Defining nocturnal polyuria in women.

AIMS: Nocturnal polyuria (NP) is defined by the International Continence Society (ICS) as "excessive production of urine during the main sleep period" and is one of the main causes of nocturia. The ICS recognized that "excessive" is not clearly defined and that this needs to be highlighted in both clinical and research settings. The aim of this study was to identify different definitions of NP and apply them to a population of women attending the Urogynaecology clinic. METHODS: This was a retrospective study of complete bladder diaries collected from women attending a tertiary Urogynaecology Unit. Six different definitions were identified and were divided into "absolute," "relative," and "functional definitions." Prevalence data were calculated and values generated for sensitivity, specificity, positive and negative predictive values when related to women voiding ≥ 2 times per night. RESULTS: Complete bladder diaries were obtained from 1398 women, over 6 years, with a mean age of 57 years. Prevalence varied across the definitions from 21.5% (absolute definition) to 77% (relative definition). Sensitivity ranged from 43% (absolute) to 87% (relative). The definitions that showed the highest combined sensitivity and specificity were the functional definitions. CONCLUSION: From this study it is clear that more work needs to be done to arrive at a consensus for defining NP to enable accurate diagnosis and development of treatment pathways. We propose that a relative definition may provide a more clinically relevant method of defining NP.

Botulinum injections for myofascial pelvic pain.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess the impact of botulinum toxin injection in women with myofascial pelvic pain (MFPP) syndrome of the pelvic floor who had failed conservative treatment. METHODS: This was a retrospective descriptive observational study of 48 consecutive patients receiving botulinum toxin to the pelvic floor for MFPP syndrome in a tertiary teaching hospital over an 8-year period. Trigger points were identified, and botulinum toxin was injected into the pelvic floor at the trigger points in doses ranging from 50 to 200 units. The patient-reported global impression of improvement scale was used to evaluate the success at follow-up, and adverse effects were recorded. RESULTS: Forty-six women attended for follow-up at 3-6 months. Of these, 34 (74%) reported an improvement in their symptoms (slightly better, much better, very much better), 12 (26%) had no change, and no patients reported worsening of symptoms. One patient (2%) reported transient postoperative faecal incontinence, which resolved after 2 weeks. There appeared to be no difference in outcome between the doses. CONCLUSIONS: Botulinum toxin injection into the pelvic floor of women with MFPP appears to be beneficial in those who have failed conservative treatment. Prospective studies, including dose-finding studies, are now required.

Minimum standards for reporting outcomes of surgery in urogynaecology.

INTRODUCTION AND HYPOTHESIS: The IUGA special interest group (SIG) identified a need for a minimum data set (MDS) to inform outcome measurements to be included and simplify data capture and standardise reporting for data collection systems. To define a minimum data set for urogynaecological surgical registries. METHODS: Existing registries provide an inventory of items. A modified Delphi approach was used to identify a MDS. At each stage reviewers ranked data points and used free text to comment. The rating used a scale of 0-10 at each review and a traffic light system rated the scores as desirable, highly desirable and mandatory. The scores were collated and reported back to clinicians prior to the further rounds. Outliers were highlighted and reviewers re-assessed prior to repeating the process. A comparison of the MDS was made with published outcomes. RESULTS: Reviewers were from the outcome SIG with emphasis on widespread representation. Fifteen clinicians from eight countries were involved. Four reviewers dissected the existing databases. Eighty data points were considered in four categories, background, preoperative, intraoperative and postoperative. Consensus was reached by the third round. Two points were added on review (date of surgery and urodynamics). Three background points, five preoperative points, seven intraoperative points and nine postoperative points were identified giving 24 minimum data points in the final recommendation. CONCLUSIONS: An MDS has been developed for urogynaecological surgical registries. These should be mandatory points which then allow larger varying points to be assessed. These points correspond well to data points used in published papers from established databases.

An analysis of 1386 periurethral bulking procedures with comparison to 18,763 retropubic tapes.

OBJECTIVE: To use British Society of Urogynaecology surgical database to evaluate periurethral bulking agents and retropubic tapes. STUDY DESIGN: Permission was granted to analyse 1386 periurethral bulking agents and 18,763 retropubic tapes. The primary outcome measure was patient reported global impression of improvement for incontinence with secondary outcomes of change in symptoms of stress incontinence, overactive bladder and complications. RESULTS: Patients undergoing periurethral bulking agents were older than retropubic tapes (mean 59.4 vs. 52.3 years). Urodynamic stress incontinence was the commonest urodynamic diagnosis (periurethral bulking agents 67%, retropubic tapes 77%) but there was a higher proportion of complex diagnoses in the periurethral bulking agents group. 59.2% patients reported 'very much/much better' on patient reported global impression of improvement for incontinence for periurethral bulking agents compared to 91% for retropubic tapes; 28% patients felt their symptoms of stress incontinence were cured following periurethral bulking agents compared to 77.6% for retropubic tapes and 0.8% developed de novo overactive bladder following periurethral bulking agents compared to 4% with retropubic tapes. There was no difference in outcomes when using periurethral bulking agents as a primary or secondary procedure. There were no intraoperative complications with periurethral bulking agents and fewer post-operative complications compared to retropubic tapes (3.6%). CONCLUSION: Patient reported success of periurethral bulking agents is lower than retropubic tapes but this is offset by minimal complications despite being an older, more complex patient group. Periurethral bulking agents do appear equally efficacious as a secondary procedure. Information derived from databases can be used during counselling to allow clinicians to demonstrate their own success and complication rates to ensure patients make an informed choice. Patient choice is paramount so all options should be included in full counselling.

Effect of oestrogen therapy on faecal incontinence in postmenopausal women: a systematic review.

INTRODUCTION AND HYPOTHESIS: Faecal incontinence (FI) is prevalent in postmenopausal women. Oestrogen receptors have been identified in the anal sphincter and have been implicated in the pathogenesis and potential treatment. We sought to evaluate the literature regarding the impact of local and systemic oestrogen therapy on FI in postmenopausal women. METHODS: A systematic review of all studies in postmenopausal women was performed to establish how oestrogen therapy affects FI. Eight articles were deemed eligible for inclusion following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Their quality was assessed using the Cochrane risk-of-bias tool (RoB-2) and Newcastle-Ottawa quality assessment scale. RESULTS: One randomised controlled trial (RCT), two cohort studies, one observational and four cross-sectional studies were identified. The RCT showed an improvement in FI with anal oestrogen (p = 0.002), but this improvement was also observed in the placebo arm (p = 0.013) and no difference was seen between these groups. A prospective observational study demonstrated significant improvement with an oestrogen patch (p = 0.004), but had no control group. Conversely, a large prospective cohort study demonstrated an increased hazard ratio of FI with current (1.32; 95% CI, 1.20-1.45) and previous oestrogen use (1.26; 95% CI, 1.18-1.34) compared with non-users. CONCLUSION: All studies had a high risk of bias and had conflicting views on the effects of oestrogen on FI in postmenopausal women. This review has identified the need for further research in this area by highlighting the paucity of good research for evidence-based practice. We believe that a further RCT of local oestrogen is mandated to draw a valid conclusion.

The effect of body mass index on retropubic midurethral slings.

BACKGROUND: Analyzing surgical databases uses "real-life" outcomes rather than highly selected cases from randomized controlled trials. Retropubic midurethral slings are a highly effective surgical treatment for stress urinary incontinence; however, if modifiable patient characteristics alter outcomes, thereby rendering treatments less effective, patients should be informed and given the opportunity to change that characteristic. OBJECTIVE: The aim of this study was to evaluate the effect of body mass index on patient-reported outcome measures by analyzing midurethral slings from the British Society of Urogynaecology database. MATERIALS AND METHODS: The British Society of Urogynaecology approved analysis of 11,859 anonymized midurethral slings from 2007 to 2016. The primary outcome of this retrospective cohort study was to assess how body mass index affects patient-reported outcome measures. Outcomes were assessed at 6 weeks, 3 months, 6 months, or 12 months after surgery, depending on local arrangements. Outcomes were compared by body mass index groups using χ2 tests. RESULTS: As BMI increased, Patient Global Impression of Improvement (PGI-I) scores declined. Women with a normal body mass index (18 to <25) reported feeling better in 91.6% of cases compared to lower rates in BMI groups >30 (87.7-72%) (P < .001). Patient-reported outcome measures for stress urinary incontinence inversely correlated with body mass index, with 97% of women with normal body mass index stating that they were cured/improved compared to women in higher body mass index groups (84-94%) reporting lower rates (P < .005). Patient-reported outcome measures for overactive bladder show that as body mass index increases, patients reported higher rates of worsening symptoms (P < .05). There were higher rates of perforation at the low and high extremes of body mass index. CONCLUSION: Our results suggest increased body mass index is associated with poorer outcomes after midurethral sling surgery, and that patients should be given the opportunity to change their body mass index. These data could help to develop a model to predict personalized success and complication rates, which may improve shared decision making and give an impetus to modify characteristics to improve outcomes.

What can we learn from large data sets? An analysis of 19,000 retropubic tapes.

INTRODUCTION AND HYPOTHESIS: Retropubic tapes are successful for treating stress urinary incontinence (SUI), but there is controversy around risk profiles. The British Society of Urogynaecology (BSUG) database allows analysis of surgery for patient safety, surveillance and benchmarking. Objectives of this study were to establish success and complication rates in routine practice, determine complication rates for trainees and consultants, explore reasons for outliers and assess perforation as a surrogacy of quality. METHODS: Approval was obtained from BSUG to use data on retropubic tapes. Data was anonymised, and patients gave prior consent. Analysis was done using the χ2 test, and a funnel plot of bladder perforation rate was calculated. RESULTS: There were 18,763 procedures recorded: 14,156 were performed by consultants, 64 by associate specialists (64), 1140 by subspecialty trainees, 2549 by registrars, 201 staff grades and 377 other. We found a 3.5 % bladder perforation rate, which was statistically higher for trainees than consultants (p < 0.05). The rate of other "standard" complications were low: 95.8 % of patients felt better on the Patient Global Impression of Improvement of Incontinence (PGI) scale. There was a significant difference (p < 0.05) in PGI and SUI outcome between patients who did and did not experience perforation. CONCLUSIONS: Success rates with retropubic tapes are high, with low complication rates. Bladder perforation in "real", not "trial" data was 3.5 %, which is lower than reported by the Cochrane review (4.5 %). Trainees have a higher perforation rate (p < 0.05) because of learning curves. Outliers are easily identified, and reasons for this should be explored, including proportion of trainees doing the surgery. This analysis confirms that bladder perforation is a valid surrogate for quality with a small but measurable difference. We have a responsibility to analyse data to improve patient care and encourage colleagues to support the International Urogynaecology Association (IUGA) database initiative.

Predicting urinary incontinence in women in later life: A systematic review.

Urinary incontinence (UI) affects 10-40% of the population and treatment costs in the UK are estimated to be £233 million per annum. A systematic review of online medical databases between July 1974 and 2016 was conducted to identify studies that had investigated risk and prediction strategies of UI in later life. Eighteen prospective longitudinal studies fulfilled the search criteria. These were analysed systematically (as per the PRISMA checklist) and bias risk through study design was minimised where possible upon data analysis. One paper proposed a predictive assessment tool called the 'continence index'. It was derived following secondary analysis of a cohort study and its predictive threshold had suboptimal sensitivity (79%) and specificity (65%) rates. Seventeen studies identified multiple strong risk factors for UI but despite a large selection of papers on the topic, no robust risk assessment tool prospectively identified patients at risk of UI in later life. Thus more research in this field is required. Clinicians should be aware particularly of modifiable UI risk factors to help reduce the clinical burden of UI in the long term.

An observational study of women with müllerian agenesis and their need for vaginal dilator therapy.

OBJECTIVE: To assess vaginal development, sexual activity, and the efficacy of vaginal dilator therapy in women with vaginal agenesis (Mayer-Rokitansky-Kuster-Hauser syndrome). DESIGN: Retrospective case review. SETTING: Tertiary referral university teaching hospital clinic for disorders of sexual development and differentiation (DSDD). PATIENT(S): Eighty cases of Rokitansky syndrome. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Sexual activity and vaginal dimensions. RESULT(S): The retrospective case review examined vaginal dimensions and sexual activity at presentation with further evaluation at completion of vaginal dilator therapy. Eleven of 80 patients had undergone surgery in the past; six of these 80 women had received dilator training elsewhere, and four were sexually active. Sixty-three of 80 patients had not undergone any previous treatment. Seventeen were having satisfactory sexual intercourse, 16 were having unsatisfactory sexual intercourse, and 26 had never been sexually active; for four women, no information had been recorded. A total of 32 patients underwent vaginal dilator treatment, and 25 completed the therapy. Their vaginal length increased from 3.2 cm (range: 0 to 7 cm) to 6.1 cm (range: 3 to 9 cm). CONCLUSION(S): Diagnosis and management of müllerian agenesis may be achieved without the need for surgery in the majority of cases. Dilator treatment for vaginal agenesis should be offered as first-line treatment, coordinated by a specialist nurse with input from a psychologist.