Reference

Study type

Characteristics

Intervention (I)

Controls (C)

Outcome measures and follow-up time

Results

Quality

assessment study

De Boer, 2009

Design

Prospective cohort study

N = 156

Country

Netherlands

Aim of the study:

to evaluate cervical amputation with uterosacral ligament

plication (modified Manchester) and compare it to vaginal

hysterectomy with high uterosacral ligament placation procedure with special regard to the middle compartment.

Inclusion criteria

women who

underwent either vaginal hysterectomy with high uterosacral ligament plication or cervical amputation with uterosacral plication in the years 2002–2007 in three large teaching hospitals in The Netherlands

Exclusion criteria:

Intervention

N =

Controls

N =

Primary outcomes:

Secundary outcomes:

Follow up:

Primary outcomes:

Yes

Selection bias

Yes, the choice for the type of surgery was made in mutual agreement between physician and patient.

Method of assessing the outcome

appropriately:

Patient characteristics and perioperative complications were collected from the medical files. All women underwent a full gynaecological examination including the pelvic organ prolapse quantification (POP-Q) score and were invited for a postoperative visit 1-year after the operation in which the POP-Q score was repeated.

The patient self-reported questionnaire is a composite of internationally well-known questionnaires that have been validated for the Dutch language. It contains diseasespecific

questions from the validated Dutch translation of

the incontinence impact questionnaire (IIQ) [10], urogenital distress inventory (UDI)

Selective loss to follow up:

No

Identification confounders and correction in analysis:

Yes, at postoperative visit 1 year later 51 women in Manchester and 48 women in vaginal hysterectomy group appeared.

Funding:

No conflicts of interest.

Dietz, 2010

Design

Nonblinded, multicenter RCT

N = 66

Country

Netherlands

Aim of the study:

To compare the

vaginal hysterectomy with the sacrospinous hysteropexy for the treatment of uterine descent stage2–4 in women with no medical history of pelvic surgery and with a normal uterus, cervix, and ovaries and compared differences in recovery time.

Inclusion criteria

- women with symptomatic pelvic organ prolapse, referred between February 1, 2004 and December 1,

2006

- presence of a uterine

descent stage2–4 according to the classification of the

International Continence Society and the patient’s desire

for surgical correction

- no medical history of pelvic surgery, normal uterus and ovaries on ultrasound examination, normal menstrual

bleeding pattern (if premenopausal), normal cervical cytology, and no insulin-dependent diabetes mellitus.

Exclusion criteria:

Intervention

sacrospinous

hysteropexy

N = 35

Controls

vaginal hysterectomy

N = 31

Primary outcomes:

recovery time

Secundary outcomes:

complications

anatomical outcomes, functional outcomes, and quality of life

Follow up:

1 year

Primary outcomes:

In the 66 women, there were six protocol deviations; two women underwent a vaginal hysterectomy instead of a sacrospinous hysteropexy (one woman because of inadequate visualization of the sacrospinous ligament, and in one woman, the reason for changing the procedure was not written down adequately in the clinical research file); and four women had an exclusion criterion that was overlooked before randomization. Two of them were diagnosed with insulin-dependent diabetes mellitus (one in each group) and two of them had a medical history of pelvic surgery (one in each group, cesarean delivery, and posterior colporrhaphy).

In both groups, no bladder or rectal injuries occurred; no blood transfusions or intensive care admissions were needed. Five days after surgery, one woman who underwent a vaginal hysterectomy was diagnosed with a distal occlusion of the right ureter.

At 1-year follow-up, 9 women (34, 27%) who had sacrospinous hysteropexy had recurrent uterine descent stage2 or more. Three women who underwent a sacrospinous hysteropexy had a stage4 prolapse before surgery. All these women were diagnosed with a recurrent uterine descent within 1 year. Two of these women

underwent repeat surgery. Repeat surgery for prolapse after a sacrospinous hysteropexy was performed in 11% (4/35) of patients (vaginal hysterectomy and/or colporrhaphy anterior). Surgery for prolapse after a vaginal hysterectomy occurred in 7% (2/31) of patients (colporrhaphy anterior and posterior; risk difference, 5%; 95% CI=−9 to 19).

Clearly defined groups:

Yes

Selection bias

No

Method of assessing the outcome

appropriately:

Information about complications during and after surgery and length of hospital stay were collected in the clinical research file of all study participants. At baseline and 1 year after surgery, women underwent pelvic examination using the pelvic organ quantification system (POP-Q). A prolapse

stage2–4 on gynecological examination 1 year after

surgery was considered a recurrence. Functional outcomes and quality of life were measured

with the urinary distress inventory (UDI) and the incontinence impact questionnaire (IIQ) before surgery and 1 year after surgery

Selective loss to follow up:

Four women in the vaginal hysterectomy group and four in the sacrospinous hysteropexy group did not returned the diary and/or questionnaires for a variety of reasons but mostly because this was too much of a bother. All these women, except for one, were contacted at 1-year follow-up. Two women of the sacrospinous hysteropexy group did not return for a gynecological examination at 1-year followup. One woman was lost to follow-up 6 weeks after surgery for unknown reasons. The other woman was only examined at 6-month follow-up.

Identification confounders and correction in analysis:

Age, however adjusting for age did not alter findings.

Funding:

Not reported

Jeng, 2005

Design

RCT

N = 158

Country

Taiwan

Aim of the study:

To examine changes in sexuality after total vaginal hysterectomy (TVH) or transvaginal sacro-spinous uterine suspension (SSUS) for uterine prolapse

Inclusion criteria

- women <50 years old and sexually active within the last 6 months before surgical intervention

- grade 2 or 3 uterine prolapse

Exclusion criteria:

- major medical disorders

Intervention

TVH

N = 78

Controls

SSUS

N = 80

Primary outcomes:

Sexual function

Secundary outcomes:

Follow up:

Primary outcomes:

Clearly defined groups:

Yes

Selection bias

Not expected, however randomisation procedure was not described

Method of assessing the outcome

appropriately:

Sexual functioning before and 6 months after surgery was examined via a face-to-face questionnaire (Rosen’s Female Sexual Function Index). Sexual interest, sexual satisfaction, frequency of sexual intercourse and frequency of orgasm were measured using an analogue scale.

Selective loss to follow up:

No

Identification confounders and correction in analysis:

No

Funding:

Not reported

Maher, 2001

Design

Retrospective cohort study

N = 70

Country

Australia

Aim of the study:

to determine the

efficacy of these procedures and to determine the role of

vaginal hysterectomy at prolapse surgery for uterovaginal

prolapse.

Inclusion criteria

- women who underwent between June 1992 and June 1998 sacrospinous hysteropexy and  vaginal hysterectomy and sacrospinous fixation of the vault in the

management of symptomatic uterovaginal prolapse to or beyond the introitus with straining.

- Uterine preservation was considered in women with normal cervical cytology and no abnormal uterine

bleeding.

Exclusion criteria:

Intervention

sacrospinous hysteropexy

N = 34

Controls

vaginal hysterectomy and sacrospinous

fixation

N = 36

Primary outcomes:

Subjective and objective failure

Secundary outcomes:

Follow up:

33 months in the hysterectomy group

and 26 months in the hysteropexy group.

Primary outcomes:

The subjective success rate (no awareness of prolapse) was 86% in the hysterectomy

group and 78% in the hysteropexy group (P = 0.70). The objective success rate (no prolapse beyond the midvaginal point) was 72% and 74%, rspectively (P = 1.00). The patient-determined satisfaction rate was 86% in the hysterectomy group and 85% in the hysteropexy group (P = 1.00).

Postoperatively, no patient required blood transfusion and there were no thromboembolic events. Three women reported significant buttock pain postoperatively, 1 in the hysterectomy group and 2 after the hysteropexy.

Five women underwent further gynecological surgery. In the hysterectomy group

there was one vaginal repair and one abdominal sacral colpopexy for prolapse. In the hysteropexy group 2 women required a vaginal hysterectomy and repair for

uterine prolapse, one 2 years postpartum. One woman had an abdominal hysterectomy for menorrhagia.

Postoperativley, 59% in the hysterectomy group and 63% in the hysteropexy group were sexually active (P = 0.79) with 3% and 7% respectively reporting dysparenia.

Clearly defined groups:

Yes

Selection bias

Possible, self-slected to hysterectomy

or hysteropexy.

Method of assessing the outcome

appropriately:

Prolapse was graded using a modified Baden–Walker classification. Between November 1998 and March 1999 the 56 women underwent independent evaluation by a non-surgical

author who was unaware of the surgery performed. Evaluation included a standardized questionnaire and site-specific vaginal examination, and patient satisfaction was recorded using a visual analog scale (0–100). Women with no symptoms of genital prolapse were classified as a subjective success. Objective successes were those women who on examination had no vaginal prolapse beyond the halfway point of the vagina.

Selective loss to follow up:

Of the 14 women lost to follow-up, 7 had since died, 3 suffered senile dementia and 4 were unable to be contacted.

Identification confounders and correction in analysis:

No

Funding:

Not reported

Roovers, 2004

Design

Multicenter RCT

N = 82

Country

Netherlands

Aim of the study:

To compare the effects of vaginal hysterectomy (combined with anterior and/or posterior

colporraphy) and abdominal sacro-colpopexy (with preservation of the uterus) on urogenital function.

Inclusion criteria

- patients enrolled

between January 1998 and July 2000

- patients with

intact uteri

- uterine prolapse stages II–IV

Exclusion criteria:

- presence of an adnexal mass, a history of more than two

abdominal pelvic surgical procedures, extreme obesity

(body mass index >35 kg/m2), prior inflammatory bowel or pelvic disease and faecal incontinence because of an internal or external anal sphincter defect

Intervention

abdominal sacro-colpopexy (with preservation of the uterus)

N = 41

Controls

vaginal hysterectomy combined with anterior and/or posterior colporraphy if

indicated

N = 41

Primary outcomes:

UDI

Secundary outcomes:

Follow up:

1 year

Primary outcomes:

Two women in abdominal surgery preferred vaginal surgery after randomisation.

For all domains of the UDI, the reduction in score was higher in the vaginal group than in the abdominal group. At one year after surgery, the vaginal group scored

significantly lower on the discomfort/pain domain, overactive bladder domain and the obstructive micturition domain, as compared with the abdominal group.

Findings at pelvic examination were similar before surgery and at six weeks, six months and one year after surgery. Before surgery, a stage II or more cystocele was

present in 85% of the vaginal group and 88% of the abdominal group and a stage II or more rectocele was present in 37% of the vaginal group and 32% of the

abdominal group. At one year after surgery, only 5% of patients in both groups had a stage II or more vault prolapse (vaginal group) or uterine prolapse (abdominal group). A stage II or more cystocele was present in 39% of the vaginal group and 36% of the abdominal group and a stage II or more rectocele was present in 15% of the vaginal group and 5% of the abdominal group.

Clearly defined groups:

Yes

Selection bias

No

Method of assessing the outcome

appropriately:

A standardised urogynaecologic interview and a classification of the genital prolapse according to the recommendations of the ICS.

Participating patients completed the urogenital distress inventory (UDI), before and at six weeks, six months and one year after surgery, to measure discomfort of prolapse and micturition symptoms.

For each patient, the following information was collected: duration of surgery, amount of blood loss, complications during surgery, complications during hospital stay, duration of hospital stay and late complications due to surgery. During the first year after surgery, the number of visits to a gynaecologist or general practitioner because of prolapse symptoms, micturition symptoms, defecation symptoms and other symptoms related to the performed prolapse surgery were documented for each patient. We also scored how

often repeated prolapse surgery was performed or planned because of recurrence of genital prolapse. Recurrence of prolapse was defined as a combination of a stage II or more genital prolapse in combination with symptoms of pelvic floor dysfunction.

The data were analysed by intention-to-treat.

Selective loss to follow up:

In abdominal surgery group there were 3 women lost to follow up, this was 1 in vaginal surgery group. All had no motivation to complete questionnaire/visit the hospital to undergo pelvic examination

Identification confounders and correction in analysis:

As UDI scores were at baseline somewhat

higher in the abdominal group than in the vaginal group, we adjusted in the repeated measurement analysis for differences in UDI scores before surgery.

Funding:

Not reported

Roovers, 2005

Design

Multicenter RCT

N = 82

Country

Netherlands

Aim of the study:

to compare post-operative pain, quality of life, and physical performance between

patients undergoing vaginal and abdominal surgical correction

of uterovaginal prolapse.

Inclusion criteria

- patients enrolled

between January 1998 and July 2000

- patients with

intact uteri

- uterine prolapse stages II–IV

Exclusion criteria:

- presence of an adnexal mass, a history of more than two

abdominal pelvic surgical procedures, extreme obesity

(body mass index >35 kg/m2), prior inflammatory bowel or pelvic disease and faecal incontinence because of an internal or external anal sphincter defect

Intervention

abdominal sacro-colpopexy (with preservation of the uterus)

N = 41

Controls

vaginal hysterectomy combined with anterior and/or posterior colporraphy if

indicated

N = 41

Primary outcomes:

Secundary outcomes:

Follow up:

Primary outcomes:

Two women in abdominal surgery preferred vaginal surgery after randomisation.

Data were complete in 68 (82.9%) patients of whom 35 had undergone vaginal surgery and 33 had undergone abdominal surgery.

Patients who were operated by vaginal approach did not resume daily activities sooner than patients who were operated by abdominal approach (logrank test P = 0.57).

Clearly defined groups:

Selection bias

Method of assessing the outcome

appropriately:

All patients had undergone a standardized urogynecologic interview before surgery as well as a complete physical examination including a classi¢cation of the genital prolapse

according to the recommendations of the ICS. We also performed urodynamic investigation. All patients were asked to answer the RAND-36 before surgery and 6 weeks after surgery. Two months after start of inclusion, we began to ask participating patients to also keep a diary, starting from the day before surgery until 6 weeks after surgery.

During admission, the nursing sta¡ daily scored

whether or not and in what dosages analgesics were administered. Post-operative pain management was similar in both groups

An intention to treat analysis was performed.

Selective loss to follow up:

In abdominal surgery group there were 3 women lost to follow up, this was 1 in vaginal surgery group. All had no motivation to complete questionnaire/visit the hospital to undergo pelvic examination

Identification confounders and correction in analysis:

Funding:

Thys, 2011

Design

Multicenter retrospective case-control study

N = 196

Country

Netherlands

Aim of the study:

to compare the Manchester Fothergill (MF) procedure

with vaginal hysterectomy (VH) as surgical treatment of

uterine descent.

Inclusion criteria

- patients who

underwent either a MF or VH for primary apical compartment

prolapse between January 2000 and December 2005.

Exclusion criteria:

- Women who underwent combined prolapse and incontinence surgery

Intervention

Manchester Fothergill

N = 98

Controls

vaginal hysterectomy

N = 98

Primary outcomes:

UDI

Secundary outcomes:

Morbidity,

recurrence of

POP,  reintervention

DSQOL and sexual function

Follow up:

6 (1.5–9.5)years

Primary outcomes:

The average time to undergo a re-operation for recurrent prolapse was 9 months shorter in the MF group as compared to the VH group (log rank: p=0.03); Nevertheless, we did not find a significant difference in recurrence rates between the

VH and MF procedure (hazard ratio for recurrence of POP between both groups is 2.5 in favour of the MF group (HRR 2.5, 95% CI 0.8–8.0)).

Clearly defined groups:

Yes, the identified MF patients were matched to VH patients for pre-operative grade of prolapse (Baden and Walker classification, age and parity.

Selection bias

Possible, the treatment selection was based on the preference of the gynaecologist in consultation

with the patient.

Method of assessing the outcome

appropriately:

We collected data from patient records at the time of operation, medical history, previous conservative treatment (pessary, physical therapy) and stage of prolapse from hospital record files. Data on recurrence rates were collected from patient record files and from the follow-up

questionnaire. Data on duration of surgery and admission, blood loss and complications related to surgery were registered from patient record files.

3 to 8 years after the intervention, all patients were approached and asked to complete the Dutch validated version of the UDI, the Defecatory Distress Inventory (DDI) and the Incontinence

Impact Questionnaire (IIQ).

Six weeks after surgery, patients underwent a standardized follow-up visit including assessment of pelvic floor symptoms and of the prolapse using the Baden andWalker classification. Follow-up data were collected from patient’s files and

validated questionnaires

Selective loss to follow up:

Fortyone patients were lost to follow-up, nine patients because they had died, two patients because they suffered from dementia, whereas 29 patients could not be contacted.

Identification confounders and correction in analysis:

No

Funding:

No conflict of interest

Van Brummen,

2003

Design

Multicenter cohort study

N = 103

Country

Netherlands

Aim of the study:

To assess the

occurrence of micturition symptoms after sacrospinous

hysteropexy compared to vaginal hysterectomy.

Inclusion criteria

- women who underwent between January 1997 and June 2001 surgery for the management of a symptomatic genital prolapse

- descensus uteri reaching to or

beyond the hymen (grade 2 or more).

Exclusion criteria:

- sacrospinous

ligament fixation for vaginal vault prolapse

- combined

Surgery

- repeated surgery because of a

recurrence of their genital prolapse in the follow-up period.                 

Intervention

sacrospinous hysteropexy

N = 54

Controls

vaginal hysterectomy

with a vaginal vault suspension

N = 49

Primary outcomes:

Secundary outcomes:

Follow up:

Primary outcomes:

No differences in anatomical outcome were observed between the two groups. Recurrence of a grade 2 or higher vaginal prolapse (cystocele, rectocele, enterocele and descensus uteri) occurred in 2 of the 30 (6.7%) women after vaginal

hysterectomy and in 5 of the 44 (11.4%) after sacrospinous hysteropexy. This difference is not statistically significant.

Clearly defined groups:

Yes

Selection bias

Possible, retrospective cohort, not clear which patients received which intervention

Method of assessing the outcome

appropriately:

Data were obtained from the patients’ medical records. The grade of genital prolapse was classified following the halfway system of Baden and Walker. Urogenital symptoms were measured with the Dutch version of the Urogenital Distress Inventory (UDI). In the questionnaire we included questions to assess educational level, the use of incontinence pads, the satisfaction with the

outcome of surgery and the timespan between surgery and complete recovery.

Selective loss to follow up:

In July 2001 these 103 women were sent a postal questionnaire and data were obtained from their

medical files; 74 women (72%) responded and returned a completed questionnaire; 44 women in the sacrospinous hysteropexy group and 30 in the vaginal hysterectomy group.

Identification confounders and correction in analysis:

No

Funding:

Not reported

Reference

Study type

Characteristics

Intervention (I) Controls (C)

Outcome measures and follow-up time

Results

Quality

assessment study

Maher, 2013

Design

Systematic review

N = 56 RCTs, 5954 women.

Country

12 countries (Italy, USA, Australia, UK,

Netherlands, Taiwan, Finland, Belgium, Chile, Czech Republic,

Egypt, France, Singapore and Sweden)

Aim of the study:

To determine the impact of pelvic organ prolapse surgery including

patient symptoms, examination findings, complications, cost, and

bladder, bowel and sexual function.

Inclusion criteria

Randomised controlled trials (RCT) or quasi-randomised controlled clinical trials (CCT) in which at least one arm was a surgical intervention for pelvic organ prolapse. Trials including any type of abdominal or vaginal surgery for pelvic organ prolapse in at least one trial group. Comparison interventions included no treatment, conservative management, mechanical device, or an alternative approach to surgery.

Adult women seeking treatment for symptomatic pelvic organ prolapse. Both primary and recurrent prolapse were considered.

Pelvic organ prolapse includes:

• upper vaginal prolapse (uterine or vaginal vault);

• anterior vaginal wall prolapse (cystocele, urethrocele,

paravaginal defect);

• posterior vaginal wall prolapse (enterocele, rectocele,

perineal deficiency).

Exclusion criteria:

Studies were excluded if they were not randomised or quasi-randomised trials of surgery for women with pelvic organ prolapse.

Given the diverse nature of pelvic organ prolapse, to allow a meaningful analysis of the data the review was divided into sections

related to the site of the prolapse.

1. Upper vagina including cervix, uterus and vault.

2. Anterior vaginal wall.

3. Posterior vaginal wall.

The following comparisons were made:

1. One type of upper vaginal prolapse (uterine and vaginal

vault) repair versus another

Including open or laparoscopic abdominal sacral colpopexy, vaginal sacrospinous colpopexy, vaginal or abdominal hysterectomy, high levator myorrhaphy, uterosacral ligament vault suspension,

vaginal Mayo McCall repair

2. One type of anterior vaginal wall prolapse repair versus another

Including anterior vaginal wall repair (anterior colporrhaphy)with or without graft reinforcement, abdominal paravaginal repair

3. One type of posterior vaginal wall prolapse repair versus another

Including posterior vaginal wall repair (posterior colporrhaphy)

with or without graft reinforcement, transanal repair, abdominal posterior repair.

4. Any type of surgical prolapse repair versus conservative

treatment

5. Any type of surgical prolapse repair versus mechanical devices

6. No graft versus use of graft (synthetic mesh or biological

graft)

7. One type of graft (synthetic mesh or biological graft)

versus another type of graft

8. One type of suture versus another type of suture

9. Prolapse surgery and bladder function

- Women’s observations related to prolapsed

- Clinicians’ observations related to prolapse

- Quality of life

- Measures of associated symptoms (objective or subjective)

- Surgical outcome measures

- Complica-tions

- Economic measures

Follow-up:

Seven trials (Ali 2006 abstract; Borstad 2010; Farid 2010; Jeng

2005; Pantazis 2011; Schierlitz 2007; Vijaya 2011 abstract) reported

median follow up of less than one year and only four trials

reported outcomes at greater than five years (Colombo 1997;

Colombo 2000; Roovers 2004; Culligan 2005).

Primary outcomes:

Risk of bias in included studies

Allocation

Including the 26 new or updated trials, sufficient detail was provided in 31 of 56 RCTs, which adequately described the randomization r process and confirmed that secure concealment of the randomisation process was used, for example allocation by a remote person or sealed envelopes (Ali 2006 abstract; Allahdin 2008; Al-Nazer 2007; Altman 2011; Benson 1996; Borstad 2010; Brubaker 2008; Bump 1996; Costantini 2008; Culligan 2005; Dietz 2010; Feldner 2010; Gandhi 2005; Guerette 2009; Hviid 2010; Iglesia 2010; Maher 2004; Maher 2011; Meschia 2004;

Meschia 2004a; Meschia 2007; Minassian 2010 abstract; Natale2009; Nguyen 2008; Nieminen 2008; Paraiso 2006; Roovers 2004; Sivaslioglu 2008; Sung 2012; Weber 2001). However, in one of these trials four women received the opposite treatment

to their randomised allocation (mesh instead of fascia) and were subsequently analysed in the mesh group thus compromising the randomisation process; an intention-to-treat analysis was not used (Culligan 2005). Of the remainder, 23 trials stated that they used computer generated number lists but it was unclear whether the allocation was concealed before assignment (Braun 2007 abstract; Carey 2009;

Colombo 1996; Colombo 1997; De Ridder 2004 abstract; de Tayrac 2008; Costantini 2007; Halaska 2012; Menefee 2011; Kahn 1999; Lo 1998; Natale 2010; Nieminen 2004; Pantazis 2011; Paraiso 2011; Rondini 2011 abstract; Sand 2001; Schierlitz

2007; Thijs 2010 abstract; Vijaya 2011 abstract; Vollebregt 2011; Withagen 2011; Wei 2011); another gave no details of the randomization process (Jeng 2005). The last trial stated that a computer generated but open number list was used and it was, therefore classified as a quasi-randomised trial (Colombo 2000).

Blinding

Women and surgeons could not be blinded to the procedure when different surgical routes were compared (Benson 1996; Braun 2007 abstract;Colombo 2000;Maher 2004;Maher 2011;Roovers 2004). Blinding of patients and the post-operative reviewer were performed in nine trials (Allahdin 2008; Brubaker 2008; Culligan

2005; Iglesia 2010; Menefee 2011; Nguyen 2008; Paraiso 2006; Paraiso 2011;Sung 2012). Outcome assessments were conducted by non-surgeons in 16 trials (Allahdin 2008; Al-Nazer 2007; Benson 1996; Costantini 2008; Culligan 2005; Feldner 2010;

Iglesia 2010; Maher 2004; Maher 2011; Meschia 2007; Natale 2009; Paraiso 2006; Paraiso 2011; Roovers 2004; Sung 2012; Weber 2001).

Incomplete outcome data

Loss to follow up was a variable problem, ranging from zero ( Allahdin 2008; Colombo 1997; Jeng 2005; Kahn 1999; Meschia 2004; Meschia 2004a) to 53% (49 out of 93) in Guerette 2009. Weber also reported a statistically significant higher loss to follow up in one armof the trial (ultra-lateral anterior vaginal wall repair) (Weber 2001).

Clearly defined groups:

A description of the baseline characteristics of the groups showed that they were comparable in all except four trials. In one trial, 7% of women

only had Stage 1 prolapse before operation, which would generally be regarded as a success if recorded post-operatively.

Selection bias

See results

Method of assessing the outcome

appropriately:

Generally the impact of surgery on associated pelvic floor symptoms including bladder, bowel and sexual function, quality of life, cost and patient satisfaction is improving. Validated pelvic floor questionnaires were reported in 13 trials (Altman 2011; Brubaker 2008; Costantini 2008; de Tayrac 2008; Iglesia 2010; Maher 2004;Maher 2011;Menefee 2011; Nguyen 2008; Roovers 2004;

Sivaslioglu 2008; Thijs 2010 abstract;Withagen 2011), cost issues by three trialists (Benson 1996; Maher 2004; Paraiso 2011) and impact of surgery on quality of life and patient satisfaction in five

trials (Brubaker 2008; Iglesia 2010; Maher 2004; Maher 2011; Withagen 2011).

Assesor of the effect adequately blinded:

Only 28 out of 56 trials provided evidence of secure methods of allocation to randomised groups, and one trial which used an open number list was classed as quasi-randomised. In one trial

four women were incorrectly analysed in the group opposite to their allocation, as they received the alternative treatment.

Selective loss to follow up:

Loss to follow up (dropouts) ranged from 0% to 52%,.

Identification confounders and correction in analysis:

No

Funding:

Unfortunately in several studies in this review this conflict was feasible and exacerbated by not ensuring reviewers were blinded, resulting in a possible heightened risk of bias in the outcomes reported (Altman 2011; Carey 2009; Withagen 2011).

Comparison 6.

No graft versus use of graft (synthetic mesh or biological graft) in any prolapse surgery

N = 21 RCTs, 5954 women.

Twenty-one trials compared standard (no graft or mesh) vaginal prolapse repairs with those which included mesh or graft material:

• polyglactin mesh (absorbable synthetic, Vicryl) (Allahdin

2008; Sand 2001; Weber 2001);

• porcine dermis graft (biological, Pelvicol) (Hviid 2010 (anterior compartment); Meschia 2007);

• non-absorbable synthetic mono-filament permanent

polypropylene mesh (Ali 2006 abstract; Al-Nazer 2007; Altman

2011; Carey 2009; Halaska 2012; Iglesia 2010; Nguyen 2008;

Nieminen 2008; Sivaslioglu 2008;Thijs 2010 abstract;

Vollebregt 2011; Withagen 2011).

Comparison 7

One type of graft (synthetic mesh or biological graft) versus another type of graft

Comparison 1

Surgery for upper vaginal (vault or uterine) prolapse

Abdominal sacral colpopexy versus vaginal sacrospinous

colpopexy

Three trials were considered to be similar enough to address

the comparison of abdominal sacral colpopexy and vaginal

sacrospinous colpopexy (Benson 1996; Lo 1998; Maher 2004).

Sacral colpopexy and abdominal hysterectomy versus vaginal

Mayo McCall culdoplasty and vaginal hysterectomy

One small trial (Braun 2007 abstract) compared 47 women

who underwent total abdominal hysterectomy (TAH) and sacral

colpopexy using synthetic combined absorbable and non-absorbable (Vypro) mesh with 47 women who underwent vaginal hysterectomy (VH) plus anterior and posterior colporrhaphy plus the Mayo McCall procedure using delayed absorbable polydioxanone (PDS) sutures.

Abdominal sacral colpopexy versus high vaginal uterosacral colpopexy (HUSLS)

In a single study,Rondini 2011 abstract compared sacral colpopexy (n = 54) and high uterosacral vault suspension (n = 56) in women with point C greater than 1 cm beyond the introitus.

Abdominal uterine preservation versus vaginal hysterectomy and repair

One trial (Roovers 2004) compared abdominal sacral hysteropexy with uterine preservation versus vaginal hysterectomy and repair

with vault fixation to the uterosacral-cardinal ligament complex.

Vaginal sacrospinous uterine suspension versus vaginal

hysterectomy

In another trial (Jeng 2005), vaginal sacrospinous uterine hysteropexy (suspension) with uterine preservation was compared with vaginal hysterectomy.

Open abdominal sacral colpopexy versus laparoscopic sacral

colpopexy (LSC)

A single multi-centre equivalence trial (Pantazis 2011) compared open and LSC in the treatment of POP-Q Stage 2 vault prolapse.

Laparoscopic sacral colpopexy (LSC) versus total vaginal

polypropylene mesh kit (TVM)

A single centre randomised controlled trial compared LSC (n = 53) and a total vaginal polypropylenemesh kit (Prolift) (n = 55) in women with grade 2 post-hysterectomy vaginal vault prolapse at mean two year review (Maher 2011).

Total vaginal polypropylene mesh (TVM) versus

sacrospinous colpopexy

A single multi-centre randomised trial compared sacrospinous colpopexy (n = 83) and native tissue repairs with the total vaginal

mesh Prolift (n = 85) for grade 2 or greater post-hysterectomy prolapsed (Halaska 2012).

Comparison 2

One method of anterior prolapse repair versus another surgical method

• 10 trials assessed anterior colporrhaphy versus

polypropylene mesh (Ali 2006 abstract; Al-Nazer 2007; Altman

2011; Carey 2009; Nguyen 2008; Nieminen 2008; Menefee

2011; Sivaslioglu 2008; Thijs 2010 abstract; Vollebregt 2011).

• two were comparable in terms of type of population (women with prolapse only) and types of operation (anterior repair with and without absorbable mesh) (Sand 2001; Weber 2001);

• Six assessed anterior colporrhaphy alone versus armed transobturator polypropylene meshes (Altman 2011; Nguyen 2008; Nieminen 2008); Sivaslioglu 2008; Thijs 2010 abstract; Vollebregt 2011).

• Two assessed anterior colporrhaphy alone versus

polypropylene mesh alone (Menefee 2011; Sivaslioglu 2008).

• Four trials assessed anterior colporrhaphy alone versus

anterior colporrhaphy plus polypropylene mesh (Ali 2006

abstract; Nguyen 2008; Nieminen 2008; Carey 2009).

• Two trials compared anterior colporrhaphy and self-styled

armed transobturator polypropylene mesh (Nieminen 2008; Sivaslioglu 2008).

• Four trials compared anterior colporrhaphy and

commercial transobturator polypropylene mesh kits (Altman 2011; Nguyen 2008; Thijs 2010 abstract; Vollebregt 2011).

Comparison 3

One method of posterior prolapse repair versus another surgical method

Three small trials compared vaginal and transanal approaches to the management of rectocele (Farid 2010; Kahn 1999; Nieminen 2004) and two others examined posterior repair with and without mesh reinforcement (Paraiso 2006; Sand 2001).One of these trials

compared three techniques to correct posterior vaginal compartment prolapse (Paraiso 2006).