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Cochrane Database of Systematic Reviews

Malla o injertos transvaginales comparados con reparación con tejido autólogo para el prolapso vaginal

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Información

DOI:
https://doi.org/10.1002/14651858.CD012079Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 09 febrero 2016see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Ginecología y fertilidad

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Christopher Maher

    Correspondencia a: Royal Brisbane and Women's Hospital, Brisbane, Australia

    [email protected]

  • Benjamin Feiner

    Department of Urogynecology & Reconstructive Pelvic Surgery, Hillel Yaffe Medical Center, Technion University, Hadera, Israel

  • Kaven Baessler

    Urogynaecology Department, Pelvic Floor Centre Charite, Berlin, Germany

  • Corina Christmann‐Schmid

    New Women's Clinic, Lucerne Cantonal Hospital, Lucerne, Switzerland

  • Nir Haya

    Department of Obstetrics and Gynaecology, Lady Davis Carmel Medical Center, and the Ruth and Bruce Rappaport School of Medicine, Technion‐Israel Institute of Technology, Haifa, Israel

  • Jane Marjoribanks

    Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand

Contributions of authors

All review authors contributed to writing the protocol. Four review authors (C Maher, C Schmid, B Feiner, K Baessler) assessed the relevance and eligibility of studies for inclusion in the review and then assessed the quality of included studies. Four review authors (C Maher, C Schmid, K Baessler, B Feiner) independently extracted data from trial reports, interpreted the results, and contributed to the writing of the draft version of the review.

Sources of support

Internal sources

  • Cochrane, UK.

    Cochrane Review Support Programme: Pelvic organ prolapse reviews

External sources

  • National Institute for Health Research (NIHR), UK.

    This project was supported by the NIHR, via Cochrane Infrastructure funding to the Cochrane Incontinence Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, the NIHR, the NHS or the Department of Health.

Declarations of interest

The lead review author, Christopher Maher, is an author of two trials of pelvic prolapse (Maher 2004a; Maher 2011)

The other review authors declare that they have no conflicts of interest.

Acknowledgements

We acknowledge the work of Elisabeth J Adams and Suzanne Hagen as coauthors on the original review, and Charis Glazener as coauthor on the original review and update. The authors of the 2016 update would like to thank Sheila Wallace, Information Specialist of the Cochrane Incontinence Review Group, for designing the search strategy and running the searches for this review. We are also grateful for the assistance of Helen Nagels and Cindy Farquhar of the Cochrane Gynaecology and Fertility Group in the preparation of this new review.

Version history

Published

Title

Stage

Authors

Version

2024 Mar 13

Transvaginal mesh or grafts or native tissue repair for vaginal prolapse

Review

Ellen Yeung, Kaven Baessler, Corina Christmann-Schmid, Nir Haya, Zhuoran Chen, Sheila A Wallace, Alex Mowat, Christopher Maher

https://doi.org/10.1002/14651858.CD012079.pub2

2016 Feb 09

Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse

Review

Christopher Maher, Benjamin Feiner, Kaven Baessler, Corina Christmann‐Schmid, Nir Haya, Jane Marjoribanks

https://doi.org/10.1002/14651858.CD012079

Differences between protocol and review

This review is the result of updating the review 'Surgical management of pelvic organ prolapse in women'. As a result of the update, we decided to split the review into six reviews.

This review should be read as part of a series of six Cochrane reviews relating to the surgical management of prolapse including:

  1. Surgery for women with anterior compartment prolapse.

  2. Surgery for women with posterior compartment prolapse.

  3. Surgery for women with apical compartment prolapse.

  4. Continence outcomes in pelvic organ prolapse surgery.

  5. Transvaginal grafts or mesh compared with native tissue repair for vaginal prolapse.

  6. Perioperative interventions at prolapse surgery.

Differences from the published review methods were a reduction in the number of outcomes and limiting this review to studies that compared native tissue with mesh (absorbable and permanent) and biological grafts.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

PRISMA study flow diagram.
Figuras y tablas -
Figure 1

PRISMA study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Forest plot of comparison: 1 Any transvaginal permanent mesh versus native tissue repair, outcome: 1.1 Awareness of prolapse (1 to 3 years).
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Any transvaginal permanent mesh versus native tissue repair, outcome: 1.1 Awareness of prolapse (1 to 3 years).

Forest plot of comparison: 3 Biological repair versus native tissue repair, outcome: 3.1 Awareness of prolapse (1 to 3 years).
Figuras y tablas -
Figure 5

Forest plot of comparison: 3 Biological repair versus native tissue repair, outcome: 3.1 Awareness of prolapse (1 to 3 years).

Funnel plot of comparison: 1 Any transvaginal permanent mesh versus native tissue repair, outcome: 1.3 Recurrent prolapse (any) at 1 to 3 years.
Figuras y tablas -
Figure 6

Funnel plot of comparison: 1 Any transvaginal permanent mesh versus native tissue repair, outcome: 1.3 Recurrent prolapse (any) at 1 to 3 years.

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 1 Awareness of prolapse (1‐3 years).
Figuras y tablas -
Analysis 1.1

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 1 Awareness of prolapse (1‐3 years).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 2 Repeat surgery (1‐3 years).
Figuras y tablas -
Analysis 1.2

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 2 Repeat surgery (1‐3 years).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 3 Recurrent prolapse (any) at 1‐3 years.
Figuras y tablas -
Analysis 1.3

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 3 Recurrent prolapse (any) at 1‐3 years.

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 4 Injuries bladder or bowel.
Figuras y tablas -
Analysis 1.4

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 4 Injuries bladder or bowel.

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocoele).
Figuras y tablas -
Analysis 1.5

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocoele).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocoele).
Figuras y tablas -
Analysis 1.6

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocoele).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 7 POPQ assessment (any mesh).
Figuras y tablas -
Analysis 1.7

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 7 POPQ assessment (any mesh).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 8 Bladder function: de novo stress urinary incontinence (1‐3 years).
Figuras y tablas -
Analysis 1.8

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 8 Bladder function: de novo stress urinary incontinence (1‐3 years).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 9 De novo voiding disorder, urgency, detrusor overactivity or overactive bladder.
Figuras y tablas -
Analysis 1.9

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 9 De novo voiding disorder, urgency, detrusor overactivity or overactive bladder.

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 10 De novo dyspareunia (1‐3 years).
Figuras y tablas -
Analysis 1.10

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 10 De novo dyspareunia (1‐3 years).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 11 Sexual function (1‐3 years).
Figuras y tablas -
Analysis 1.11

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 11 Sexual function (1‐3 years).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 12 Quality of life: continuous data (1‐2 years):.
Figuras y tablas -
Analysis 1.12

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 12 Quality of life: continuous data (1‐2 years):.

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 13 Quality of life: dichotomous data "much or very much better".
Figuras y tablas -
Analysis 1.13

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 13 Quality of life: dichotomous data "much or very much better".

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 14 Operating time (minutes).
Figuras y tablas -
Analysis 1.14

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 14 Operating time (minutes).

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 15 Blood transfusion.
Figuras y tablas -
Analysis 1.15

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 15 Blood transfusion.

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 16 Length of stay in hospital (days).
Figuras y tablas -
Analysis 1.16

Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 16 Length of stay in hospital (days).

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 1 Awareness of prolapse (2 year review).
Figuras y tablas -
Analysis 2.1

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 1 Awareness of prolapse (2 year review).

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 2 Repeat surgery for prolapse (2 years).
Figuras y tablas -
Analysis 2.2

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 2 Repeat surgery for prolapse (2 years).

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 3 Recurrent prolapse (3 months ‐2 years).
Figuras y tablas -
Analysis 2.3

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 3 Recurrent prolapse (3 months ‐2 years).

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 4 Death.
Figuras y tablas -
Analysis 2.4

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 4 Death.

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocoele).
Figuras y tablas -
Analysis 2.5

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocoele).

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocoele).
Figuras y tablas -
Analysis 2.6

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocoele).

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 7 Stress urinary incontinence.
Figuras y tablas -
Analysis 2.7

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 7 Stress urinary incontinence.

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 8 Quality of life (2 years).
Figuras y tablas -
Analysis 2.8

Comparison 2 Absorbable mesh versus native tissue repair, Outcome 8 Quality of life (2 years).

Comparison 3 Biological repair versus native tissue repair, Outcome 1 Awareness of prolapse (1‐3 year).
Figuras y tablas -
Analysis 3.1

Comparison 3 Biological repair versus native tissue repair, Outcome 1 Awareness of prolapse (1‐3 year).

Comparison 3 Biological repair versus native tissue repair, Outcome 2 Repeat prolapse surgery (1‐2 years).
Figuras y tablas -
Analysis 3.2

Comparison 3 Biological repair versus native tissue repair, Outcome 2 Repeat prolapse surgery (1‐2 years).

Comparison 3 Biological repair versus native tissue repair, Outcome 3 Recurrent prolapse (1 year).
Figuras y tablas -
Analysis 3.3

Comparison 3 Biological repair versus native tissue repair, Outcome 3 Recurrent prolapse (1 year).

Comparison 3 Biological repair versus native tissue repair, Outcome 4 Injuries to bladder or bowel.
Figuras y tablas -
Analysis 3.4

Comparison 3 Biological repair versus native tissue repair, Outcome 4 Injuries to bladder or bowel.

Comparison 3 Biological repair versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocele).
Figuras y tablas -
Analysis 3.5

Comparison 3 Biological repair versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocele).

Comparison 3 Biological repair versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocele).
Figuras y tablas -
Analysis 3.6

Comparison 3 Biological repair versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocele).

Comparison 3 Biological repair versus native tissue repair, Outcome 7 POPQ assessment.
Figuras y tablas -
Analysis 3.7

Comparison 3 Biological repair versus native tissue repair, Outcome 7 POPQ assessment.

Comparison 3 Biological repair versus native tissue repair, Outcome 8 De novo urinary stress incontinence.
Figuras y tablas -
Analysis 3.8

Comparison 3 Biological repair versus native tissue repair, Outcome 8 De novo urinary stress incontinence.

Comparison 3 Biological repair versus native tissue repair, Outcome 9 De novo voiding disorders, urgency, detrusor overactivity or overactive bladder.
Figuras y tablas -
Analysis 3.9

Comparison 3 Biological repair versus native tissue repair, Outcome 9 De novo voiding disorders, urgency, detrusor overactivity or overactive bladder.

Comparison 3 Biological repair versus native tissue repair, Outcome 10 De novo dyspareunia (1 year).
Figuras y tablas -
Analysis 3.10

Comparison 3 Biological repair versus native tissue repair, Outcome 10 De novo dyspareunia (1 year).

Comparison 3 Biological repair versus native tissue repair, Outcome 11 Sexual function (1 year).
Figuras y tablas -
Analysis 3.11

Comparison 3 Biological repair versus native tissue repair, Outcome 11 Sexual function (1 year).

Comparison 3 Biological repair versus native tissue repair, Outcome 12 Quality of life (1 year).
Figuras y tablas -
Analysis 3.12

Comparison 3 Biological repair versus native tissue repair, Outcome 12 Quality of life (1 year).

Comparison 3 Biological repair versus native tissue repair, Outcome 13 Operating time (minutes).
Figuras y tablas -
Analysis 3.13

Comparison 3 Biological repair versus native tissue repair, Outcome 13 Operating time (minutes).

Comparison 3 Biological repair versus native tissue repair, Outcome 14 Blood transfusion.
Figuras y tablas -
Analysis 3.14

Comparison 3 Biological repair versus native tissue repair, Outcome 14 Blood transfusion.

Summary of findings for the main comparison. Any transvaginal permanent mesh versus native tissue repair for vaginal prolapse

Any transvaginal permanent mesh versus native tissue repair for vaginal prolapse

Population: women with vaginal prolapse
Settings: surgical
Intervention: any transvaginal permanent mesh versus native tissue repair

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Native tissue repair

Any transvaginal permanent mesh

Awareness of prolapse

review 1 to 3 years

188 per 1000

124 per 1000
(101 to 152)

RR 0.66

(0.54 to 0.81)

1614

(12 RCTs)

⊕⊕⊕⊝
moderate1

Repeat surgery ‐ prolapse

review 1 to 3 years

32 per 1000

17 per 1000
(10 to 28)

RR 0.53
(0.31 to 0.88)

1675
(12 RCTs)

⊕⊕⊕⊝
moderate1

Repeat surgery ‐ continence surgery

26 per 1000

28 per 1000

(16 to 48)

RR 1.07

(0.62 to 1.83)

1284

(9 RCTs)

⊕⊕⊝⊝
low1,2

Repeat surgery ‐ surgery for prolapse, SUI, or mesh exposure

review 1 to 3 years

48 per 1000

114 per 1000
(72 to 181)

RR 2.40
(1.51 to 3.81)

867
(7 studies)

⊕⊕⊕⊝
moderate1

Recurrent prolapse

review 1 to 3 years

381 per 1000

152 per 1000
(114 to 202)

RR 0.40
(0.30 to 0.53)

2494
(21 studies)

⊕⊕⊝⊝
low1,4

I2 = 73%

Bladder injury

5 per 1000

21 per 1000
(9 to 51)

RR 3.92
(1.62 to 9.5)

1514
(11 studies)

⊕⊕⊕⊝
moderate1

De novo dyspareunia (pain during sexual intercourse)

review 1 to 3 years

95 per 1000

88 per 1000
(55 to 140)

RR 0.92
(0.58 to 1.47)

764
(11 studies)

⊕⊕⊝⊝
low1,2

De novo stress urinary

incontinence review 1 to 3 years

96 per 1000

133 per 1000
(101 to 174)

RR 1.39
(1.06 to 1.82)

1512
(12 studies)

⊕⊕⊝⊝
low1,3

Quality of life

review 1 to 2 years

The mean quality of life in the mesh groups was 0.05 standard deviations higher (0.20 lower to 0.30 higher). This is an imprecise finding that is consistent with a small benefit in either group, or else no difference between the groups

665

(7 studies)

⊕⊝⊝⊝

very low1, 2,4

I2 = 60%

*The basis for the assumed risk is the median control group risk across studies The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio; SUI: stress urinary incontinence

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded one level due to serious risk of bias: most of the studies were at unclear or high risk of bias associated with poor reporting of methods, including failure by many to describe satisfactory methods of allocation concealment or blinding. A minority of studies did not report use of blinding at all.

2Downgraded one level due to serious imprecision: findings compatible with benefit in either group or with no clinically meaningful difference between the groups.

3Downgraded one level due to serious imprecision: findings compatible with benefit in native tissue group or with no clinically meaningful difference between the groups.

4Downgraded one level due to serious inconsistency: substantial statistical heterogeneity.

Figuras y tablas -
Summary of findings for the main comparison. Any transvaginal permanent mesh versus native tissue repair for vaginal prolapse
Summary of findings 2. Absorbable mesh versus native tissue repair for vaginal prolapse

Absorbable mesh versus native tissue repair for vaginal prolapse

Population: women with vaginal prolapse
Settings: surgical
Intervention: absorbable mesh

Control: native tissue repair

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Native tissue repair

Absorbable mesh

Awareness of prolapse

at 2 years

724 per 1000

760 per 1000
(558 to 1000)

RR 1.05
(0.77 to 1.44)

54
(1 study)

⊕⊝⊝⊝
very low1,2

Repeat surgery for prolapse (stage 2 or more)

at 2 years

125 per 1000

59 per 1000
(11 to 300)

RR 0.47
(0.09 to 2.40)

66
(1 study)

⊕⊝⊝⊝
very low1,2

Recurrent prolapse

at 3 months to 2 years

429 per 1000

304 per 1000
(223 to 411)

RR 0.71
(0.52 to 0.96)

292
(3 studies)

⊕⊕⊝⊝
low3,4

Bladder injury

Not reported in the included studies

De novo dyspareunia (pain during sexual intercourse)

review 1 to 3 years

Not reported in the included studies

Stress urinary incontinence

at 2 years

593 per 1000

818 per 1000
(563 to 1000)

RR 1.38
(0.95 to 2)

49
(1 study)

⊕⊝⊝⊝
very low1,2

Quality of life

at 2 years

The mean quality of life score was the same in both groups, when measured using a severity score of 1 to 10 (mean difference 0, 95% CI ‐2.82 to 2.82)

54
(1 study)

⊕⊝⊝⊝
very low1,2

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded one level due to serious risk of attrition bias: at two years 18% not included in analysis.
2Downgraded two levels due to very serious imprecision: single small trial with confidence interval compatible with benefit in either arm or no effect. Low event rate.
3Downgraded one level due to serious risk of attrition bias in 2/3 studies.
4Downgraded one level due to serious imprecision: low overall event rate (n = 101).
5Downgraded one level due to serious risk of bias: unclear whether outcome assessment was blinded.

Figuras y tablas -
Summary of findings 2. Absorbable mesh versus native tissue repair for vaginal prolapse
Summary of findings 3. Biological repair versus native tissue repair for vaginal prolapse

Biological repair versus native tissue repair for vaginal prolapse

Population: women with vaginal prolapse
Settings: surgical
Intervention: biological repair

Control: native tissue repair

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Native tissue repair

Biological repair

Awareness of prolapse

at 1 to 3 years

105 per 1000

102 per 1000
(68 to 151)

RR 0.97
(0.65 to 1.43)

777
(7 studies)

⊕⊕⊝⊝
low1,2

Repeat prolapse surgery

1 to 2 years

43 per 1000

52 per 1000
(26 to 105)

RR 1.22
(0.61 to 2.44)

306
(5 studies)

⊕⊕⊝⊝
low3,4

Recurrent prolapse

at 1 year

295 per 1000

277 per 1000
(177 to 434)

RR 0.94
(0.60 to 1.47)

587
(7 studies)

⊕⊝⊝⊝
very low3,5,6

Bladder injury

Not estimable as only 1 event occurred (in the native tissue group)

137

(1 study)

Bowel injury

Not estimable as only 1 event occurred (in the biological repair group)

137

(1 study)

De novo dyspareunia (pain during sexual intercourse)

review 1 to 3 years

177 per 1000

150 per 1000
(35 to 648)

RR 0.85
(0.20 to 3.67)

37
(1 study)

⊕⊝⊝⊝
very low3,8

De novo urinary stress incontinence

at 1 year

Not estimable ‐ no events occurred

56
(1 study)

Quality of life

at 1 year

The mean quality of life in the biological repair group was 0.05 standard deviations lower (0.48 lower to 0.38 higher). This is an imprecise finding that is consistent with a small benefit in either group, or else no difference between the groups

84
(2 studies)

⊕⊝⊝⊝
very low9

*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded one level due to serious risk of bias: four of the studies at high or unclear risk of bias associated with blinding status.
2Downgraded one level due to serious imprecision: confidence intervals compatible with benefit in either group or with no difference between the groups.
3Downgraded one level due to imprecision: confidence interval compatible with benefit in either group or with no difference between groups.
4Downgraded one level due to serious risk of bias in 3/5 studies: two studies at high risk of attrition bias, and one study not blinded.
5Downgraded one level due to serious risk of bias: three studies rated at high risk of attrition bias, detection bias, and other bias (conflict of interest), respectively.
6Downgraded one level due to serious inconsistency: I2 = 59% indicating substantial statistical heterogeneity.

7Downgraded one level due to serious risk of bias: blinding status unclear.

8Downgraded two levels due to very serious imprecision: single small study, only six events.

9Downgraded one level due to serious risk of attrition bias, and a further two levels due to very serious imprecision: only 84 participants.

Figuras y tablas -
Summary of findings 3. Biological repair versus native tissue repair for vaginal prolapse
Table 1. Mesh exposure following transvaginal permanent mesh

Study ID

Repair events

Repair total

Exposure events

Exposure total

Ali 2006 abstract

0

43

3

46

Al‐Nazer 2007

0

23

1

21

Altman 2011

0

182

21

183

Carey 2009

0

60

5

62

da Silveira 2014

0

81

18

88

Delroy 2013

0

39

2

40

Gupta 2014

0

54

4

44

Halaska 2012

0

72

16

79

Iglesia 2010

0

33

5

32

Lamblin 2014

0

35

2

33

Menefee 2011

0

24

2

28

Nguyen 2008

0

38

2

37

Nieminen 2008

0

96

18

104

Qatawneh 2013

0

63

4

53

Sivaslioglu 2008

0

42

3

43

Thijs 2010 abstract

0

48

9

48

Turgal 2013

0

20

3

20

Vollebregt 2011

0

51

2

53

Withagen 2011

0

84

14

83

Total

134

1097

Figuras y tablas -
Table 1. Mesh exposure following transvaginal permanent mesh
Table 2. Mesh exposure versus anterior compartment repairs

Study ID

Repair events

Repair total

Exposure events

Exposure total

Ali 2006 abstract

0

43

3

46

Al‐Nazer 2007

0

23

1

21

Altman 2011

0

182

21

183

Delroy 2013

0

39

2

40

Gupta 2014

0

54

4

44

Lamblin 2014

0

35

2

33

Menefee 2011

0

24

2

28

Nguyen 2008

0

38

2

37

Nieminen 2008

0

96

18

104

Qatawneh 2013

0

63

4

53

Sivaslioglu 2008

0

42

3

43

Thijs 2010 abstract

0

48

9

48

Turgal 2013

0

20

3

20

Vollebregt 2011

0

51

2

53

Total

76

753

Figuras y tablas -
Table 2. Mesh exposure versus anterior compartment repairs
Table 3. Mesh exposure versus multi‐compartment repairs

Study ID

Repair events

Repair total

Exposure events

Exposure total

Carey 2009

0

60

5

62

da Silveira 2014

0

81

18

88

Halaska 2012

0

72

16

79

Iglesia 2010

0

33

5

32

Withagen 2011

0

84

14

83

Total

58

344

Figuras y tablas -
Table 3. Mesh exposure versus multi‐compartment repairs
Table 4. Surgery for mesh exposure following any transvaginal permanent mesh

Study ID

Surgery for mesh exposure

Total number of women in mesh group

Altman 2011

6

186

Carey 2009

3

62

da Silveira 2014

7

88

De Tayrac 2013

4

66

Delroy 2013

2

40

Gupta 2014

2

44

Halaska 2012

10

79

Iglesia 2010

3

32

Lamblin 2014

2

33

Nguyen 2008

2

37

Nieminen 2008

14

104

Qatawneh 2013

4

53

Rudnicki 2014

5

78

Sivaslioglu 2008

3

43

Svabik 2014

2

36

Tamanini 2014

7

42

Thijs 2010 abstract

4

48

Turgal 2013

3

20

Vollebregt 2011

2

53

Withagen 2011

5

83

Total

100

1227

Figuras y tablas -
Table 4. Surgery for mesh exposure following any transvaginal permanent mesh
Comparison 1. Any transvaginal permanent mesh versus native tissue repair

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse (1‐3 years) Show forest plot

12

1614

Risk Ratio (M‐H, Fixed, 95% CI)

0.66 [0.54, 0.81]

1.1 Anterior compartment:mesh vs native tissue

9

1172

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.51, 0.84]

1.2 Multicompartment: mesh vs native tissue

4

442

Risk Ratio (M‐H, Fixed, 95% CI)

0.67 [0.46, 0.97]

2 Repeat surgery (1‐3 years) Show forest plot

14

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Prolapse

12

1675

Risk Ratio (M‐H, Fixed, 95% CI)

0.53 [0.31, 0.88]

2.2 Continence surgery

9

1284

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.62, 1.83]

2.3 Surgery for prolapse, SUI or mesh exposure

7

867

Risk Ratio (M‐H, Fixed, 95% CI)

2.40 [1.51, 3.81]

3 Recurrent prolapse (any) at 1‐3 years Show forest plot

21

2494

Risk Ratio (M‐H, Random, 95% CI)

0.40 [0.30, 0.53]

3.1 Anterior compartment repair: mesh versus native tissue

15

1748

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.26, 0.40]

3.2 Multi‐compartment repair: mesh versus native tissue

6

746

Risk Ratio (M‐H, Random, 95% CI)

0.59 [0.40, 0.87]

4 Injuries bladder or bowel Show forest plot

11

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Bladder injury

11

1514

Risk Ratio (M‐H, Fixed, 95% CI)

3.92 [1.62, 9.50]

4.2 Bowel injury

1

169

Risk Ratio (M‐H, Fixed, 95% CI)

3.26 [0.13, 78.81]

5 Objective failure of anterior compartment (cystocoele) Show forest plot

13

1406

Risk Ratio (M‐H, Fixed, 95% CI)

0.45 [0.36, 0.55]

5.1 Anterior compartment repair: mesh versus native tissue

9

1004

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.28, 0.47]

5.2 Multi‐compartment repair: mesh versus native tissue

4

402

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.51, 1.06]

6 Objective failure of posterior compartment (rectocoele) Show forest plot

3

226

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.29, 1.42]

6.1 Mesh vs native tissue

3

226

Risk Ratio (M‐H, Fixed, 95% CI)

0.64 [0.29, 1.42]

7 POPQ assessment (any mesh) Show forest plot

10

Mean Difference (IV, Random, 95% CI)

Subtotals only

7.1 Point Ba POPQ

10

1125

Mean Difference (IV, Random, 95% CI)

‐0.93 [‐1.27, ‐0.59]

7.2 Point C POPQ

8

925

Mean Difference (IV, Random, 95% CI)

‐0.45 [‐1.13, 0.23]

7.3 Point Bp

7

832

Mean Difference (IV, Random, 95% CI)

0.05 [‐0.34, 0.44]

7.4 total vaginal length

5

611

Mean Difference (IV, Random, 95% CI)

0.07 [‐0.25, 0.40]

8 Bladder function: de novo stress urinary incontinence (1‐3 years) Show forest plot

12

1512

Risk Ratio (M‐H, Fixed, 95% CI)

1.39 [1.06, 1.82]

8.1 Anterior compartment: mesh vs native tissue

8

1205

Risk Ratio (M‐H, Fixed, 95% CI)

1.45 [1.00, 2.11]

8.2 Multi compartment : mesh vs native tissue

4

307

Risk Ratio (M‐H, Fixed, 95% CI)

1.31 [0.90, 1.92]

9 De novo voiding disorder, urgency, detrusor overactivity or overactive bladder Show forest plot

3

236

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.35, 1.63]

10 De novo dyspareunia (1‐3 years) Show forest plot

11

764

Risk Ratio (M‐H, Fixed, 95% CI)

0.92 [0.58, 1.47]

10.1 Anterior compartment: mesh vs native tissue

8

643

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.60, 1.93]

10.2 Multicompartment: mesh vs native tissue

3

121

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.29, 1.42]

11 Sexual function (1‐3 years) Show forest plot

7

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

11.1 PISQ score

7

857

Mean Difference (IV, Fixed, 95% CI)

‐0.13 [‐0.40, 0.13]

12 Quality of life: continuous data (1‐2 years): Show forest plot

7

665

Std. Mean Difference (IV, Random, 95% CI)

0.05 [‐0.20, 0.30]

12.1 PQOL end score

3

331

Std. Mean Difference (IV, Random, 95% CI)

0.09 [‐0.31, 0.49]

12.2 Pelvic floor impact questionnaire end score

4

334

Std. Mean Difference (IV, Random, 95% CI)

0.02 [‐0.34, 0.37]

13 Quality of life: dichotomous data "much or very much better" Show forest plot

1

168

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.80, 1.25]

13.1 PGI‐I

1

168

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.80, 1.25]

14 Operating time (minutes) Show forest plot

13

Mean Difference (IV, Random, 95% CI)

Totals not selected

14.1 Anterior compartment: mesh vs native tissue

10

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14.2 Multicompartment: mesh vs native tissue

3

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

15 Blood transfusion Show forest plot

6

723

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [0.88, 2.72]

16 Length of stay in hospital (days) Show forest plot

7

953

Mean Difference (IV, Random, 95% CI)

‐0.06 [‐0.30, 0.18]

Figuras y tablas -
Comparison 1. Any transvaginal permanent mesh versus native tissue repair
Comparison 2. Absorbable mesh versus native tissue repair

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse (2 year review) Show forest plot

1

54

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.77, 1.44]

2 Repeat surgery for prolapse (2 years) Show forest plot

1

66

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.09, 2.40]

3 Recurrent prolapse (3 months ‐2 years) Show forest plot

3

292

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.52, 0.96]

3.1 Any site stage 2 or more

1

66

Risk Ratio (M‐H, Fixed, 95% CI)

0.53 [0.10, 2.70]

3.2 Anterior compartment

2

226

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.53, 0.98]

4 Death Show forest plot

2

175

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.1 absorbable mesh versus native tissue repair

2

175

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Objective failure of anterior compartment (cystocoele) Show forest plot

2

226

Risk Ratio (M‐H, Fixed, 95% CI)

0.72 [0.53, 0.98]

5.1 Anterior compartment repair: absorbable mesh versus native tissue

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.62, 1.34]

5.2 Multi‐compartment repair: absorbable mesh versus native tissue

1

143

Risk Ratio (M‐H, Fixed, 95% CI)

0.58 [0.35, 0.93]

6 Objective failure of posterior compartment (rectocoele) Show forest plot

1

132

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.40, 3.19]

6.1 Multi‐compartment repair: absorbable mesh versus native tissue

1

132

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.40, 3.19]

7 Stress urinary incontinence Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

7.1 Postoperative SUI

1

49

Risk Ratio (M‐H, Fixed, 95% CI)

1.38 [0.95, 2.00]

8 Quality of life (2 years) Show forest plot

1

54

Mean Difference (IV, Fixed, 95% CI)

0.0 [‐2.82, 2.82]

8.1 VAS QoL

1

54

Mean Difference (IV, Fixed, 95% CI)

0.0 [‐2.82, 2.82]

Figuras y tablas -
Comparison 2. Absorbable mesh versus native tissue repair
Comparison 3. Biological repair versus native tissue repair

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Awareness of prolapse (1‐3 year) Show forest plot

7

777

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.65, 1.43]

1.1 Anterior compartment repair: biological graft vs native tissue

4

429

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.45, 1.23]

1.2 Multicompartment repair: biological graft vs native tissue

1

126

Risk Ratio (M‐H, Fixed, 95% CI)

4.55 [1.04, 19.92]

1.3 Posterior compartment repair: biological graft vs native tissue

2

222

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.41, 1.94]

2 Repeat prolapse surgery (1‐2 years) Show forest plot

5

306

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.61, 2.44]

3 Recurrent prolapse (1 year) Show forest plot

7

587

Risk Ratio (M‐H, Random, 95% CI)

0.94 [0.60, 1.47]

3.1 Anterior compartment repair: biological graft vs native tissue

5

369

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.54, 1.05]

3.2 Posterior compartment repair: biological graft vs native tissue

2

218

Risk Ratio (M‐H, Random, 95% CI)

2.09 [1.18, 3.70]

4 Injuries to bladder or bowel Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 bladder injury

1

137

Risk Ratio (M‐H, Fixed, 95% CI)

0.35 [0.01, 8.40]

4.2 bowel injury

1

137

Risk Ratio (M‐H, Fixed, 95% CI)

3.13 [0.13, 75.57]

5 Objective failure of anterior compartment (cystocele) Show forest plot

6

570

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.46, 0.96]

6 Objective failure of posterior compartment (rectocele) Show forest plot

3

283

Risk Ratio (M‐H, Random, 95% CI)

1.16 [0.39, 3.51]

7 POPQ assessment Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

7.1 Ba POPQ

1

56

Mean Difference (IV, Fixed, 95% CI)

‐0.5 [‐0.98, ‐0.02]

7.2 Point C

1

56

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐1.28, 0.08]

7.3 Bp POPQ

1

56

Mean Difference (IV, Fixed, 95% CI)

0.10 [‐0.27, 0.47]

7.4 total vaginal length

1

56

Mean Difference (IV, Fixed, 95% CI)

0.60 [0.06, 1.14]

8 De novo urinary stress incontinence Show forest plot

1

56

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 De novo voiding disorders, urgency, detrusor overactivity or overactive bladder Show forest plot

2

93

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.29, 2.26]

10 De novo dyspareunia (1 year) Show forest plot

1

37

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.20, 3.67]

11 Sexual function (1 year) Show forest plot

1

35

Mean Difference (IV, Fixed, 95% CI)

1.0 [‐2.33, 4.33]

11.1 PISQ

1

35

Mean Difference (IV, Fixed, 95% CI)

1.0 [‐2.33, 4.33]

12 Quality of life (1 year) Show forest plot

2

84

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.05 [‐0.48, 0.38]

12.1 PQOL score

1

56

Std. Mean Difference (IV, Fixed, 95% CI)

0.10 [‐0.42, 0.63]

12.2 PFDI‐20

1

28

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.36 [‐1.11, 0.39]

13 Operating time (minutes) Show forest plot

4

232

Mean Difference (IV, Fixed, 95% CI)

10.34 [6.31, 14.36]

14 Blood transfusion Show forest plot

1

100

Risk Ratio (M‐H, Fixed, 95% CI)

2.13 [0.14, 32.90]

Figuras y tablas -
Comparison 3. Biological repair versus native tissue repair