Urinary incontinence persisting after childbirth: extent, delivery history, and effects in a 12-year longitudinal cohort study.

OBJECTIVE: To investigate the extent of persistent urinary incontinence (UI) 12 years after birth, and association with delivery-mode history and other factors. DESIGN: Twelve-year longitudinal cohort study. SETTING: Maternity units in Aberdeen, Birmingham, and Dunedin. POPULATION: Women who returned questionnaires 3 months and 12 years after index birth. METHODS: Data on all births over a period of 12 months were obtained from the units and then women were contacted by post. MAIN OUTCOME MEASURE: Persistent UI reported at 12 years, with one or more previous contact. RESULTS: Of 7879 women recruited at 3 months, 3763 (48%) responded at 12 years, with 2944 also having responded at 6 years; non-responders had similar obstetric characteristics. The prevalence of persistent UI was 37.9% (1429/3763). Among those who had reported UI at 3 months, 76.4% reported it at 12 years. Women with persistent UI had lower SF12 quality of life scores. Compared with having only spontaneous vaginal deliveries (SVDs), women who delivered exclusively by caesarean section were less likely to have persistent UI (odds ratio, OR 0.42, 95% CI 0.33-0.54). This was not the case in women who had a combination of caesarean section and SVD births (OR 1.01, 95% CI 0.78-1.30). Older age at first birth, greater parity, and overweight/obesity were associated with persistent UI. Of 54 index primiparae with UI before pregnancy, 46 (85.2%) had persistent UI. CONCLUSIONS: This study, demonstrating that UI persists to 12 years in about three-quarters of women, and that risk was only reduced with caesarean section if women had no other delivery mode, has practice implications. TWEETABLE ABSTRACT: A longitudinal study of 3763 women showed a prevalence of persistent UI 12 years after birth of 37.9%.

Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial.

BACKGROUND: Lower urinary tract symptoms (LUTS) comprise storage symptoms, voiding symptoms and post-voiding symptoms. Prevalence and severity of LUTS increase with age and the progressive increase in the aged population group has emphasised the importance to our society of appropriate and effective management of male LUTS. Identification of causal mechanisms is needed to optimise treatment and uroflowmetry is the simplest non-invasive test of voiding function. Invasive urodynamics can evaluate storage function and voiding function; however, there is currently insufficient evidence to support urodynamics becoming part of routine practice in the clinical evaluation of male LUTS. DESIGN: A 2-arm trial, set in urology departments of at least 26 National Health Service (NHS) hospitals in the United Kingdom (UK), randomising men with bothersome LUTS for whom surgeons would consider offering surgery, between a care pathway based on urodynamic tests with invasive multichannel cystometry and a care pathway based on non-invasive routine tests. The aim of the trial is to determine whether a care pathway not including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is included, at 18 months after randomisation. This primary clinical outcome will be measured with the International Prostate Symptom Score (IPSS). We will also establish whether inclusion of invasive urodynamics reduces rates of bladder outlet surgery as a main secondary outcome. DISCUSSION: The general population has an increased life-expectancy and, as men get older, their prostates enlarge and potentially cause benign prostatic obstruction (BPO) which often requires surgery. Furthermore, voiding symptoms become increasingly prevalent, some of which may not be due to BPO. Therefore, as the population ages, more operations will be considered to relieve BPO, some of which may not actually be appropriate. Hence, there is sustained interest in the diagnostic pathway and this trial could improve the chances of an accurate diagnosis and reduce overall numbers of surgical interventions for BPO in the NHS. The morbidity, and therapy costs, of testing must be weighed against the cost saving of surgery reduction. TRIAL REGISTRATION: Controlled-trials.com - ISRCTN56164274 (confirmed registration: 8 April 2014).

Twelve-year follow-up of conservative management of postnatal urinary and faecal incontinence and prolapse outcomes: randomised controlled trial.

OBJECTIVE: To determine the long-term (12-year) effects of a conservative nurse-led intervention for postnatal urinary incontinence. DESIGN: Follow-up of a randomised controlled trial. SETTING: Community-based intervention in three centres (in the UK and New Zealand). POPULATION: A cohort of 747 women with urinary incontinence at 3 months after childbirth, of whom 471 (63%) were followed up after 12 years. METHODS: Women were randomly allocated to active conservative treatment after delivery (pelvic floor muscle training and bladder training), or to a control group receiving standard care. MAIN OUTCOME MEASURES: Prevalence of urinary incontinence (primary outcome) and faecal incontinence, symptoms and signs of prolapse, and performance of pelvic floor muscle training at 12 years. RESULTS: The significant improvements relative to controls that had been found in urinary incontinence (60 versus 69%; risk difference, RD, -9.1%; 95% confidence interval, 95% CI, -17.3 to -1.0%) and faecal incontinence (4 versus 11%; RD -6.1%; 95% CI -10.8 to -1.6%) at 1 year did not persist for urinary incontinence (83 versus 80%; RD 2.1%; 95% CI -4.9 to 9.1%) or faecal incontinence (19 versus 15%; RD 4.3%; 95% CI -2.5 to 11.0%) at the 12-year follow up, irrespective of incontinence severity at trial entry. The prevalence of prolapse symptoms or objectively measured pelvic organ prolapse also did not differ between the groups. In the short term the intervention motivated more women to perform pelvic floor muscle training (83 versus 55%), but this fell in both groups by 12 years (52 versus 49%). CONCLUSIONS: The moderate short-term benefits of a brief nurse-led conservative treatment for postnatal urinary incontinence did not persist. About four-fifths of women with urinary incontinence 3 months after childbirth still had this problem 12 years later.

Childbirth and prolapse: long-term associations with the symptoms and objective measurement of pelvic organ prolapse.

OBJECTIVES: To investigate prolapse symptoms and objectively measured pelvic organ prolapse, 12 years after childbirth, and association with delivery mode history. DESIGN: Twelve-year longitudinal study. SETTING: Maternity units in Aberdeen, Birmingham and Dunedin. POPULATION: Women dwelling in the community. METHODS: Data from women were collected 12 years after an index birth and women were invited for examination. Logistic regression investigated associations between risk factors and prolapse symptoms and signs. MAIN OUTCOME MEASURES: Prolapse symptom score (POP-SS); objectively measured prolapse (POP-Q). RESULTS: Of 7725 continuing women, 3763 (49%) returned questionnaires at 12 years. The median POP-SS score was 2 (IQR 0-4). One or more forceps deliveries (OR 1.20, 95% CI 1.04-1.38) and a body mass index (BMI) over 25 were associated with higher (worse) POP-SS scores, but age over 25 years at first delivery was associated with lower (better) scores. There was no protective effect if all deliveries were by caesarean section (OR 0.84, 95% CI 0.69-1.02). Objective prolapse was found in 182/762 (24%) women. Women aged over 30 years when having their first baby and parity were significantly associated with prolapse. Compared with women whose births were all spontaneous vaginal deliveries, women who had all births by caesarean section were the least likely to have prolapse (OR 0.11, 95% CI 0.03-0.38), and there was a reduced risk after forceps or a mixture of spontaneous vaginal delivery and caesarean section. CONCLUSIONS: These findings are at odds with each other, suggesting that prolapse symptoms and objective prolapse may not be in concordance, or are associated with different antecedent factors. Further follow-up is planned.

Faecal incontinence persisting after childbirth: a 12 year longitudinal study.

OBJECTIVES: To investigate persistent faecal incontinence (FI) 12 years after birth and association with delivery mode history and quality of life. DESIGN: Twelve-year longitudinal study. SETTING: Maternity units in Aberdeen, Birmingham and Dunedin. POPULATION: Women who returned questionnaires 3 months and 12 years after index birth. METHODS: Data on all births over 12 months were obtained from units and women were contacted 3 months, 6 years and 12 years post birth. MAIN OUTCOME MEASURE: Persistent FI, defined as reported at 12 years and one or more previous contacts. SF12 assessed quality of life. RESULTS: Of 7879 women recruited at 3 months, 3763 responded at 12 years, 2944 of whom also responded at 6 years: nonresponders were similar in obstetric factors. Prevalence of persistent FI was 6.0% (227/3763); 43% of 12-year responders who reported FI at 3 months also reported it at 12 years. Women with persistent FI had significantly lower SF12 scores. Compared with only spontaneous vaginal deliveries, women who had one or more forceps delivery were more likely to have persistent FI (odds ratio [OR] 2.08, 95% confidence interval [95% CI] 1.53-2.85) but it was no less likely with exclusively caesarean births (OR 0.93, 95% CI 0.54-1.58). More obese women than normal weight women reported persistent FI (OR 1.52, 95% CI 1.06-2.17). CONCLUSIONS: This longitudinal study has demonstrated persistence of FI many years after birth and shown that one forceps birth increased the likelihood, whereas exclusive caesarean birth showed no association. Obesity, which increased symptom likelihood, is a modifiable risk factor.

Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial).

BACKGROUND: Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital and incurs significant costs for health-care providers such as the UK NHS. Many preventative strategies and measures have been introduced to minimise CAUTI risk, including the use of antimicrobial catheters. However, there is considerable uncertainty regarding their usefulness in terms of reducing symptomatic CAUTI, and whether or not they are cost-effective. OBJECTIVES: Do antimicrobial catheters reduce the rate of symptomatic urinary tract infection (UTI) during short-term hospital use and is their use cost-effective for the UK NHS? DESIGN: A pragmatic multicentre UK randomised controlled trial comparing three catheters as they would be used in the UK NHS: antimicrobial-impregnated (nitrofurazone) and antiseptic-coated (silver alloy) catheters with the standard polytetrafluoroethylene (PTFE)-coated catheters. Economic evaluation used a decision model populated with data from the trial. Sensitivity analysis was used to explore uncertainty. SETTING: Relevant clinical departments in 24 NHS hospitals throughout the UK. PARTICIPANTS: Adults requiring temporary urethral catheterisation for a period of between 1 and 14 days as part of their care, predominantly as a result of elective surgery. INTERVENTIONS: Eligible participants were randomised 1 : 1 : 1 to one of three types of urethral catheter in order to make the following pragmatic comparisons: nitrofurazone-impregnated silicone catheter compared with standard PTFE-coated latex catheter; and silver alloy-coated hydrogel latex catheter compared with standard PTFE-coated latex catheter. MAIN OUTCOME MEASURES: The primary outcome for clinical effectiveness was the incidence of UTI at any time up to 6 weeks post randomisation. This was defined as any symptom reported during catheterisation, up to 3 days or 1 or 2 weeks post catheter removal or 6 weeks post randomisation combined with a prescription of antibiotics, at any of these times, for presumed symptomatic UTI. The primary economic outcome was incremental cost per quality-adjusted life-year (QALY). Health-care costs were estimated from NHS sources with QALYs calculated from participant completion of the European Quality of Life-5 Dimensions (EQ-5D). RESULTS: Outcome analyses encompassed 6394 (90%) of 7102 participants randomised. The rate of symptomatic UTI within 6 weeks of randomisation was 10.6% in the nitrofurazone group (n = 2153; -2.1% absolute risk difference), 12.5% in the silver alloy group (n = 2097; -0.1% absolute risk difference) and 12.6% in the PTFE group (n = 2144). The effect size {odds ratio (OR) [97.5% confidence interval (CI)]} was 0.82 (97.5% CI 0.66 to 1.01) for nitrofurazone (p = 0.037) and 0.99 (97.5% CI 0.81 to 1.22) for silver alloy (p = 0.92) catheters. The nitrofurazone catheters were more likely to cause discomfort during use and on removal. The primary economic analysis suggested that nitrofurazone-impregnated catheters would be, on average, the least costly (> £7 less than PTFE) and most effective option at current NHS prices. There was a 73% chance that nitrofurazone would be cost saving and an 84% chance that the incremental cost per QALY would be < £30,000. At the trial price (£6.46), silver alloy catheters were very unlikely to be cost-effective. These results were unchanged in sensitivity analyses, although when the length of stay cost was excluded the incremental cost per QALY for nitrofurazone against PTFE was £28,602. CONCLUSIONS: The trial estimate of clinical effectiveness for nitrofurazone-impregnated catheters was less than the pre-specified minimum absolute risk difference that we considered important (-3.3%), and the surrounding CI included zero, indicating that any reduction in catheter-associated UTI was uncertain. Economic analysis, although associated with uncertainty, suggested that nitrofurazone-impregnated catheters may be cost-effective for the NHS. The trial ruled out the possibility that silver alloy-coated catheters might reach the pre-set degree of clinical effectiveness and that their use was unlikely to be cost-effective. These findings should be considered by patients, clinicians and health-care policy-makers to determine whether or not a change in practice is worthwhile. Future research should be aimed at determining the minimum clinically important difference in terms of CAUTI prevention in comparative trials, and to identify reliable methods which can detect the impact of the intervention on quality of life and other drivers of cost, when the intervention is a subsidiary part of overall treatment plans.

The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery.

AIMS: The impact of urinary incontinence (UI) on health-related quality of life (HRQoL) has been less well researched in men than women and the general population. This study aims to assess the association between UI and HRQoL in men 1 year after prostate surgery. METHODS: Planned secondary analysis of data from two parallel randomized controlled trials of active conservative treatment for UI in 853 men following radical prostatectomy (RP) and transurethral resection of the prostate (TURP). Men of any age were eligible for trial inclusion if they were experiencing UI 6 weeks after undergoing RP or TURP at 34 centers in the United Kingdom. Univariate and multivariate analysis considered associations between health status (SF-12 and EQ-5D) and self-reported UI. Multivariate analysis controlled for age, obesity, UI prior to surgery, and concomitant fecal incontinence. RESULTS: Mean age of 411 men in the RP trial was 62.3 years (SD 5.7) and 442 men in the TURP trial was 68.0 (SD 7.9). Of men with UI at 6 weeks after surgery, 76.7% in the RP group and 63.2% in the TURP group still had UI at 12 months. Any UI at 12 months was significantly associated with reduced HRQoL in the RP group and lower EQ-5D and SF-12 Mental Component Scores in the TURP group. CONCLUSION: Any UI is a significant factor in reduced HRQoL in men following prostate surgery, particularly younger men who undergo RP. Its importance to patients as an adverse outcome should not be underestimated.

A randomised controlled trial evaluating the use of polyglactin (Vicryl) mesh, polydioxanone (PDS) or polyglactin (Vicryl) sutures for pelvic organ prolapse surgery: outcomes at 2 years.

The effects at 2 years of polyglactin (Vicryl) mesh inlay and polydioxanone (PDS) or polyglactin (Vicryl) suture material on prolapse symptoms, urinary, bowel, sexual function and prolapse related Quality-of-Life (QoL) in women undergoing pelvic organ prolapse surgery were evaluated in a randomised controlled trial with a 2 × 2 factorial design of Vicryl mesh (n = 32) or not (n = 34) and PDS (n = 33) or Vicryl suture (n = 33). The response rate at 2 years was 82%. There were no differences in the prolapse symptom scores between the randomised groups. Prolapse-related QoL score (mean difference: 2.05, 95% CI 0.19-3.91) and urinary incontinence score (mean difference: 2.56, 95% CI 0.02-5.11) were significantly lower (better) in women who had Vicryl compared with PDS sutures. The apparent superiority of the prolapse-related QoL and urinary incontinence scores in women using Vicryl suture material (vs PDS) needs to be confirmed in a larger trial.

Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials.

OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of active conservative treatment, compared with standard management, in regaining urinary continence at 12 months in men with urinary incontinence at 6 weeks after a radical prostatectomy or a transurethral resection of the prostate (TURP). BACKGROUND: Urinary incontinence after radical prostate surgery is common immediately after surgery, although the chance of incontinence is less after TURP than following radical prostatectomy. DESIGN: Two multicentre, UK, parallel randomised controlled trials (RCTs) comparing active conservative treatment [pelvic floor muscle training (PFMT) delivered by a specialist continence physiotherapist or a specialist continence nurse] with standard management in men after radial prostatectomy and TURP. SETTING: Men having prostate surgery were identified in 34 centres across the UK. If they had urinary incontinence, they were invited to enroll in the RCT. PARTICIPANTS: Men with urinary incontinence at 6 weeks after prostate surgery were eligible to be randomised if they consented and were able to comply with the intervention. INTERVENTIONS: Eligible men were randomised to attend four sessions with a therapist over a 3-month period. The therapists provided standardised PFMT and bladder training for male urinary incontinence and erectile dysfunction. The control group continued with standard management. MAIN OUTCOME MEASURES: The primary outcome of clinical effectiveness was urinary incontinence at 12 months after randomisation, and the primary measure of cost-effectiveness was incremental cost per quality-adjusted life-year (QALY). Outcome data were collected by postal questionnaires at 3, 6, 9 and 12 months. RESULTS: Within the radical group (n = 411), 92% of the men in the intervention group attended at least one therapy visit and were more likely than those in the control group to be carrying out any PFMT at 12 months {adjusted risk ratio (RR) 1.30 [95% confidence interval (CI) 1.09 to 1.53]}. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (75.5%) and control (77.4%) groups was -1.9% (95% CI -10% to 6%). NHS costs were higher in the intervention group [£ 181.02 (95% CI £ 107 to £ 255)] but there was no evidence of a difference in societal costs, and QALYs were virtually identical for both groups. Within the TURP group (n = 442), over 85% of men in the intervention group attended at least one therapy visit and were more likely to be carrying out any PFMT at 12 months after randomisation [adjusted RR 3.20 (95% CI 2.37 to 4.32)]. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (64.9%) and control (61.5%) groups for the unadjusted intention-to-treat analysis was 3.4% (95% CI -6% to 13%). NHS costs [£ 209 (95% CI £ 147 to £ 271)] and societal costs [£ 420 (95% CI £ 54 to £ 785)] were statistically significantly higher in the intervention group but QALYs were virtually identical. CONCLUSIONS: The provision of one-to-one conservative physical therapy for men with urinary incontinence after prostate surgery is unlikely to be effective or cost-effective compared with standard care that includes the provision of information about conducting PFMT. Future work should include research into the value of different surgical options in controlling urinary incontinence.

Exclusive caesarean section delivery and subsequent urinary and faecal incontinence: a 12-year longitudinal study.

OBJECTIVES: To investigate the association between delivery mode history and urinary and faecal incontinence, specifically a history of exclusive caesarean section deliveries. DESIGN: Twelve-year longitudinal study. SETTING: Maternity units in Aberdeen, Birmingham and Dunedin. POPULATION: Women who returned postal questionnaires 3 months and 12 years after index birth. METHODS: Data on all births over a 12-month period were obtained from units and women were followed 3 months, 6 years and 12 years after the birth. MAIN OUTCOME MEASURES: Urinary incontinence (UI) and faecal incontinence (FI) 12 years after index birth. RESULTS: Of the 7883 women recruited at 3 months, 3763 were followed up at 12 years: nonresponders were similar in their obstetric factors. After adjustment for parity, body mass index and age at first birth, women who delivered exclusively by caesarean section were less likely to have UI than those who only had spontaneous vaginal births (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.37-0.58), but not if they had a combination of caesarean and spontaneous vaginal births (OR 1.14, 95% CI 0.89-1.47). There was no difference in FI among women who had exclusive caesarean births (OR 0.94, 95% CI 0.66-1.33) or mixed caesarean and spontaneous vaginal births (OR 1.06, 95% CI 0.73-1.54). CONCLUSIONS: Unless women are resolved to have all their deliveries by the abdominal route (and their medical advisors agree), caesarean section does not protect from subsequent UI. Even among those who do deliver exclusively by caesarean section, 40% still report UI; and this strategy confers no benefit for subsequent FI.

Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence (SUI) through systematic review and economic modelling. DATA SOURCES: The Cochrane Incontinence Group Specialised Register, electronic databases and the websites of relevant professional organisations and manufacturers, and the following databases: CINAHL, EMBASE, BIOSIS, Science Citation Index and Social Science Citation Index, Current Controlled Trials, ClinicalTrials.gov and the UKCRN Portfolio Database. STUDY SELECTION: The study comprised three distinct elements. (1) A survey of 188 women with SUI to identify outcomes of importance to them (activities of daily living; sex, hygiene and lifestyle issues; emotional health; and the availability of services). (2) A systematic review and meta-analysis of non-surgical treatments for SUI to find out which are most effective by comparing results of trials (direct pairwise comparisons) and by modelling results (mixed-treatment comparisons - MTCs). A total of 88 randomised controlled trials (RCTs) and quasi-RCTs reporting data from 9721 women were identified, considering five generic interventions [pelvic floor muscle training (PFMT), electrical stimulation (ES), vaginal cones (VCs), bladder training (BT) and serotonin-noradrenaline reuptake inhibitor (SNRI) medications], in many variations and combinations. Data were available for 37 interventions and 68 treatment comparisons by direct pairwise assessment. Mixed-treatment comparison models compared 14 interventions, using data from 55 trials (6608 women). (3) Economic modelling, using a Markov model, to find out which combinations of treatments (treatment pathways) are most cost-effective for SUI. DATA EXTRACTION: Titles and abstracts identified were assessed by one reviewer and full-text copies of all potentially relevant reports independently assessed by two reviewers. Any disagreements were resolved by consensus or arbitration by a third person. RESULTS: Direct pairwise comparison and MTC analysis showed that the treatments were more effective than no treatment. Delivering PFMT in a more intense fashion, either through extra sessions or with biofeedback (BF), appeared to be the most effective treatment [PFMT extra sessions vs no treatment (NT) odds ratio (OR) 10.7, 95% credible interval (CrI) 5.03 to 26.2; PFMT + BF vs NT OR 12.3, 95% CrI 5.35 to 32.7]. Only when success was measured in terms of improvement was there evidence that basic PFMT was better than no treatment (PFMT basic vs NT OR 4.47, 95% CrI 2.03 to 11.9). Analysis of cost-effectiveness showed that for cure rates, the strategy using lifestyle changes and PFMT with extra sessions followed by tension-free vaginal tape (TVT) (lifestyle advice-PFMT extra sessions-TVT) had a probability of greater than 70% of being considered cost-effective for all threshold values for willingness to pay for a QALY up to 50,000 pounds. For improvement rates, lifestyle advice-PFMT extra sessions-TVT had a probability of greater than 50% of being considered cost-effective when society's willingness to pay for an additional QALY was more than 10,000 pounds. The results were most sensitive to changes in the long-term performance of PFMT and also in the relative effectiveness of basic PFMT and PFMT with extra sessions. LIMITATIONS: Although a large number of studies were identified, few data were available for most comparisons and long-term data were sparse. Challenges for evidence synthesis were the lack of consensus on the most appropriate method for assessing incontinence and intervention protocols that were complex and varied considerably across studies. CONCLUSIONS: More intensive forms of PFMT appear worthwhile, but further research is required to define an optimal form of more intensive therapy that is feasible and efficient for the NHS to provide, along with further definitive evidence from large, well-designed studies.

Measuring outcomes of importance to women with stress urinary incontinence.

OBJECTIVE: To provide evidence on outcomes of importance to women who have stress urinary incontinence (SUI). The secondary aim was to identify additional outcomes that ought to be collected in future primary studies or in systematic reviews of the literature. DESIGN: Questionnaire survey of a cohort of women with SUI. SETTING: UK. SAMPLE: A total of 188 women with SUI. METHODS: Areas of importance to women who suffer from SUI were assessed using a patient generated index (PGI). In addition to the PGI, the questionnaire included the King's Health Questionnaire (KHQ) and the EuroQol-5D (EQ-5D). MAIN OUTCOME MEASURES: PGI, EQ-5D and the KHQ. RESULTS: In total, 38 different areas were reported by respondents on the PGI. PGI and EQ-5D scores were positively correlated and significant. Correlations between the seven domains of the KHQ and PGI were all negative, but only two were statistically significant: personal relationships and severity measures. CONCLUSIONS: The PGI succeeded in capturing a diverse range of outcomes of importance to women suffering with SUI. Given the limited correlation between the KHQ domains and the PGI and, in addition, that the areas mentioned in the PGI were not found to map well to the EQ-5D, the PGI in this instance may be capturing concerns of women who suffer from SUI, which are not captured by quality-of-life measures such as the EQ-5D.

Psychometric properties of the pelvic organ prolapse symptom score.

OBJECTIVE: To assess the internal consistency, construct validity and sensitivity to change of a pelvic organ prolapse symptom score (POP-SS). DESIGN: Analysis of data from three prolapse studies, including symptomatic and asymptomatic women who completed the POP-SS. SETTING: (1) A community setting in New Zealand, (2) two gynaecology outpatient departments in Scotland and (3) a gynaecological surgery department in Scotland. POPULATION OR SAMPLE: (1) Participants from a survey of postnatal women at 12-year follow up, invited to complete a prolapse questionnaire and have prolapse assessment, (2) new gynaecology outpatients presenting with prolapse symptoms, randomised to pelvic floor muscle training (PFMT) or control and (3) women having anterior and/or posterior prolapse surgery, randomised to mesh insert or no mesh. METHOD: Data were analysed to assess internal consistency, construct validity and sensitivity to change of the POP-SS. MAIN OUTCOME MEASURES: Cronbach's alpha, significance of differences in POP-SS scores between studies and significance of difference in POP-SS scores pre- to post-intervention. RESULTS: For internal consistency, Cronbach's alpha ranged from 0.723 to 0.828. Women having surgery had higher POP-SS scores than those having conservative management (mean difference 5.0, 95% CI 3.1-6.9), who in turn had higher scores than the asymptomatic women (mean difference 5.9, 95% CI 4.4-7.4). Significant differences in POP-SS score were detected after surgery and PFMT. The improvement due to surgery was significantly greater than that associated with PFMT (z =-3.006, P = 0.003). CONCLUSION: The POP-SS has good internal consistency and construct validity and is sensitive to change.

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), nonrandomised 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 1-51 months). 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). Nonabsorbable 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 absorbable 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. CONCLUSIONS: 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.

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 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<0.01] and shorter operative time, of uncertain practical significance. It may also offer a shorter recovery period and greater patient satisfaction. Evidence on long-term outcomes (especially revision) is too limited to be useful. Lack of data prevented subgroup analysis. With respect to the two-incision approach, data were suggestive of shorter recovery compared with single-incision THR, but conclusions must be treated with caution. The costs to the health service, per patient, of single mini-incision THR depend upon assumptions made, but are similar at one year (7060 pounds sterling vs 7350 pounds sterling for standard THR). For a 40-year time horizon the costs were 11,618 pounds sterling for mini-incision and 11,899 pounds sterling for standard THR. Two existing economic evaluations were identified, but they added little, if any, value to the current evidence base owing to their limited quality. In the economic model, mini-incision THR was less costly and provided slightly more QALYs in both the 1- and 40-year analyses. The mean QALYs at 1 year were 0.677 for standard THR and 0.695 for mini-incision THR. At 40 years, the mean QALYs were 8.463 for standard THR and 8.480 for mini-incision. At 1 year the probabilistic sensitivity analyses indicate that mini-incision THR has a 95% probability of being cost-effective if society's willingness to pay for a QALY were up to 50,000 pounds sterling. This is reduced to approximately 55% for the 40-year analysis. The results were driven by the assumption of a 1-month earlier return to usual activities and a decreased hospital length of stay and operation duration following mini-incision THR. If mini-incision THR actually required more intensive use of resources it would become approximately 200 pounds sterling more expensive and would only be cost-effective (cost per QALY>30,000 pounds sterling) 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.

Sacral nerve stimulation for fecal incontinence and constipation in adults: a short version Cochrane review.

BACKGROUND: Fecal incontinence and constipation are disabling conditions that reduce quality of life. If conservative treatment fails, one option is sacral nerve stimulation (SNS), a minimally invasive technique allowing modulation of the nerves and muscles of the pelvic floor and hindgut. OBJECTIVES: To assess the effects of SNS for fecal incontinence and constipation in adults. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialized Trials Register (searched 24 April 2007) and the reference lists of relevant articles. SELECTION CRITERIA: All randomized or quasi-randomized trials assessing the effects of SNS for fecal incontinence or constipation in adults. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results, assessed the methodological quality of the included studies, and undertook data extraction. MAIN RESULTS: Three crossover studies were included. Two, enrolling 34 (Leroi) and two participants (Vaizey), assessed the effects of SNS for fecal incontinence, and one (Kenefick), enrolling two participants, assessed SNS for constipation. In the study by Leroi, following the crossover period, participants, while still blinded, chose the period of stimulation they had preferred. Outcomes at different time points were reported separately for 19 participants who preferred the "on" and five who preferred the "off" period. For the group of 19, the median (range) episodes of fecal incontinence per week fell from 1.7 (0-9) during the "off" period to 0.7 (0-5) during the "on" period; for the group of five, however, the median (range) rose from 1.7 (0-11) during the "off" period compared with 3.7 (0-11) during the "on" period. Vaizey reported an average of six, and one, episodes of fecal incontinence per week during the "off" and "on" periods, respectively. Leroi reported that four of 27 participants experienced an adverse event resulting in removal of the stimulator; Vaizey did not report adverse events. For SNS for constipation, during the "off" crossover period the participants experienced an average of two bowel movements per week, compared with five during the "on" period. Abdominal pain and bloating occurred 79% of the time during the "off" period compared with 33% during the "on" period. No adverse events occurred. AUTHORS' CONCLUSIONS: The very limited evidence from the included studies suggests that SNS can improve continence in selected people with fecal incontinence, and reduce symptoms in selected people with constipation. However, temporary, percutaneous stimulation for a 2-3-week period does not always successfully identify those for whom a permanent implant will be beneficial. Larger, good quality randomized crossover trials are needed to allow the effects of SNS for these conditions to be assessed with more certainty.

Surgical management of pelvic organ prolapse in women: a short version Cochrane review.

BACKGROUND: Pelvic organ prolapse may occur in up to 50% of parous women. A variety of urinary, bowel and sexual symptoms may be associated with prolapse. OBJECTIVES: To determine the effects of the many different surgeries in the management of pelvic organ prolapse. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 3 May 2006) and reference lists of relevant articles. We also contacted researchers in the field. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that included surgical operations for pelvic organ prolapse. DATA COLLECTION AND ANALYSIS: Trials were assessed and data extracted independently by two reviewers. Six investigators were contacted for additional information with five responding. MAIN RESULTS: Twenty two randomised controlled trials were identified evaluating 2368 women. Abdominal sacral colpopexy was better than vaginal sacrospinous colpopexy in terms of a lower rate of recurrent vault prolapse (RR 0.23, 95% CI 0.07 to 0.77) and less dyspareunia (RR 0.39, 95% CI 0.18 to 0.86), but the trend towards a lower re-operation rate for prolapse following abdominal sacrocolpopexy was not statistically significant (RR 0.46, 95% CI 0.19 to 1.11). However, the vaginal sacrospinous colpopexy was quicker and cheaper to perform and women had an earlier return to activities of daily living. The data were too few to evaluate other clinical outcomes and adverse events. The three trials contributing to this comparison were clinically heterogeneous. For the anterior vaginal wall prolapse, standard anterior repair was associated with more recurrent cystoceles than when supplemented by polyglactin mesh inlay (RR 1.39, 95% CI 1.02 to 1.90) or porcine dermis mesh inlay (RR 2.72, 95% CI 1.20 to 6.14), but data on morbidity, other clinical outcomes and for other mesh or graft materials were too few for reliable comparisons. For posterior vaginal wall prolapse, the vaginal approach was associated with a lower rate of recurrent rectocele and/or enterocele than the transanal approach (RR 0.24, 95% CI 0.09 to 0.64), although there was a higher blood loss and postoperative narcotic use. However, data on the effect of surgery on bowel symptoms and the use of polyglactin mesh inlay or porcine small intestine graft inlay on the risk of recurrent rectocele were insufficient for meta-analysis.Meta-analysis on the impact of pelvic organ prolapse surgery on continence issues was limited and inconclusive, although about 10% of women developed new urinary symptoms after surgery. Although the addition of tension-free vaginal tape to endopelvic fascia plication (RR 5.5, 95% CI 1.36 to 22.32) and Burch colposuspension to abdominal sacrocolpopexy (RR 2.13, 95% CI 1.39 to 3.24) were followed by a lower risk of women developing new postoperative stress incontinence, but other outcomes, particularly economic, remain to be evaluated. AUTHORS' CONCLUSIONS: Abdominal sacrocolpopexy is associated with a lower rate of recurrent vault prolapse and dyspareunia than the vaginal sacrospinous colpopexy. These benefits must be balanced against a longer operating time, longer time to return to activities of daily living and increased cost of the abdominal approach. The use of mesh or graft inlays at the time of anterior vaginal wall repair may reduce the risk of recurrent cystocele. Posterior vaginal wall repair may be better than transanal repair in the management of rectoceles in terms of recurrence of prolapse. The addition of a continence procedure to a prolapse repair operation may reduce the incidence of postoperative urinary incontinence but this benefit needs to be balanced against possible differences in costs and adverse effects. Adequately powered randomised controlled clinical trials are urgently needed.