Genital prolapse in women

Abstract

Introduction

Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur. Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-surgical treatments in women with genital prolapse? What are the effects of surgical treatments in women with anterior vaginal wall prolapse? What are the effects of surgical treatments in women with posterior vaginal wall prolapse? What are the effects of surgical treatments in women with upper vaginal wall prolapse? What are the effects of using different surgical materials in women with genital prolapse? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 15 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review, we present information relating to the effectiveness and safety of the following interventions: abdominal Burch colposuspension; abdominal sacral colpopexy; abdominal sacrohysteropexy; anterior colporrhaphy with mesh reinforcement; laparoscopic surgery; mesh or synthetic grafts; native (autologous) tissue; open abdominal surgery; pelvic floor muscle exercises; posterior colporrhaphy (with or without mesh reinforcement); posterior intravaginal slingplasty (infracoccygeal sacropexy); sacrospinous colpopexy (vaginal sacral colpopexy); sutures; traditional anterior colporrhaphy; transanal repair; ultralateral anterior colporrhaphy alone or with cadaveric fascia patch; vaginal hysterectomy; vaginal oestrogen; vaginal pessaries; and vaginal sacrospinous colpopexy.

Key Points

Prolapse of the uterus or vagina is usually the result of loss of pelvic support, and causes mainly non-specific symptoms. It may affect over half of women aged 50 to 59 years, but spontaneous regression may occur.

• Risks of genital prolapse increase with advancing parity and age, increasing weight of the largest baby delivered, and hysterectomy.

We don't know whether pelvic floor muscle exercises or vaginal oestrogen improve symptoms in women with genital prolapse, as we found few studies of adequate quality.

• The consensus is that vaginal pessaries are effective for relief of symptoms in women waiting for surgery, or in whom surgery is contraindicated, but we don't know this for sure.

In women with anterior vaginal wall prolapse, anterior vaginal wall repair may be more effective than Burch colposuspension at reducing recurrence, and adding mesh reinforcement to anterior colporrhaphy can reduce recurrence.

• Burch colposuspension may be more effective than anterior vaginal wall repair at reducing stress incontinence.

In women with posterior vaginal wall prolapse, posterior colporrhaphy is more likely to prevent recurrence compared with transanal repair of rectocoele or enterocoele.

• We don't know whether adding mesh reinforcement improves success rates in women having posterior colporrhaphy.

In women with upper vaginal wall prolapse, abdominal sacral colpopexy reduces the risk of recurrent prolapse, and of postoperative dyspareunia and stress incontinence compared with sacrospinous colpopexy.

• Posterior intravaginal slingplasty may be as effective as vaginal sacrospinous colpopexy at preventing recurrent prolapse.

• Vaginal hysterectomy and repair may reduce the need for re-operation and may be more effective at reducing symptoms, compared with abdominal sacrohysteropexy.

We don't know how surgical treatment compares with non-surgical treatment in women with prolapse of the upper, anterior, or posterior vaginal wall.

About this condition

Definition

Genital prolapse (also known as pelvic organ prolapse) refers to uterine, uterovaginal, or vaginal prolapse. Genital prolapse has several causes but occurs primarily from loss of support in the pelvic region. For ease of understanding, in this review we have attempted to use the most common and descriptive terminology. In uterine prolapse the uterus descends into the vaginal canal with the cervix at its leading edge; this may, in turn, pull down the vagina, in which case it may be referred to as uterovaginal prolapse. In the case of vaginal prolapse, one or more regions of the vaginal wall protrude into the vaginal canal. Vaginal prolapse is classified according to the region of the vaginal wall that is affected: a cystocoele involves the upper anterior vaginal wall; urethrocoele the lower anterior vaginal wall; rectocoele the lower posterior vaginal wall; and enterocoele the upper posterior vaginal wall. After hysterectomy, the apex of the vagina may prolapse as a vault prolapse. This usually pulls down the anterior and posterior vaginal walls as well. The two main systems for grading the severity of genital prolapse, the Baden–Walker halfway system[1] and the Pelvic Organ Prolapse Quantification (POPQ) system,[2] are summarised in table 1 . Mild genital prolapse may be asymptomatic. Symptoms of genital prolapse are mainly non-specific. Common symptoms include pelvic heaviness, genital bulge, and difficulties during sexual intercourse, such as loss of vaginal sensation. Symptoms that may be more commonly associated with specific forms of prolapse include: urinary incontinence, which is associated with cystocoele; incomplete urinary emptying, which is associated with cystocoele or uterine prolapse, or both; and the need to apply digital pressure to the perineum or posterior vaginal wall for defecation, which is associated with rectocoele.[3]

Table 1.

Standard grading systems for the severity of genital prolapse

Baden–Walker halfway system[1]		POPQ system*[2]
Grade	Position of prolapse site†	Stage	Position of prolapse site†
0	No prolapse	0	No prolapse
1	Halfway to hymen	1	>1 cm above the hymen
2	To hymen	2	1 cm or less proximal or distal to the plane of the hymen
3	Halfway past hymen	3	>1 cm below the plane of the hymen, but protrudes no further than 2 cm less than the total vaginal length
4	Maximum descent	4	Eversion of the lower genital tract is complete

*The Pelvic Organ Prolapse Quantification (POPQ) system is an adaptation of the Baden–Walker halfway system.[2] Since 1996, the POPQ has been internationally recognised as a standard classification system for genital prolapse. The POPQ is more accurate than the Baden–Walker system because it measures, in centimetres, the positions of 9 sites of the vagina and the perineal body in relation to the hymen, to create a tandem vaginal profile before assigning site specific ordinal stages. The main limitation of the POPQ system is that it is more complex to learn and communicate verbally than the original Baden–Walker system. †Both systems measure the position of the most distal portion of the prolapse site during the Valsalva manoeuvre.

Incidence/ Prevalence

Prevalence estimates vary widely, depending on the population and the way in which women were recruited into studies. One study conducted in the US (497 women aged 18–82 years attending a routine general gynaecology clinic) found that 93.6% had some degree of genital prolapse (43.3% POPQ stage 1, 47.7% POPQ stage 2, 2.6% POPQ stage 3, and 0% POPQ stage 4).[4] The incidence of clinically relevant prolapse (POPQ stage 2 or higher) was found to increase with advancing parity: non-parous, 14.6%; one to three births, 48.0%; and more than three births, 71.2%. One Swedish study (487 women) found that 30.8% of women between the ages of 20 and 59 years had some degree of genital prolapse on clinical assessment.[5] The prevalence of genital prolapse increased with age, from 6.6% in women aged 20 to 29 years to 55.6% in women aged 50 to 59 years. A cross-sectional study (241 perimenopausal women aged 45–55 years seeking to enter a trial of HRT) found that 23% had POPQ stage 1 genital prolapse, 4% had POPQ stage 2 prolapse, and no women had POPQ stage 3 or 4 prolapse.[6] One cross-sectional study conducted in the UK (285 perimenopausal and postmenopausal women attending a menopause clinic with climacteric symptoms) found that 20% had some degree of uterovaginal or vault prolapse, 51% some degree of anterior wall vaginal prolapse, and 27% some degree of posterior wall vaginal prolapse.[7] Severe prolapse (equivalent to POPQ stage 3 or 4) was found in 6% of women. One prospective study (412 postmenopausal women aged 50–79 years) found that the baseline prevalence of cystocoele was 24.6% (prevalence was 14% for grade 1 [in vagina], 10% for grade 2 [to introitus], and 1% for grade 3 [outside vagina]), the baseline prevalence of rectocoele was 12.9% (prevalence was 7.8% for grade 1 and 5.1% for grade 2), and the baseline prevalence of uterine prolapse was 3.8% (prevalence was 3.3% for grade 1 and 0.6% for grade 2).[8] Among women who entered the study, the annual incidence of cystocoele was 9%, rectocoele was 6%, and uterine prolapse was 2%.

Aetiology/ Risk factors

The strongest risk factor for pelvic organ prolapse is parity,[9] because childbirth can cause damage to the pudendal nerves,[10] fascia, and supporting structures, as well as muscle.[11] A Swedish population-based study found that the prevalence of genital prolapse was higher in parous women (44%) than in non-parous women (5.8%). In addition, it found an association with pelvic floor muscle tone and genital prolapse.[5] One case-control study found that other strong risk factors for severe (POPQ stages 3 or 4) genital prolapse are increasing age (OR 1.12 for each additional year, 95% CI 1.09 to 1.15), increasing weight of largest baby delivered vaginally (OR 1.24 for each additional 1 lb [450 g], 95% CI 1.06 to 1.44), previous hysterectomy (OR 2.37, 95% CI 1.16 to 4.86), and previous surgery for genital prolapse (OR 5.09, 95% CI 1.49 to 17.26).[12] The study found no significant association between severe genital prolapse and chronic medical conditions such as obesity, hypertension, or COPD.

Prognosis

We found no reliable information about the natural history of untreated mild genital prolapse (POPQ stages 1 and 2, Baden–Walker grades 1 and 2). We found one prospective study on the progression of genital prolapse in women who were treated or untreated with HRT (oestrogen plus progesterone).[8] However, the results were not reported separately by treatment group and therefore they may not apply to untreated women. In addition, the investigators used an examination technique of which the reliability, reproducibility, and ability to discriminate between absence of prolapse and mild prolapse was not known. It found that, over 1 year, cystocoeles progressed from grade 1 to grades 2 or 3 in 9% of cases, regressed from grades 2 or 3 to grade 0 in 9%, and regressed from grade 1 to grade 0 in 23%. Rectocoeles progressed from grade 1 to grades 2 or 3 in 1%, but regressed from grades 2 or 3 to grade 0 in 3%, and from grade 1 to grade 0 in 2%. Uterine prolapse regressed from grade 1 to grade 0 in 48%. The incidence of morbidity associated with genital prolapse is also difficult to estimate. The annual incidence of hospital admission for prolapse in the UK has been estimated at 2.04 per 1000 women under the age of 60 years.[9] Genital prolapse is also a major cause of gynaecological surgery.

Aims of intervention

To relieve symptoms; to remove the vaginal mass; to improve urinary incontinence, poor flow, or urinary retention; to alleviate problems with sexual intercourse (usually related to access or sensation) or emptying the bowel with minimal adverse effects of treatment.

Outcomes

Symptom relief: symptom scores, recurrence of prolapse or persistence of symptoms such as stress incontinence; re-operation; hospital stay/length of operation; quality of life: measured by scores such as the Prolapse Quality-of-Life Questionnaire;[13] and postoperative complications/adverse effects of treatment; postoperative dyspareunia and de novo postoperative stress incontinence.

Methods

Clinical Evidence search and appraisal August 2011. The following databases were used to identify studies for this systematic review: Medline 1966 to August 2011, Embase 1980 to August 2011, and The Cochrane Database of Systematic Reviews 2011, Issue 2. An additional search within The Cochrane Library was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language. We also included cohort studies for the options listed in the first question of this review. Open studies have been included. Studies contain >20 individuals of whom >80% were followed up. The minimum length of follow-up was 1 year. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied applying the same study design criteria for inclusion as we did for benefits. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table.

GRADE Evaluation of interventions for Genital prolapse in women.

Important outcomes	Adverse effects, Hospital stay/length of operation, Postoperative complications, Quality of life, Re-operation, Recurrence of prolapse or persistence of symptoms, Symptom relief
Studies (Participants)	Outcome	Comparison	Type of evidence	Quality	Consistency	Directness	Effect size	GRADE	Comment
What are the effects of non-surgical treatments in women with genital prolapse?
1 (48)	Symptom relief	Vaginal oestrogen versus placebo	4	–3	0	0	0	Very low	Quality points deducted for sparse data, unclear allocation method, and low event rate
1 (45)	Recurrence of prolapse or persistence of symptoms	Vaginal oestrogen versus placebo	4	–2	0	0	0	Low	Quality points deducted for sparse data and unclear allocation method
1 (45)	Postoperative complications	Vaginal oestrogen versus placebo	4	–2	0	0	0	Low	Quality points deducted for sparse data and unclear allocation method
What are the effects of surgical treatments in women with anterior vaginal wall prolapse?
1 (68)	Symptom relief	Traditional anterior colporrhaphy versus abdominal Burch colposuspension	4	–2	0	–1	0	Very low	Quality points deducted for sparse data and randomisation flaws. Directness point deducted for narrow inclusion criteria
1 (68)	Recurrence of prolapse or persistence of symptoms	Traditional anterior colporrhaphy versus abdominal Burch colposuspension	4	–2	0	–1	+2	Moderate	Quality points deducted for sparse data and randomisation flaws. Directness point deducted for narrow inclusion criteria. Effect-size points added for RR <0.2 and RR >2
1 (68)	Re-operation	Traditional anterior colporrhaphy versus abdominal Burch colposuspension	4	–2	0	–1	0	Very low	Quality points deducted for sparse data and randomisation flaws. Directness point deducted for narrow inclusion criteria
1 (68)	Adverse effects	Traditional anterior colporrhaphy versus abdominal Burch colposuspension	4	–2	0	–1	+2	Moderate	Quality points deducted for sparse data and randomisation flaws. Directness point deducted for narrow inclusion criteria. Effect-size points added for RR >5
4 (581)	Symptom relief	Anterior colporrhaphy with mesh or graft reinforcement versus traditional anterior colporrhaphy	4	0	0	–1	0	Moderate	Directness point deducted for restricted population in some RCTs
10 (756)	Recurrence of prolapse or persistence of symptoms	Anterior colporrhaphy with mesh or graft reinforcement versus traditional anterior colporrhaphy	4	0	0	0	0	High
3 (664)	Re-operation	Anterior colporrhaphy with mesh or graft reinforcement versus traditional anterior colporrhaphy	4	–1	0	0	0	Moderate	Quality point deducted for low event rate in some outcomes
1 (76)	Quality of life	Anterior colporrhaphy with mesh or graft reinforcement versus traditional anterior colporrhaphy	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
1 (389)	Hospital stay/length of operation	Anterior colporrhaphy with mesh or graft reinforcement versus traditional anterior colporrhaphy	4	–1	0	0	0	Moderate	Quality point deducted for lack of blinding
11 (1525)	Adverse effects	Anterior colporrhaphy with mesh or graft reinforcement versus traditional anterior colporrhaphy	4	–1	0	0	0	Moderate	Quality point deducted for low event rate for some comparisons
1 (57)	Recurrence of prolapse or persistence of symptoms	Ultralateral anterior colporrhaphy versus traditional anterior colporrhaphy	4	–2	0	0	0	Low	Quality points deducted for sparse data and poor follow-up
1 (74)	Postoperative complications	Ultralateral anterior colporrhaphy versus traditional anterior colporrhaphy	4	–2	0	0	0	Low	Quality points deducted for sparse data and poor follow-up
What are the effects of surgical treatments in women with posterior vaginal wall prolapse?
3 (131)	Symptom relief	Posterior colporrhaphy versus transanal repair	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
2 (87)	Recurrence of prolapse or persistence of symptoms	Posterior colporrhaphy versus transanal repair	4	–1	0	0	+1	High	Quality point deducted for sparse data. Effect-size point added for RR <0.5
2 (87)	Hospital stay/length of operation	Posterior colporrhaphy versus transanal repair	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
2 (87)	Postoperative complications	Posterior colporrhaphy versus transanal repair	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
2 (238)	Recurrence of prolapse or persistence of symptoms	Posterior colporrhaphy with mesh versus posterior colporrhaphy without mesh reinforcement	4	0	0	–1	0	Moderate	Directness point deducted for conflicting results
What are the effects of surgical treatments in women with upper vaginal wall prolapse?
2 (169)	Symptom relief	Abdominal sacral colpopexy versus vaginal sacrospinous colpopexy	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
3 (249)	Recurrence of prolapse or persistence of symptoms	Abdominal sacral colpopexy versus vaginal sacrospinous colpopexy	4	0	0	0	0	High
4 (456)	Re-operation	Abdominal sacral colpopexy versus vaginal sacrospinous colpopexy	4	0	0	–1	0	Moderate	Directness point deducted for composite outcome
3 (293)	Hospital stay/length of operation	Abdominal sacral colpopexy versus vaginal sacrospinous colpopexy	4	0	0	0	0	High
at least 3 (at least 287)	Adverse effects	Abdominal sacral colpopexy versus vaginal sacrospinous colpopexy	4	–1	0	0	0	Moderate	Quality point deducted for incomplete reporting (not reporting types of adverse effects)
1 (82)	Symptom relief	Vaginal hysterectomy and repair (with the vault being fixed to the uterosacral cardinal ligament complex) versus abdominal sacrohysteropexy with uterine preservation	4	–1	0	–1	+1	Moderate	Quality point deducted for sparse data. Directness point deducted for differences in disease state. Effect size point added for RR >2
1 (82)	Re-operation	Vaginal hysterectomy and repair (with the vault being fixed to the uterosacral cardinal ligament complex) versus abdominal sacrohysteropexy with uterine preservation	4	–1	0	–1	+2	High	Quality point deducted for sparse data. Directness point deducted for differences in disease state. Effect-size points added for RR >5
1 (82)	Hospital stay/length of operation	Vaginal hysterectomy and repair (with the vault being fixed to the uterosacral cardinal ligament complex) versus abdominal sacrohysteropexy with uterine preservation	4	–1	0	–1	0	Low	Quality point deducted for sparse data. Directness point deducted for differences in disease state
1 (82)	Adverse effects	Vaginal hysterectomy and repair (with the vault being fixed to the uterosacral cardinal ligament complex) versus abdominal sacrohysteropexy with uterine preservation	4	–2	0	0	0	Low	Quality points deducted for sparse data and for incomplete reporting (not reporting types of adverse effects)
1 (66)	Recurrence of prolapse or persistence of symptoms	Posterior intravaginal slingplasty (infracoccygeal sacropexy) versus vaginal sacrospinous colpopexy	4	–2	0	0	0	Low	Quality points deducted for sparse data and incomplete reporting of results
1 (66)	Hospital stay/length of operation	Posterior intravaginal slingplasty (infracoccygeal sacropexy) versus vaginal sacrospinous colpopexy	4	–2	0	0	0	Low	Quality points deducted for sparse data and incomplete reporting of results
What are the effects of using different surgical materials in women with genital prolapse?
1 (54)	Symptom relief	Different types of suture versus each other	4	–1	0	0	0	Moderate	Quality point deducted for sparse data
1 (49)	Adverse effects	Different types of suture versus each other	4	–1	0	0	0	Moderate	Quality point deducted for sparse data

We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.

Glossary

High-quality evidence

Further research is very unlikely to change our confidence in the estimate of effect.

Low-quality evidence

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.

Moderate-quality evidence

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Traditional anterior colporrhaphy

Mid-line plication without tension suturing.

Ultralateral anterior colporrhaphy

Procedure involving dissection to the pubic rami laterally with plication of paravaginal tissues and tension suturing.

Very low-quality evidence

Any estimate of effect is very uncertain.

See Urinary stress incontinence

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