5

6

80

No

N/A

Vaginal vasoconstrictor infiltration

Vaginal saline infiltration

  

Hiltunen et al.a,b

2007

Obstetrics and Gynaecology

4.45

G

3

4

202

No

No

Anterior colporrhaphy

Transvaginal mesh repair

  

Nieminen et al.a,c

2010

American Journal of Obstetrics and Gynaecology

4.98

G

3

4

202

No

No

Anterior colporrhaphy

Transvaginal mesh repair

  

Nieminen et al.a,c

2008

International Urogynecology Journal

2.51

SS

3

2

202

No

No

Anterior colporrhaphy

Transvaginal mesh repair

  

Huang et al.

2010

International Urogynecology Journal

2.66

SS

3

3

90

No

N/A

Removal of catheter on day 2 postop.

Removal of catheter on day 3 postop.

Removal of catheter on day 4 postop.

 

Hviid et al.a

2010

International Urogynecology Journal

2.66

SS

3

3

61

No

Yes

Conventional anterior repair

Anterior repair + porcine skin collagen implants

  

Iglesia et al.

2010

Obstetrics and Gynaecology

4.98

S

5

6

65

No

Yes

Conventional colporrhaphy or uterosacral ligament suspension

Vaginal colpopexy with mesh

  

Kamilya et al.

2010

Journal of Obstetrics and Gynaecology Research

1.13

S

3

6

200

No

N/A

Catheter removal day 4 postop.

Catheter removal day 1 postop.

  

Khalil et al.

2016

Journal of Clinical Anaesthesia

1.64

S

5

5

57

No

No

General anaesthesia

General anaesthesia + pudendal nerve block

  

Kringel et al.a

2010

International Urogynecology Journal

2.66

SS

3

5

232

No

N/A

Intraurethral catheterisation 24 h

Intraurethral catheterisation 96 h

Suprapubic catheterisation 96 h

 

Lambin et al.a

2013

International Urogynecology Journal

2.45

SS

3

5

68

No

Yes

Anterior colporrhaphy with vaginal colposuspension

Transvaginal mesh repair

  

Lazzeri et al.a

2007

Journal of Urology

4.27

S

3

5

47

No

Yes

Abdominal prolapse repair NO Burch colposuspension

Abdominal prolapse repair and Burch colposuspension

  

Lindholm et al.

1985

International Journal of Gynaecology and Obstetrics

N/A

S

4

3

20

No

N/A

Phenoxybenzamine use

Control

  

Mahuvrata et al.

2011

Journal of Obstetrics and Gynaecology

0.75

G

5

5

66

No

Yes

Mesh repair

No mesh

PDS

Vicryl

McNanley et al.

2012

Female Pelvic Medicine & Reconstructive Surgery

0.42

SS

3

6

60

No

Yes

Docusate sodium laxative postoperative

Other laxatives postoperative

  

Menefee et al.a

2011

Obstetrics and Gynaecology

5.34

S

5

6

99

Yes

Yes

Anterior colporrhaphy

Mesh repair

Biological graft

 

Meschia et al.a

2003

American Journal of Obstetrics and Gynaecology

2.96

S

3

5

50

No

No

Endopelvic fascia plication

TVT + Anterior repair

  

Minassian et al.a

2014

Neurourology and Urodynamics

2.71

SS

3

5

70

No

Yes

Conventional anterior colporrhaphy

Abdominal paravaginal defect repair

  

Miranda et al.a

2011

Journal of obstetrics and gynaecology Canada

1.42

S

5

2

22

No

N/A

Anterior colporrhaphy with polyglactin 910 mesh

Anterior colporrhaphy without plication of pubovesical fascia

  

Natale et al.a

2009

International Urogynecology Journal

2.84

SS

3

5

190

No

Yes

Anterior colporrhaphy

Synthetic mesh

  

Park et al.a

2013

International Urogynecology Journal

2.45

SS

3

5

92

No

Yes

Anterior repair + TVT

TVT

  

Pauls et al.

2015

American Journal of Obstetrics and Gynaecology

5.23

S

5

5

74

No

Yes

Dexamethasone prior to surgery

Placebo

  

Ploege et al.

2015

International Urogynecology Journal

1.83

SS

3

6

91

Yes

Yes

Prolapse surgery

Prolapse surgery + TVT

  

Qatawneh et al.

2013

Gynaecological Surgery

0.46

S

3

5

116

No

No

Native tissue repair

Mesh repair

  

Quadri et al.a

2000

International Urogynecology Journal

1.15

SS

3

3

45

No

N/A

Use of PGE-2

Control

  

Robert et al.a

2014

Obstetrics and Gynaecology

4.76

S

5

4

57

Yes

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Rudnicki et al.a,b

2013

British Journal of Obstetrics and Gynaecology

2.9

G

3

5

160

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Rudnicki et al.a,c

2015

British Journal of Obstetrics and Gynaecology

2.9

G

3

3

138

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Sand et al.

2001

American Journal of Obstetrics and Gynaecology

2.72

S

3

4

161

No

N/A

Conventional anterior colporrhaphy

Use of mesh

  

Schierlitz et al.

2013

International Urogynecology Journal

2.45

SS

3

5

80

No

Yes

Conventional pelvic repair

Conventional pelvic repair + TVT

  

Segal et al.

2006

International Urogynecology Journal

2.38

SS

3

5

40

No

No

Local anaesthesia

General anaesthesia

  

Sivaslioglu et al.a

2007

International Urogynecology Journal

2.79

SS

3

2

90

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Stekkinger et al.

2011

Gynecologic and Obstetric investigation

1.74

G

3

5

126

No

N/A

Trans urethral catheter

S/pubic catheter

  

Tamanini et al.a,b

2012

International Braz J Urol: official journal of the Brazilian Society of Urology

1.24

G

4

5

100

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Tamanini et al.a,c

2012

International Braz J Urol: official journal of the Brazilian Society of Urology

1.24

G

4

5

100

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Tamanini et al.a,c

2014

Journal of Urology

4.68

S

4

5

92

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Tantanasis et al.a

2008

Acta Obstetricia et Gynecologica Scandinavica

1.72

S

2

2

50

No

No

Anterior colporrhaphy

Bladder base tape repair

  

Thiagamoorthy et al.

2013

International Urogynecology Journal

2.45

SS

5

6

190

No

N/A

Use of postop. vaginal pack

No use of postop. vaginal pack

  

Tincello et al.a

2009

British Journal of Obstetrics and Gynaecology

4.18

S

3

4

31

No

Yes

Colposuspension + anterior repair

TVT + Anterior repair

  

Turgal et al.a

2013

European Journal of Obstetrics & Gynaecology and Reproductive Biology

2.4

G

3

2

40

No

No

Anterior colporrhaphy

Transvaginal mesh repair

  

Van et al.

2011

International Urogynecology Journal

2.39

SS

3

5

179

No

N/A

1-day suprapubic catheterisation

3-day suprapubic catheterisation

  

Vollebregt et al.a,b

2011

British Journal of Obstetrics and Gynaecology

2.96

S

5

6

125

No

Yes

Anterior colporrhaphy

Transvaginal mesh repair

  

Vollebregt et al.a,c

2012

Journal of Sexual Medicine

3.67

SS

5

6

125

No

Yes

Anterior colporrhaphy

Transvaginal anterior or posterior mesh repair

  

Weber et al.a,b

2001

American Journal of Obstetrics and Gynaecology

2.72

G

2

3

114

No

No

Unilateral anterior colporrhaphy

Anterior colporrhaphy

Transvaginal mesh repair

 

Chmielewski et al.a,c

2011

American Journal of Obstetrics and Gynaecology

5.34

G

4

4

114

No

No

Unilateral anterior colporrhaphy

Anterior colporrhaphy

Transvaginal mesh repair

 

Weemhoff et al.a

2011

International Urogynecology Journal

2.39

SS

3

6

246

No

N/A

Postop. catheterisation for 2 days

Postop. catheterisation for 5 days

  

Wei et al.a

2012

New England Journal of Medicine

29.36

G

5

6

337

No

Yes

Anterior repair

TVT + Anterior repair

  

Westermann et al.

2016

Female Pelvic Medicine & Reconstructive Surgery

1.49

SS

4

5

93

No

Yes

Use of postop. vaginal pack

No use of postop. vaginal pack

  

Withagen et al.b

2011

Obstetrics and Gynaecology

5.34

S

5

6

194

No

Yes

Conventional colporrhaphy

Transvaginal mesh repair

  

Withagen et al.c

2011

British Journal of Obstetrics and Gynaecology

4.34

S

5

6

59

No

Yes

Conventional colporrhaphy

Transvaginal mesh repair

  

Milani et al.c

2011

Journal of Sexual Medicine

3.67

SS

3

6

59

No

Yes

Conventional colporrhaphy

Trocar-guided Mesh

  

Yuk et al.a

2012

Journal of Minimally Invasive Gynaecology

2.1

S

3

3

87

No

N/A

2-point mesh

4-point mesh

  

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

aStudies focused on surgical management of anterior repair solely, boriginal study, csecondary analysis

.
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 <3 [median = 2.7; interquartile range (IQR) = 2.2–4.3] and were generally small (median = 93; IQR = 60–154). Ten trials (14%) declared commercial funding. The methodological quality and outcome reporting quality varied considerably between trials (Table 1). One hundred different outcomes were organised into 11 thematic domains. The three most commonly reported thematic domains were presence of symptoms posttreatment (50 trials, 28 outcomes; 28 outcome measures), prolapse treatment success rates (47 trials; 3 outcomes; 16 outcome measures) and perioperative complications (46 trials; 15 outcomes; 13 outcome measures) (Table 2). Commonly reported outcomes were anatomical prolapse stage (43 trials; 54%), commonly assessed using the Pelvic Organ Prolapse Quantification (POP-Q) instrument (35 trials; 81%), QoL (25 trials; 31%); and intra- and postoperative complications (23 trials; 29%). Patient-reported outcomes were infrequently reported; for example, a minority of trials reported prolapse symptoms (9 trials; 11%), urinary symptoms (11 trials; 14%) and sexual dysfunction (14 trials; 17%) (Table 3). Eleven trials (14%) reported patient satisfaction.
Table 2

Most commonly reported outcome domains

Outcome domains

RCTs reporting on the domain

Outcomes reported

Outcome measures reported

Presence of symptoms posttreatment

50

28

28

Prolapse treatment success rate

47

3

16

Perioperative complications and observations

46

15

13

Quality of life and satisfaction with treatment

40

5

25

Treatment success evaluation

15

11

Postoperative catheterisation

10

17

10

Pain

9

4

7

Mesh-related outcomes

8

3

RCT randomised controlled trial

Table 3

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

Outcomes

Reporting studies

Prolapse treatment success rate

Anatomical prolapse stage

43

Composite anatomical/functional success rate

3

Urethral mobility

1

Perioperative complications and observations

Complications intra-/postoperatively

23

Postoperative hospital stay length

11

Blood loss intraoperatively

6

Duration of operation

6

Quality and time of recovery

4

Postoperative nausea and vomiting

3

Bleeding postoperatively (with/out vaginal pack use)

2

Constipation preoperatively

2

Blood pressure

2

Blood transfusion indicated

2

Heart rate change

2

Consistency of bowel movement postoperatively

1

Intra- and postoperative morbidity

1

Time to first postoperative bowel movement

1

Time to mobilisation

1

Pain

Postoperative pain

8

Intraoperative requirement of analgesics

1

Total analgesic consumption

1

Pain level associated with first postoperative bowel movement

1

Postoperative catheterisation

Postoperative UTI

5

Recatheterisation rates

5

Postoperative catheterisation duration

4

First postvoid residual volume

4

Time to normal spontaneous voiding

2

Acute urinary retention

1

Bacterial count in the urine

1

Catheter blockage

1

Day of spontaneous voiding

1

Diagnostic accuracy of different voiding trial methods

1

Mean residual urine volume pre- and postoperatively

1

Prediction of voiding dysfunction lasting >7 days.

1

Prolonged catheterisation

1

Pyelectasia

1

Residual urine volume

1

Urinary retention prevention with intravesically administered prostaglandin-E2

1

Urinary retention rates

1

Postoperative vaginal packing

Bleeding postoperatively (with/out vaginal pack use) (compared with menstrual average)

1

Bleeding postoperatively (with/out vaginal pack use)

1

Presence of vaginal haematoma

1

Presence of vaginal infection

1

Bother related to the pack

1

Presence of symptoms posttreatment

Sexual dysfunction symptoms

14

Urinary symptoms

11

Prolapse symptoms postoperatively

9

Dyspareunia

6

SUI postoperatively

5

De novo SUI postoperatively

4

Change in urinary symptoms (any)

3

Prolapse symptoms severity

3

De novo urinary urgency

2

Postoperative urinary symptoms

2

Urinary symptoms severity

2

Bowel symptoms

2

Faecal incontinence

2

Postoperative bowel symptoms

2

Change in incontinence rates

1

De novo urinary symptoms

1

De novo voiding difficulty

1

Urgency and urge urinary incontinence

1

Worsening urinary symptoms (any)

1

Obstructed defecation

1

Back pain improvement

1

Change in a pelvic symptom score

1

Change of vaginal symptoms

1

Symptomatic prolapse improvement

1

Time of prolapse recurrence

1

De novo dyspareunia

1

Sexual function in partner

1

QoL and satisfaction with treatment

QoL and impact from symptoms evaluation

25

Patient satisfaction with treatment

11

Surgeon satisfaction with operation

2

Patient acceptability of preoperative bowel preparation

1

Surgeon—ease of procedure

1

Treatment success evaluation

Symptoms—presence posttreatment

5

Subjective cure rates

3

Cure of SUI postoperatively

3

Reoperation rates

3

Symptoms—bother change

2

Retreatment success rates

1

Symptom improvement

1

Functional recurrence

1

Healing abnormalities

1

Need for subsequent anti-incontinence surgery

1

Treatment of overactive bladder

1

Mesh-related outcomes

Mesh erosion

6

Mesh shrinkage

2

Degree of morbidity in mesh vs. native tissue

1

Cost/effectiveness

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

1

Rate of recruitment compliance

1

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

Forty-two randomised trials compared native tissue or biological graft versus mesh repair for anterior vaginal prolapse. Mesh-related complications were rarely reported: seven trials (9%) reported mesh erosion, six (7%) reported mesh shrinkage and a single trial (1%) reported the degree of morbidity associated with mess Only three trials (4%) evaluated cost effectiveness. One hundred and twelve different outcome measures wer reported (Table 4). Forty-six questionnaires were used as measurement instruments, most of which were validated (45; 98%). Anterior prolapse symptoms were measured using the Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire (PISQ-12) (13 trials; 16%), Urogenital Distress Inventory (UDI-6) (11 trials; 14%) and the Pelvic Floor Distress Inventory (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.
Table 4

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

Outcomes

No of reporting studies

Prolapse treatment success rate

Anatomical success rate POP-Q < 2

23

Anatomical success rate (POP-Q ≤ 1)

5

Anatomical success rate (postoperative POP-Q stage improvement)

5

Anatomical success rate (POP above hymen)

3

Anatomical success rate POP-Q ≤ 2

2

Anatomical success rate (POP-Q < 2 vs. POP-Q ≤ 1)

1

Anatomical success rate POP-Q Index (POP-Q-I) = 0

1

Anatomical success rate (postoperative POP-Q + BW stage improvement)

1

Anatomical success rate (cotton swab mobility test)

1

Composite success rate (POP-Q < 2 + UDI question 16 negative

1

Composite success rate (POP above hymen + VAS >20 (0–100 scale))

1

Composite success rate - (POP above hymen + no symptoms)

1

Composite success rate - (apex below levator plate + no symptoms)

1

Denovo POP in untreated compartments (POP-Q ≥ 2)

1

Denovo POP in untreated compartments (POP ≥ hymen)

1

Recurrence rate of POP (halfway BW stage change)

1

Perioperative complications and observations

 

Postoperative hospital stay length (days)

11

Blood loss (ml)

8

Duration of operation (min)

6

PONV (postoperative nausea and vomiting), visual analogue scale [VAS (0–10)]

2

PONV scale

2

PONV QoR (quality of recovery) score > 50

2

Recovery time (days)

2

PONV intensity score [QoR (0–40)]

1

Blood pressure (mmHg)

1

Heart rate (beats/min)

1

Consistency of bowel movement (Bristol stool scale)

1

Constipation perioperatively (Rome III constipation questionnaire)

1

Time to mobilisation (days)

1

Pain

VAS (0–10)

5

VAS (0–100)

2

VAS (not specified)

2

Mcgill pain questionnaire

2

Verbal numerical pain scale (0–10)

1

Baudelocque’s questionnaire

1

Nonvalidated questionnaire (0–3)

1

Postoperative catheterisation

Postoperative catheterisation duration (days)

4

Day of spontaneous voiding (days)

3

Bacterial count in the urine

1

Residual urine volume (ml)

1

First PVR (postvoid residual volume) > 150 ml

1

First PVR > 1500 ml

1

Mean residual urine volume pre- and postoperatively (ml)

1

Recatheterisation if PVR >200 ml

1

Prediction of voiding dysfunction >7 days (positive predictive value)

1

Diagnostic accuracy of two voiding trial methods (sensitivity/specificity)

1

Postoperative vaginal packing

Bleeding postoperatively (with/out vaginal pack use) (compared with menstrual average)

1

Bleeding postoperatively (with/out vaginal pack use) [FBC change and volume (ml)]

1

Blood pressure (mmHg)

1

Heart rate (beats/min)

1

Blood transfusion indicated (yes/no)

1

Vaginal haematoma (TVUSS)

1

Vaginal infection (HVS)

1

Bother related to the pack (VAS 0–100)

1

Presence of symptoms posttreatment

 

PISQ-12 (Pelvic Organ Prolapse Urinary Incontinence–Sexual Questionnaire)

13

UDI-6 (Urogenital Distress Inventory)

11

PFDI-20 (Pelvic Floor Distress Inventory)

9

SUI urodynamic studies

7

DDI (Defecatory Distress Inventory)

5

ICIQ-UI SF (International Consultation on Incontinence Questionnaire–Short Form)

4

SUI cough test (presence of leakage)

4

FSFI (Female Sexual Function Index)

2

ICIQ-BS (International Consultation on Incontinence Questionnaire–Bowel Symptoms)

2

PGI-I (Patient Global Impression of Improvement)

2

OAB-V8 (Overactive Bladder-Validated 8-question)

2

POPDI-6 (Pelvic Organ Prolapse Distress Inventory)

2

POP-SS (Pelvic Organ Prolapse Severity of Symptoms)

2

UDI-I (Urogenital Distress Inventory–Irritative)

2

UDI-O (Urogenital Distress Inventory-Obstructive)

2

UDI-S (Urogenital Distress Inventory–Stress)

2

AUASS [American Urological Association Symptom Score (urinary)]

1

CRADI-8 (Colorectal–Anal Distress Inventory)

1

CRAIQ-7 (Colorectal–Anal Impact Questionnaire)

1

Danish prolapse questionnaire

1

ICIQ-VS (International Consultation on Incontinence Questionnaire–Vaginal Symptoms)

1

MESAAQ (Medical Epidemiologic and Social Aspects of Ageing Questionnaire)

1

MHU (French Urinary Dysfunction Measurement Scale)

1

MSHQ (Male Sexual Health Questionnaire)

1

PGI-S (Patient Global Impression of Severity)

1

QS-F (Sexual Quotient–Female Version)

1

SUI number of daily pads

1

Impact on quality of life

P-QoL (Prolapse Quality of Life)

10

PFIQ-7 (Pelvic Floor Impact Questionnaire–Short Form)

8

IIQ-7 (Incontinence Impact Questionnaire–Short Form)

6

ICIQ-UI SF (International Consultation on Incontinence Questionnaire–Urinary Symptoms)

4

ICIQ-VS (International Consultation on Incontinence Questionnaire–Vaginal Symptoms)

3

KHQ (King’s Health Questionnaire)

3

UIQ-7 (Urogenital Impact Questionnaire)

3

DDI (Defecatory Distress Inventory)

2

EQ5D [Quality of Life (EuroQol)]

2

POPIQ-7 (Pelvic Floor Impact Questionnaire–Prolapse)

2

VAS (0–10)

2

CRAIQ-7 (Colorectal–Anal Impact Questionnaire)

1

PSI-QOL (Prolapse Symptom Inventory and Quality of Life Questionnaire)

1

SF-12 (12-Item Short-Form Health Survey)

1

SF-36 (36-Item Short-Form Health Survey)

1

Satisfaction

Patient satisfaction with treatment, VAS (0–10)

3

Patient satisfaction with treatment, PGI (Patient Global Improvement)

3

Patient satisfaction with treatment (yes/no)

3

Patient satisfaction with treatment, VAS (0–100)

2

Patient satisfaction with treatment, VAS (0–4)

1

Patient satisfaction with treatment, custom (0–5)

1

Patient acceptability of preoperative bowel preparation, VAS) (0–4)

1

Surgeon satisfaction with preoperative bowel preparation, Likert scale (0–4)

1

Surgeon ease to perform operation, Likert scale (0–4)

1

Surgeon’s satisfaction with operation, VAS (0–100)

1

Cost/effectiveness

Incremental cost per quality-adjusted life-year (QALY)

2

Cost of procedure (US$)

1

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

Table 5

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

Study

Sample size (N)

Outcomes

Anatomical prolapse stage

Quality of life and impact from symptoms

Complications intra-/postoperatively

Sexual dysfunction symptoms

Postoperative hospital stay length

Urinary symptoms

Patient satisfaction with treatment

Prolapse symptoms postoperatively

Postoperative pain

Glazener et al.

1352

x

 

x

x

 

x

x

x

 

Altman et al.

389

x

 

x

x

     

Wei et al.

337

 

x

x

      

Weemhoff et al.

246

    

x

    

Nieminen et al.

203

   

x

   

x

 

Hiltunen et al.

202

x

 

x

      

Farthmann et al.

200

x

     

x

 

x

Kamilya et al.

200

    

x

    

Withagen et al.

194

x

x

x

 

x

   

x

Natale et al.

190

x

x

       

Thiagamoorthy et al.

190

        

x

da Silveira et al.

184

x

  

x

     

Borstad et al.

184

x

        

Van et al.

179

    

x

    

Sand et al.

161

x

        

Rudnicki et al.

160

x

x

x

      

Gandhi et al.

154

x

        

Ballard et al.

150

      

x

  

de Tayrac et al.

147

x

 

x

   

x

  

Carey et al.

139

x

x

x

   

x

  

Rudnicki et al.

138

x

        

Dahlgren et al.

135

x

  

x

 

x

 

x

 

Stekkinger et al.

126

    

x

    

Vollebregt et al.

125

x

x

x

x

     

Qatawneh et al.

116

x

 

x

   

x

x

 

Weber et al.

114

x

 

x

      

Chmielewski et al.

114

x

        

Gupta et al.

106

x

 

x

      

Tamanini et al.

100

x

x

 

x

   

x

 

Hakvoort

100

    

x

    

Menefee et al.

99

x

x

 

x

   

x

 

Ek et al.

99

x

        

Guerette et al.

94

x

x

 

x

 

x

   

Westermann et al.

93

      

x

 

x

Studies not included

<93

19

16

11

5

5

8

4

3

4

Total studies

 

43

25

23

14

11

11

11

9

8

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).
Table 6

Univariate and multivariate correlation with outcome reporting quality

Factor

Univariate

Multivariate

Spearman’s rho

P value

Beta

P value

Study quality (Jadad)

00.409

<0.001

0.412

0.018

Journal IF

0.053

0.643

0.078

0.306

Year of publication

0.458

<0.001

0.149

0.295

Study size

0.215

0.051

0.008

0.961

Journal type

0.024

0.852

Commercial funding

−0.013

0.918

Validated questionnaire

1.310

0.196

Bolded data statistically significant

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.

Strengths and limitations

Strengths of our systematic review include originality, a rigorous search strategy and methodological robustness. To our knowledge, this systematic review is the first to evaluate outcomes and outcome measures in anterior-compartment prolapse trials. Study screening and selection and data extraction and assessment were conducted independently by two researchers to avoid bias. Our findings were based on outcome reporting in published randomised trials. The exclusion of observational studies may have potentially missed outcomes related to harm [89, 90] and selecting only trials reported in English may have introduced selection bias. The variation of interventions for correcting anterior prolapse may have caused variation in outcome and outcome-measure reporting.

Interpretation

Randomised trials require a substantial investment of resources. Variation in outcomes and outcome measures limits the ability of trials to be combined with meta-analyses, which contributes to inevitable research waste, as identified in various areas of women’s health, including childbirth trauma, endometriosis and pre-eclampsia [91, 92, 93, 94]. This systematic review is the first step in the development of a minimum data set, which will be known as a core outcome set. It will be developed with reference to methods described by the COMET initiative, Core Outcomes in Women’s and Newborn Health (CROWN) initiative and other core-outcome-set development studies, including those on endometriosis, pre-eclampsia, termination of pregnancy, Twin-Twin Transfusion Syndrome and neonatal medicine [95, 96, 97, 98, 99].

CHORUS is aiming to work towards a standardisation of outcomes and outcome measures and subsequently establish a minimum of standards in research and clinical practice. Chorus working groups are currently evaluating reported outcomes in all areas of urogyneacology and have been registered with the COMET (registration number 981, http://www.comet-initiative.org/studies/details/981) and CROWN initiatives. Each working group has carefully considered the scope of its work [100], and CHORUS will replicate the success of other international initiatives that have standardised outcome selection, collection and reporting across preterm birth research [101].

In the absence of a core outcome, we recommend QoL (incorporating sexual function), postoperative complications, patient and physician satisfaction and postoperative prolapse, bladder and bowel symptoms be collected across all anterior prolapse trials.

Conclusion

Anterior-compartment 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.

Notes

Compliance with ethical standards

Conflicts of interest

The authors report that they have no conflicts of interest.

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© The Author(s) 2018

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Authors and Affiliations

  • 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
  1. 1.Department of Obstetrics and GynaecologyEpsom and St Helier University Hospitals NHS TrustLondonUK
  2. 2.Nortwick Park HospitalLondon North West University Healthcare NHS TrustLondonUK
  3. 3.Laboratory of Experimental Surgery and Surgical Research N.S. ChristeasAthens University Medical SchoolAthensGreece
  4. 4.Nuffield Department of Primary Care Health SciencesUniversity of OxfordOxfordUK
  5. 5.Balliol CollegeUniversity of OxfordOxfordUK
  6. 6.St George’s University of LondonLondonUK

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