A randomised controlled trial evaluating the use of polyglactin mesh, polydioxanone and polyglactin sutures for pelvic organ prolapse surgery

To compare the effectiveness of polyglactin mesh, and polydioxanone or polyglactin sutures in women having pelvic organ prolapse surgery. Randomised controlled trial with a factorial 2(2 design of polyglactin mesh or not, and polydioxanone or polyglactin suture. Outcomes were assessed using questionnaires at baseline and on the third day and at 6 months after surgery. Women were also examined clinically 3 months after surgery. The primary outcome was the subjective improvement in prolapse symptoms and quality of life scores from baseline to 6 months. There was a subjective improvement in the prolapse symptom score from baseline to 6 months after surgery (mean difference of 9.2 (95% CI for difference 7.2-11.2, p < 0.001) and an improvement in the mean quality of life score over the same period with a reduction of 3.4 (95% CI for difference 2.4-4.3, p < 0.001). However, there were no significant differences in the mean difference in prolapse symptoms and quality of life (QoL) scores according to the randomised groups. The majority (86%) of women were satisfied with their surgery. Our study demonstrated that at short-term follow-up, there was no significant difference in the mean differences in prolapse symptoms and QoL scores after surgery using polyglactin mesh or not, polyglactin or polyglactin sutures, but the numbers were too small for a definitive conclusion. Longer-term follow-up and/or a larger trial are required

A randomised controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse

Abstract Forty-seven women participated in a pilot study for a multi-centre randomized controlled trial of the effectiveness of pelvic floor muscle training (PFMT) for women with prolapse. Women with symptomatic stage I or II prolapse [measured by Pelvic Organ Prolapse Quantification (POP-Q)] were randomized to a 16-week physiotherapy intervention (PFMT and lifestyle advice; n=23) or a control group receiving a lifestyle advice sheet (n=24). Symptom severity and quality of life were measured via postal questionnaires. Blinded POP-Q was performed at baseline and follow-up. Intervention women had significantly greater improvement than controls in prolapse symptoms (mean score decrease 3.5 versus 0.1, p=0.021), were significantly more likely to have an improved prolapse stage (45% versus 0%, p=0.038) and were significantly more likely to say their prolapse was better (63% versus 24%, p=0.012). The data support the feasibility of a substantive trial of PFMT for prolapse. A multi-centre trial is underway.This study was funded by the Chief Scientist Office, Scottish Government (CZH/4/95)

Sexual function, delivery mode history, pelvic floor muscle exercises and incontinence : a cross-sectional study six years postpartum

Background: There is controversy over the effect of mode of delivery, pelvic floor muscle exercises (PFME), incontinence and sexual function. Aim: To investigate the relationship of sexual function with delivery mode history, PFMEs and incontinence. Methods: This was a cross-sectional postal survey of women, six years post-partum, who had given birth in maternity units in Aberdeen, Birmingham and Dunedin and had answered a previous questionnaire. Each sexual function question was analysed separately by ANOVA. Results: At six years post-index delivery, 4214 women responded, of whom 2765 (65%) answered the optional ten sexual function questions. Although there was little association between delivery mode history and most sexual function questions, women who had delivered exclusively by caesarean section scored significantly better on the questions relating to their perception of vaginal tone for their own (P-value < 0.0001) and partner's (P-value 0.002) sexual satisfaction, especially when compared with women who had had vaginal and instrumental deliveries. Women who reported that they were currently performing PFME scored significantly better on seven questions. Women with urinary or faecal incontinence scored significantly poorer on all sexual function questions. Conclusions: Mode of delivery history appeared to have minimal effect on sexual function. Current PFME performance was positively associated with most aspects of sexual function, however, all aspects were negatively associated with urinary and faecal incontinence.The original study was supported by Wellbeing and the Health Research Council of New Zealand and the follow-up study by the Health Services Research Unit, which is core funded by a grant from the Chief Scientist Office of the Scottish Executive Health Department

New postnatal urinary incontinence: obstetric and other risk factors in primparae.

Objective To identify obstetric and other risk factors for urinary incontinence which occurs during pregnancy or after childbirth. Design Questionnaire survey of women. Setting Maternity units in Aberdeen (Scotland), Birmingham (England) and Dunedin (New Zealand). Population 3405 primiparous women with singleton births delivered during one year. Methods Questionnaire responses and obstetric casenote data were analysed using multivariate analysis to identify associations with urinary incontinence. Main outcome measures Urinary incontinence at three months after delivery first starting in pregnancy or after birth. Results The prevalence of urinary incontinence was 29%. New incontinence first beginning after delivery was associated with higher maternal age (oldest versus youngest group, odds ratio, OR 2.02, 95% CI 1.35 to 3.02); and method of delivery (caesarean section versus spontaneous vaginal delivery, OR 0.28, 95% CI 0.19 to 0.41). There were no significant associations with forceps delivery (OR 1.18, 95% CI 0.92 to 1.51) or vacuum delivery (OR 1.16, 95% CI 0.83 to 1.63). Incontinence first occurring during pregnancy and still present at three months was associated with higher maternal body mass index (BMI > 25, OR 1.68, 95% CI 1.16 to 2.43), and heavier babies (birthweight in top quartile, OR 1.56, 95% CI 1.12 to 2.19). In these women, caesarean section was associated with less incontinence (OR 0.39, 95% CI 0.27 to 0.58) but incontinence was not associated with age. Conclusions Women have less urinary incontinence after a first delivery by caesarean section whether or not that first starts during pregnancy. Older maternal age was associated with new postnatal incontinence, and higher body mass index and heavier babies with incontinence first starting during pregnancy. The effect of further deliveries may modify these findings

Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis.

Background The efficacy and safety of mesh/graft in surgery for anterior or posterior pelvic organ prolapse is uncertain. Objectives To systematically review the efficacy and safety of mesh/graft for anterior or posterior vaginal wall prolapse surgery. Search strategy Electronic databases and conference proceedings were searched, experts and manufacturers contacted and reference lists of retrieved papers scanned. Selection criteria Randomised controlled trials (RCTs), non-randomised comparative studies, registries, case series involving at least 50 women, and RCTs published as conference abstracts from 2005 onwards. Data collection and analysis One reviewer screened titles/abstracts, undertook data extraction, and assessed study quality. Data analysis was conducted for three subgroups: anterior, posterior, and anterior and/or posterior repair (not reported separately). Results Forty-nine studies involving 4569 women treated with mesh/graft were included. Study quality was generally high. Median follow up was 13 months (range 1 to 51). In anterior repair, there was short-term evidence that mesh/graft (any type) significantly reduced objective prolapse recurrence rates compared with no mesh/graft (relative risk 0.48, 95% CI 0.32-0.72). Non-absorbable synthetic mesh had a significantly lower objective prolapse recurrence rate (8.8%, 48/548) than absorbable synthetic mesh (23.1%, 63/273) and biological graft (17.9%, 186/1041), but a higher erosion rate (10.2%, 68/666) than synthetic mesh (0.7%, 1/147) and biological graft (6.0%, 35/581). There was insufficient information to compare any of the other outcomes regardless of prolapse type. Conclusion Evidence for most outcomes was too sparse to provide meaningful conclusions. Rigorous long-term RCTs are required to determine the comparative efficacy of using mesh/graft.The National Institute for Health and Clinical Excellence Interventional Procedures Programme

Developing a pelvic floor muscle training regimen for use in a trial intervention

This paper explains the rationale behind the intervention used for a large multi centred randomised controlled trial for men following transurethral resection of prostate or radical prostatectomy. It shows the content of the protocol used and explains why this particular protocol of pelvic floor muscle exercises and urge suppression techniques was chosen for men in the intervention group. The trial will evaluate whether this intervention will be effective for men with urinary incontinence and sexual dysfunction after prostate surgery.University of Aberdee

Incontinence-specific quality of life measures used in trials of treatments for female urinary incontinence: a systematic review.

This systematic review examined the use of incontinence-specific QOL measures in clinical trials of female incontinence treatments, and systematically evaluated their quality using a standard checklist. Of 61 trials included in the review, 58 (95.1%) used an incontinence-specific QOL measure. The most commonly used were IIQ (19 papers), I-QoL (12 papers) and UDI (9 papers). Eleven papers (18.0%) used measures which were not referenced or were developed specifically for the study. The eight QOL measures identified had good clinical face validity and measurement properties. We advise researchers to evaluate carefully the needs of their specific study, and select the QOL measure that is most appropriate in terms of validity, utility and relevance, and discourage the development of new measures. Until better evidence is available on the validity and comparability of measures, we recommend that researchers consider using IIQ or I-QOL with or without UDI in trials of incontinence treatments

Systematic review of the clinical effectiveness and cost-effectiveness and economic modelling of minimal incision total hip replacement approaches in the management of arthritic disease of the hip

Objectives: To assess the clinical effectiveness and cost-effectiveness of minimal incision approaches to total hip replacement (THR) for arthritis of the hip. Data sources: Major electronic databases were searched from 1966 to 2007. Relevant websites were also examined and experts in the field were consulted. Review methods: Studies of minimal (one or two) incision THR compared with standard THR were assessed for inclusion in the review of clinical effectiveness. A systematic review of economic evaluations comparing a minimal incision approach to standard THR was also performed and the estimates from the systematic review of clinical effectiveness were incorporated into an economic model. Utilities data were sourced to estimate quality-adjusted life-years (QALYs). Due to lack of data, no economic analysis was conducted for the two mini-incision surgical method. Results: Nine randomised controlled trials (RCTs), 17 non-randomised comparative studies, six case series and one registry were found to be useful for the comparison of single mini-incision THR with standard THR. One RCT compared two mini-incision THR with standard THR, and two RCTs, five non-randomised comparative studies and two case series compared two mini-incision with single mini-incision THR. The RCTs were of moderate quality. Most had fewer than 200 patients and had a follow-up period of less than 1 year. The single mini-incision THR may have some perioperative advantages, e.g. blood loss [weighted mean difference (WMD) –57.71 ml, p £30,000) if recovery was 1.5 weeks faster. A threshold analysis around risk of revision showed, using the same cost per QALY threshold, mini-incision THR would have to have no more than a 7.5% increase in revisions compared with standard THR for it to be no longer considered cost-effective (one more revision for every 200 procedures performed). Further sensitivity analysis involved relaxing assumptions of equal long-term outcomes where possible. and broadly similar results to the base-case analysis were found in this and further sensitivity analyses. Conclusions: Compared with standard THR, minimal incision THR has small perioperative advantages in terms of blood loss and operation time. It may offer a shorter hospital stay and quicker recovery. It appears to have a similar procedure cost to standard THR, but evidence on its longer term performance is very limited. Further long-term follow-up data on costs and outcomes including analysis of subgroups of interest to the NHS would strengthen the current economic evaluation.The Health Services Research Unit and the Health Economics Research Unit are both core funded by the Chief Scientist Office of the Scottish Government Health Directorates.Peer reviewedPublisher PD