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Mrežice ili transplatati koji se postavljaju kroz rodnicu u usporedbi s popravkom prirodnim tkivom u svrhu sprječavanja ispadanja organa male zdjelice kroz vaginalni otvor

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Appendices

Appendix 1. Types of operations

Sacral colpopexy

Aim
to correct upper genital tract prolapse

Indication
Usually reserved for recurrent prolapse of the upper vagina (recurrent cystocele, vault or enterocele) or massive vaginal eversion

Surgical technique

  • Usually performed under general anaesthesia

  • Performed through an incision on the lower abdomen or keyhole

  • The bladder and rectum are freed from the vagina and permanent mesh supports the front and back wall of the vagina

  • This mesh is secured to the sacrum (upper tailbone)

  • Peritoneum (lining of the abdominal cavity) is closed over the mesh

  • Other repairs are performed as required at the same time including paravaginal repair, perineoplasty, colposuspension or rectopexy

  • Bowel preparation is required prior to the surgery

McCall culdoplasty

Indications

  • Vault prolapse or an enterocele

  • Often performed at the time of vaginal hysterectomy to prevent future prolapse

Surgical technique

  • After the uterus is removed at the time of hysterectomy the uterosacral ligaments are identified and incorporated into the closure of the peritoneum and upper vagina using one to two sutures

  • An anterior or posterior vaginal repair is often performed at the same time

Sacrospinous fixation

Aim
This surgery offers support to the upper vagina, minimising risk of recurrent prolapse at this site. The advantage of this surgery is that vaginal length is maintained.

Indication
Upper vaginal prolapse (uterine or vault prolapse, enteroceles)

This procedure can be used in reconstructive vaginal surgery where increased vaginal length is required.

Procedure

  • The procedure can be performed under regional or general anaesthesia

  • A routine posterior vaginal incision is made and extended to the top of the vagina

  • Using sharp dissection, the vagina is freed from the underlying rectovaginal fascia and rectum until the pelvic floor (puborectalis) muscle is seen

  • Using sharp and blunt dissection, the sacrospinous ligament running from the ischial spine to the sacral bone is palpated and identified

  • Two sutures are placed through the strong ligament and secured to the top of the vagina. This results in increased support to the upper vagina. There is no shortening of the vagina

  • Other fascial defects in the vagina are repaired, and the vaginal skin is closed

Anterior vaginal repair (colporrhaphy)

Indication

  • Prolapse of the bladder or urethra

  • Sometimes used to treat urinary stress incontinence

Surgical technique

  • The procedure can be performed under regional or general anaesthesia

  • The vagina overlying the bladder and urethra is incised in the midline

  • Dissection in a plane directly below the vagina allows the damaged fascia supporting the bladder and urethra to be exposed

  • The fascia is plicated in the midline using delayed absorbable or permanent sutures

  • Sometimes excessive vaginal skin is removed

  • The vaginal skin is then closed

  • Other sites of prolapse are then repaired as required 

Posterior vaginal repair and perineoplasty

Indications
Treatment of rectocele (rectum bulges or herniates forward into the vagina) and defects of the perineum (area separating entrance of the vagina and anus)

Aim
correct defects in the rectovaginal fascia separating rectum and vagina while allowing bowel function to be maintained or corrected without interfering with sexual function

Surgical technique

  • An incision is made on the posterior wall of the vagina starting at the entrance and finishing at the top of the vagina

  • Dissecting the vagina and rectovaginal fascia from the vagina until the pelvic floor muscles (puborectalis) are located

  • Defects in the fascia are corrected by centrally plicating the fascia using delayed absorption sutures

  • The perineal defects are repaired by placing deep sutures into the perineal muscles to build up the perineal body

  • The overlying vaginal and vulval skin is then closed

  • A pack is usually placed into the vagina and a catheter into the bladder at the end of surgery

Anterior or posterior vaginal repair, or both (colporrhaphy)

Indications:

Anterior repair: treatment for prolapse of bladder (bladder bulges forward into the vagina; cystocele) or urethra.

Posterior repair: correction of bowel prolapse (rectum bulges forward into the vagina; rectocele).

Vault repair: treat prolapse of upper vagina.

Depending on the side of the defect, the repair can either be anterior, posterior, vault, or total. The repair is achieved by the placement of permanent mesh, which may result in a stronger repair.

Surgical technique

The procedure can be performed under regional or general anaesthesia.

Anterior vaginal repair

  • Midline incision to the vagina overlying the bladder and urethra

  • Dissection in a plane directly below the vagina and lateral of the bladder allows the damaged fascia supporting the bladder to be exposed

  • The fascia is plicated in the midline using sutures

  • Mesh can be used to reinforce the repair and can be used as an inlay or anchored through the obturator foramen and exiting through small incisions at both sides of the upper inner thigh

  • The vaginal skin is closed

Posterior and vault repair

  • An incision is made to the posterior wall of the vagina

  • Dissection below the vagina identifies the rectovaginal fascia and opens the space between the rectum and the pelvic floor muscle to the sacrospinous ligaments

  • Defects in the fascia are corrected by centrally plicating the fascia using sutures

  • Mesh can be used to reinforce the repair and can be used as an inlay or anchored bilaterally to the pelvic side wall and exiting through a small incision approximately 3 cm lateral and down from the anus

  • The vaginal skin is then closed

Vaginal paravaginal repair

Aim
The objective of this surgery is to reattach detached lateral vaginal fascia to its normal point of insertion on the lateral side wall. This firm area of attachment is termed the white line or arcus tendineus fascia pelvis.

Indication
The repair of anterior wall prolapse due to defects of the lateral supporting tissues

Procedure
The procedure can be performed under regional or general anaesthesia.

Routine anterior repair
The sharp dissection of the vagina from the bladder fascia continues laterally until the pelvic side wall can be identified.

Permanent or delayed absorbable sutures are placed from the lateral vagina to the firm pelvic side wall tissue (white line or arcus tendineus fascia pelvis). Three to four sutures are placed on each side.

A routine anterior repair with midline plication of the fascia, trimming of excess vaginal skin as required, and closure of the vaginal skin.

Appendix 2. Searches

Search strategy:

The Incontinence Group Specialised Register was searched using the Group's own keyword system (all searches were of the keyword field of Reference Manager 2012). The search terms used were:

({design.cct*} OR {design.rct*})
AND
({topic.prolapse*})
AND
({intvent.surg*})

Date of the most recent search of the register for this review: 6 July 2015.

Search registered trials: clinicaltrials.gov: date 1/6/2015 Terms: "Vaginal prolapse" "Surgery prolapse" with 175 trials identified

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