What Are the Short-term Benefits and Potential Harms of Therapeutic Modalities for the Management of Overactive Bladder Syndrome in Women? A Review of Evidence Under the Auspices of the European Association of Urology, Female Non-neurogenic Lower Urinary Tract Symptoms Guidelines Panel.

CONTEXT: Overactive bladder syndrome (OAB) is highly prevalent among women and has a negative impact on their quality of life. The current available treatments for OAB symptoms include conservative, pharmacological, or surgical modalities. OBJECTIVE: To provide an updated contemporary evidence document regarding OAB treatment options and determine the short-term effectiveness, safety, and potential harms of the available treatment modalities for women with OAB syndrome. EVIDENCE ACQUISITION: The Medline, Embase, and Cochrane controlled trial databases and clinicaltrial.gov were searched for all relevant publications up to May 2022. The risk of bias assessment followed the recommended tool in the Cochrane Handbook for Systematic Reviews of Interventions, and quality of evidence was assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis was performed where appropriate. EVIDENCE SYNTHESIS: Antimuscarinics and beta-3 agonists were significantly more effective than placebo across most outcomes, with beta-3 agonists being more effective at reducing nocturia episodes and antimuscarinics causing significantly higher adverse events. Onabotulinumtoxin-A (Onabot-A) was more effective than placebo across most outcomes, but with significantly higher rates of acute urinary retention/clean intermittent self-catheterisation (six to eight times) and urinary tract infections (UTIs; two to three times). Onabot-A was also significantly better than antimuscarinics in the cure of urgency urinary incontinence (UUI) but not in the reduction of mean UUI episodes. Success rates of sacral nerve stimulation (SNS) were significantly higher than those of antimuscarinics (61% vs 42%, p = 0.02), with similar rates of adverse events. SNS and Onabot-A were not significantly different in efficacy outcomes. Satisfaction rates were higher with Onabot-A, but with a higher rate of recurrent UTIs (24% vs 10%). SNS was associated with 9% removal rate and 3% revision rate. CONCLUSIONS: Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include Onabot-A bladder injections or SNS. The choice of therapies should be guided by individual patient factors. PATIENT SUMMARY: Overactive bladder is a manageable condition. All patients should be informed and advised on conservative treatment measures in the first instance. The first-line treatment options for its management include antimuscarinics or beta-3 agonists medication, and posterior tibial nerve stimulation procedures. The second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation procedure. The therapy should be chosen based on individual patient factors.

Effectiveness and costs of a new framework for selecting absorbent urinary incontinence products compared with current practice: a cohort study.

OBJECTIVES: To improve continence care in the Netherlands, a new framework has been developed in which a shift has been made from incontinence severity as the sole criterion for selecting incontinence products to a focus on patient need for daily life activities. The impact of the framework on daily care has not been assessed. We aimed to compare treatment effectiveness and costs between participants who did and did not undergo re-evaluation according to the new framework. DESIGN: Cohort study SETTING: Twelve pharmacies in the Netherlands PARTICIPANTS: Existing users of absorbent incontinence materials for urinary incontinence. INTERVENTIONS: Participants were offered the option to have their incontinence products re-evaluated within the new framework at their pharmacy. PRIMARY AND SECONDARY OUTCOME MEASURES: Effectiveness and cost outcomes were assessed at 3 and 6 months through questionnaires. These questionnaires included the International Consultation on Incontinence Questionnaire (ICIQ) Lower Urinary Tract Symptoms Quality of Life Module, ICIQ Urinary Incontinence Short Form, ICIQ Absorbent Pads, questions about satisfaction and the iPCQ and iMCQ. RESULTS: 303 users consented and 279 completed the baseline questionnaire. Of these participants, 72 agreed to a re-evaluation of their incontinence materials. There was a small improvement at 3 months in the re-evaluation group compared with the other group on most outcomes. However, these improvements were not clinically relevant. Moreover, these differences did not change much from 3 to 6 months. Small differences were also observed in the changes in costs, but with very wide CIs on both sides of zero (€99.38; 95% CI -633.48 to 832.23). CONCLUSIONS: The current study showed no clinically relevant effect of a newly implemented framework for selecting incontinence materials in pharmacies when compared with an existing method. Given that the study also showed no differences in effectiveness and costs, introducing the new framework in pharmacies may not lead to better incontinence care.

Association of Supply Source with Continence Product and Care Satisfaction in Patients with Urinary Incontinence.

Purpose: We aimed to examine how supply source affects satisfaction with continence products and care among individuals with urinary incontinence (UI). Supply source was compared among pharmacies, national suppliers, and shops. The secondary aim was to compare participant characteristics between the three groups. Patients and Methods: A survey questionnaire was distributed via social media between April and June 2020. This included the international consultation on incontinence questionnaire (ICIQ) UI short form (ICIQ-UI-SF), the ICIQ-PadPROM, and the ICIQ-LUTSqol, together with questions about respondent characteristics and satisfaction with continence products. Results: Of the 1045 respondents, 706 fully completed and 339 partially completed the survey. Among these, 322 (45.6%), 199 (28.1%), and 185 (26.2%) made purchases from shops, national suppliers, and pharmacies, respectively. The mean ICIQ-UI-SF sum scores were comparable for the pharmacy (13.3 ± 3.7) and national supplier (13.8 ± 3.5) groups, but were significantly lower for the shop group (12.0 ± 3.3). Mean sum scores for satisfaction with continence products and satisfaction with continence care were also significantly lower in the shop group (7.9 ± 2.6 and 6.4 ± 2.7, respectively) compared with the pharmacy (9.1 ± 2.7 and 7.9 ± 2.6, respectively) and national supplier (9.3 ± 2.6 and 8.1 ± 3.0, respectively) groups. There were no statistically significant differences in the ICIQ-PadPROM and ICIQ-LUTSqol scores. Respondents' characteristics were similar, apart from the significantly lower number of males in the shop group. Conclusion: Satisfaction with continence products and continence care is lower for people with UI who purchase materials from a shop than from a pharmacy or national supplier.

European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence.

CONTEXT: Female lower urinary tract symptoms (LUTS) are a common presentation in urological practice. Thus far, only a limited number of female LUTS conditions have been included in the European Association of Urology (EAU) guidelines compendium. The new non-neurogenic female LUTS guideline expands the remit to include these symptoms and conditions. OBJECTIVE: To summarise the diagnostic section of the non-neurogenic female LUTS guideline and the management of female overactive bladder (OAB), stress urinary incontinence (SUI), and mixed urinary incontinence (MUI). EVIDENCE ACQUISITION: New literature searches were carried out in September 2021 and evidence synthesis was conducted using the modified GRADE criteria as outlined for all EAU guidelines. A new systematic review (SR) on OAB was carried out by the panel for the purposes of this guideline. EVIDENCE SYNTHESIS: The important considerations for informing guideline recommendations are presented, along with a summary of all the guideline recommendations. CONCLUSIONS: Non-neurogenic female LUTS are an important cause of urological dysfunction. Initial evaluation, diagnosis, and management should be carried out in a structured and logical fashion based on the best available evidence. This guideline serves to present this evidence to health care providers in an easily accessible and digestible format. PATIENT SUMMARY: This report summarises the main recommendations from the European Association of Urology guideline on symptoms and diseases of the female lower urinary tract (bladder and urethra) not associated with neurological disease. We cover recommendations related to diagnosis of these conditions, as well as the treatment of overactive bladder, stress urinary incontinence, and mixed urinary incontinence.

European Association of Urology Guidelines on the Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 2: Underactive Bladder, Bladder Outlet Obstruction, and Nocturia.

CONTEXT: Female lower urinary tract symptoms (LUTS) are a common presentation in urological practice. Thus far, only a limited number of female LUTS conditions have been included in the European Association of Urology (EAU) guidelines compendium. The new non-neurogenic female LUTS guidelines expand the remit to include these symptoms and conditions. OBJECTIVE: To summarise the management of underactive bladder (UAB), bladder outlet obstruction (BOO), and nocturia in females. EVIDENCE ACQUISITION: The literature search was updated in September 2021 and evidence synthesis was conducted using modified GRADE approach as outlined for all EAU guidelines. A new systematic review on BOO was carried out by the panel for purposes of this guideline. EVIDENCE SYNTHESIS: The important considerations for informing guideline recommendations are presented, along with a summary of all the guideline recommendations. CONCLUSIONS: Non-neurogenic female LUTS are an important presentation of urological dysfunction. Initial evaluation, diagnosis, and management should be carried out in a structured and logical fashion on the basis of the best available evidence. This guideline serves to present this evidence to practising urologists and other health care providers in an easily accessible and digestible format. PATIENT SUMMARY: This report summarises the main recommendations from the European Association of Urology guideline on symptoms and diseases of the female lower urinary tract (bladder and urethra) not associated with neurological disease. We cover recommendations related to the treatment of underactive bladder, obstruction of the bladder outlet, and nighttime urination.

The effect of EMG biofeedback assisted pelvic floor muscle therapy on symptoms of the overactive bladder syndrome in women: A randomized controlled trial.

AIMS: The overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence. Biofeedback-assisted pelvic muscle therapy (BAPFMT) is a first-line treatment option for OAB. The aims of this study were to determine the efficacy and effectiveness of BAPFMT on symptoms of OAB after 9 weeks of treatment and to detect changes EMG activity of individual pelvic floor muscles (PFM) with the MAPLe. METHODS: Patients were randomly divided into an intervention group that received BAPFMT with the MAPLe or into a control group which received only toilet behavior and lifestyle instructions. The Pelvic Floor Inventories (PeLFIs), the King's Health Questionnaire (KHQ), a voiding dairy, a 24 h pad-test, and vaginal EMG registration of the pelvic floor with the MAPLe were used at inclusion and after 9 weeks follow-up to determine the effect of BAPFMT on complaints of OAB and Quality of Life (QoL). RESULTS: Fifty-eight patients were included. The PeLFIs, KHQ, voiding dairy, and 24 h pad-test showed significant improvements in the intervention group compared to the control group in complaints of OAB and QoL. EMG activity showed significant improvements for specific individual muscles at the different sides and depths for rest, maximal voluntary contraction, and endurance. CONCLUSIONS: EMG BAPFMT is effective in the OAB syndrome in women. It significantly reduces symptoms and complaints of OAB and increases QoL for patients. It shows that EMG changes in individual PFM, measured with the MAPLe, are relevant and related to symptom reduction.

Effect of preoperative pelvic floor muscle therapy with biofeedback versus standard care on stress urinary incontinence and quality of life in men undergoing laparoscopic radical prostatectomy: a randomised control trial.

AIMS: Laparoscopic radical prostatectomy (LARP) may cause stress urinary incontinence (SUI). This study reports the effects of preoperative pelvic floor muscle therapy (PFMT) on SUI and quality of life (QoL) in men undergoing LARP. MATERIALS AND METHODS: In this single-center randomized controlled trial, 122 patients undergoing LARP were assigned to an intervention group of PFMT with biofeedback once a week preoperatively, with 4 weeks' follow-up or to a control group receiving standard care. Randomization and allocation to the trial group were carried out by a central computer system. The primary analysis was based on 121 (n = 65; n = 56), comparing SUI rates and QoL in the two groups in a 1-year follow-up. Validated questionnaires, the Pelvic Floor Inventories (PeLFls), the King's Health Questionnaire (KHQ), the International Prostate Symptom Score (IPSS), a bladder diary, a 24-hr pad test and pelvic floor examination were used. Continence was defined as no leakage at all. All analyses were performed according to intention-to-treat. RESULTS: One hundred twenty-two patients were randomized, 19 patients were excluded from analysis because of early drop-out. There were no significant differences between both groups in the incidence of SUI and QoL based on the KHQ, IPSS, and pad tests (P ≥ 0.05). In all patients continence was achieved in 77.2% at 1 year postoperatively. CONCLUSIONS: Preoperative PFMT does not appear to be effective in the prevention of SUI and QoL following LARP.

Reliability and differentiation of pelvic floor muscle electromyography measurements in healthy volunteers using a new device: the Multiple Array Probe Leiden (MAPLe).

AIMS: A new multiple electrode probe, the Multiple Array Probe Leiden (MAPLe), has been developed for biofeedback registration of the individual pelvic floor musculature (PFM). The aim was to determine the reliability and differentiation of electromyography (EMG) signals measured with the MAPLe in healthy volunteers. METHODS: Two hundred twenty nine healthy volunteers not seeking treatment or using medication for symptoms of prolapse, lower urinary tract, bowel, pain, and/or sexual function related to pelvic floor dysfunction were qualified to participate. Subjects were asked to perform five tasks: rest, maximum voluntary contractions, endurance, cough, and valsalva. Mean EMG values per electrode were registered. Test-retest reliability was assessed using linear mixed model with random subject effects. One-way ANOVA tests were performed to detect differences between groups. RESULTS: Magnetic resonance imaging (MRI) showed that each of the electrodes could be related nearest to the individual muscles. For test-retest, the intraclass correlation ranged from 0.53 to 0.91. The MAPLe showed significant differences in average EMG values between men and women, and between nulliparous and parous, pre- and prostmenpausal women. Significant differences were seen between the left and right sides of the pelvic floor. In addition, the activity nearest to the individual pelvic floor muscles (external anal sphincter (EAS), puborectalis muscle, bulbospongiosus, ischiocavernosus and the pubococcygeus muscle) could be determined. CONCLUSIONS: The MAPLe is a reliable instrument measuring the EMG signals of the different sides and levels nearest to the pelvic floor musculature and is capable to differentiate between men and women, nulliparous, parous, pre- and postmenopausal. The findings of this study have implications for the diagnosis and treatment of pelvic floor dysfunction in the future.