A prospective, randomized trial comparing intravesical dimethyl sulfoxide (DMSO) to bupivacaine, triamcinolone, and heparin (BTH), for newly diagnosed interstitial cystitis/painful bladder syndrome (IC/PBS).

INTRODUCTION AND HYPOTHESIS: The primary aim of this study was to compare the effect of bladder instillations using dimethyl sulfoxide (DMSO) with triamcinolone versus bupivacaine, triamcinolone, and heparin (BTH) in women with newly diagnosed interstitial cystitis/painful bladder syndrome. The primary outcome was improvement in symptoms measured using the O'Leary-Sant Interstitial Cystitis Symptoms Index (ICSI) score. Secondary comparisons included changes in urinary frequency, nocturia, and bladder capacity. MATERIALS AND METHODS: This was a prospective, randomized study. Patients with a recent diagnosis of interstitial cystitis/painful bladder syndrome (IC/PBS) were randomized 1:1 to treatment with either 6 weekly bladder instillations of DMSO with triamcinolone or BTH. During follow-up visits, patients completed the ICSI questionnaire, and bladder capacity was determined through the retrograde filling of the bladder. The χ2 test or Student's t test were used for data analysis. RESULTS: A total of 83 patients were randomized, and final analysis included 70 participants who completed the 6 weekly instillations (42 DMSO, 28 BTH). The groups were similar in baseline demographics and clinical characteristics, except for cystometric maximum capacity (DMSO 338.62± 139.44 mL, BTH 447.43 ± 180.38 mL, p = 0.01). In the DMSO group, 63% of patients had a greater than 29.5% reduction in total ICSI score versus 43% in the BTH group (p = 0.15). Nocturia and pain were significantly reduced in the DMSO group. There was a significant increase from baseline in bladder capacity for both groups. CONCLUSION: In women with newly diagnosed IC/PBS, bladder instillations with DMSO and triamcinolone provide greater improvement in pain and nocturia compared to BTH.

The female urethra: urethral function throughout a woman's lifetime.

INTRODUCTION AND HYPOTHESIS: The objective of this narrative review is to describe changes in urethral function that occur during a woman's lifetime. Evaluation of urethral function includes measurements of urethral closure pressure, at rest and during stress, leak point pressure, and the detailed study of anatomical and histological changes of the urethral sphincteric mechanism. METHODS: A literature search in MEDLINE, PubMed, and relevant journals from 1960 until 2020 was performed for articles dealing with urethral function and the impact of aging, pregnancy, and childbirth, female hormones, and menopausal transition on the urethral sphincteric mechanism. Longitudinal and cross-sectional epidemiological surveys, studies on histological changes in urethral anatomy during aging, and urodynamic data obtained at different points in a woman's lifetime, during pregnancy, after childbirth, as well as the effects of female hormones on urethral sphincter function are reviewed. Relevant studies presenting objective data are analyzed and briefly summarized. RESULTS AND CONCLUSIONS: The findings lead one to conclude that a constitutional or genetic predisposition, aging, and senescence are the most prominent etiological factors in the development of urinary incontinence and other pelvic floor disorders. Vaginal childbirth dilates and may damage the compressed pelvic supportive tissues and is invariably associated with a decline in urethral sphincter function. Pregnancy, hormonal alterations, menopausal transition, weight gain, and obesity are at best of secondary influence on the pathology of lower urinary tract dysfunction. The decline of circulating estrogens during menopausal transition may play a role in the transition of fibroblasts to cellular senescence.

Feasibility and Efficacy of Intensive Dialectical Behavior Therapy Skills Training in An Outpatient Setting for A Group of Patients with Extensive Care Needs - A Transdiagnostic Approach.

PURPOSE: Dialectical behavior therapy (DBT) is a treatment originally developed för chronically suicidal adults. It is common to adapt it by using one specific component, the DBT skills training (DBT-ST) and apply it in a group therapy setting for a variety of mental disorders. The primary aim of the study was to explore whether patients with extended care needs would report improved mental health after participating in an intensive form of DBT-ST. The secondary aim was to explore whether the use of psychiatric inpatient care for the group would decrease. METHODS: Thirty-seven participants completed the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), and visual analogue scale (VAS) at three time points: pre-intervention, post-intervention and at 6-month follow-up after intensive DBT-ST. RESULTS: One-way ANOVA showed a significant effect for time on the CORE-OM: F (2,35) = 7.93, p = .001, η2 = 0.312 (large effect size). Post hoc tests indicated a significant difference between pre-intervention and post-intervention (p = .001) and between pre-intervention and follow-up (p = .01). A Friedman test indicated a statistically significant difference in the VAS scale scores across the three time points, with p-values between 0.00 and 0.05. There was no difference in psychiatric healthcare consumption. CONCLUSION: These study results confirm to some extent the feasibility and effectiveness of the intensive DBT-ST in a transdiagnostic clinical setting. The participants had a positive outcome from the skills training program, but psychiatric healthcare consumption did not decrease.

Methenamine hippurate compared with trimethoprim for the prevention of recurrent urinary tract infections: a randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: The objective was to find an alternative treatment to a low-dose antibiotic for the prevention of recurrent urinary tract infections (UTI) and to evaluate the difference in rates of reinfection within 1 year when treated with methenamine hippurate for prophylaxis compared with trimethoprim. METHODS: We present a non-blinded randomized trial comparing methenamine hippurate with trimethoprim for the prevention of recurrent UTI at 12 months after starting treatment. Women over 18 who had at least two culture-positive UTI in the prior 6 months or three in the prior year were included. Ninety-two patients met enrollment criteria and were randomized to receive daily prophylaxis with methenamine hippurate or trimethoprim for a minimum of 6 months. Both intent-to-treat and per-protocol analyses if patients received the alternative drug after randomization were analyzed using Student's t test, Mann-Whitney U test, Kaplan-Meier curves, log-rank test, and a logistic and multivariate regression model. The primary outcome of this study was culture-proven UTI recurrence by 12 months after initiating prophylaxis. RESULTS: In the intent-to-treat analysis, we found no difference between groups in recurrent UTI, with a 65% (28 out of 43) recurrence in the trimethoprim group versus 65% (28 out of 43) in the methenamine hippurate group (p = 1.00). In the per-protocol analysis, 65% (26 out of 40) versus 65% (30 out of 46) of patients had UTI recurrences in the trimethoprim group versus the methenamine hippurate group (p = 0.98). CONCLUSIONS: Methenamine hippurate may be an alternative for the prevention of recurrent UTI, with similar rates of recurrence and adverse effects to trimethoprim.

Can patients independently identify their urinary incontinence symptoms?

INTRODUCTION AND HYPOTHESIS: The objective of our study is to compare patient self-reported urinary incontinence symptoms based on the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) question number 6 (When does urine leak?) with physician-assessed interpretation of the patient's urinary incontinence symptoms. METHODS: This trial is a cross-sectional study of patients who presented to a tertiary urogynecology center with symptoms of urinary incontinence between January 2014 and August 2016. We compared patient-reported symptoms on the ICIQ-SF with physician interpretation of urinary complaints during their initial visit. The urinary incontinence symptoms included stress urinary incontinence (SUI), urgency urinary incontinence (UUI), insensible urine loss, nocturnal enuresis, and post-micturition dribbling. RESULTS: A total of 432 patients with a mean age of 61 were included in this evaluation. The most common urinary incontinence symptoms according to the physician were UUI (n = 357, 83%), followed by SUI (n = 308, 71%). Of the patients who were diagnosed by a physician with the symptom of UUI, only 61% self-identified as having this symptom based on the ICIQ-SF, and for SUI, only 66% self-identified as having SUI symptoms based on the ICIQ-SF. Overall UUI (κ = 0.30) appears to have poor agreement, as does nocturnal enuresis (κ = 0.39), when compared with physician historical assessment. CONCLUSION: There is a discrepancy between patient-reported urinary incontinence symptoms on the ICIQ-SF and physician-assessed symptoms. Symptomatology entered into electronic medical records by patients is often inaccurate. Physician validation is essential in understanding the underlying the precise symptomatology.

Psychiatrists' Experience of Vocational Rehabilitation for Patients with Mental Illness.

The aim of this study was to explore psychiatrists' experience of vocational rehabilitation for patients with mental illness. The study employed a qualitative design to explore psychiatrists' experience of vocational rehabilitation. Ten psychiatrists, five women and five men, 33-62 years of age (median 40), were interviewed. All of them worked with patients at Sahlgrenska University Hospital. The interviews were analyzed using inductive thematic analysis. All participants considered vocational rehabilitation to be of great importance for patients' well-being and health. The results were characterized by two opposite experiences: frustration and agency, these were the two main themes in the analysis. All narratives embraced both experiences, but some reflected more frustration and others more agency. In order for the psychiatrist to master the assignment, there is a need for further training and supervision. The psychiatrist's role, as well as other professional roles within the team, requires clarification, and the support from rehabilitation coordinators and occupational therapists should be enhanced. There is a need for improved cooperation with external actors.

Cognitive changes in women starting anticholinergic medications for overactive bladder: a prospective study.

INTRODUCTION AND HYPOTHESIS: To assess cognitive changes in women 12 months after starting anticholinergic medications for overactive bladder syndrome (OAB). METHODS: We present a prospective cohort study assessing changes in cognition in women seen in a referral urogynecology practice. We compared women who started anticholinergic OAB medications with women not on anticholinergic OAB medications. The primary outcome was change over time on the Montreal Cognitive Assessment (MOCA) screening score. At enrollment, women completed a baseline MOCA screening, a Geriatric Depression Screen (GDS), and an assessment of medications to create an anticholinergic burden score (ACB). At 3, 6, 9, and 12 months after enrollment women were administered the MOCA, GDS, and a review of their medications and medical problems. Statistical analysis was performed using a linear mixed effects model taking into account correlated error terms given multiple MOCA assessments at various time points per patient. RESULTS: A total of 106 women were enrolled, 60 in the OAB medication group and 46 in the control (non-OAB medication) group. The mean age was 77 years, 93% of women were Caucasian, and 98% completed high school, with no difference between groups. Over time there was no difference in change of MOCA score between the OAB and control groups when controlling for age, GDS score, and ACB score (p = 0.78). This association did not change when women with a neurological diagnosis were excluded (n = 6). On average MOCA scores for the OAB group increased by 0.76 over 12 months and the control group increased 0.39, with no difference between the groups (p = 0.53). CONCLUSIONS: We found no changes in MOCA scores between OAB medication and control groups after controlling for age, depression, and polypharmacy after 12 months of follow-up.

The reliability of the health related quality of life questionnaire PedsQL 3.0 cancer module in a sample of Swedish children.

BACKGROUND: The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument, designed to integrate generic and disease specific measures, and includes both self- and proxy-reports. The aim of the study was to assess the reliability and limited validity of the Swedish version of the disease specific Pediatric Quality of Life Inventory 3.0 Cancer Module Scales (PedsQL 3.0), in a sample of Swedish children diagnosed with cancer. METHOD: A total of 94 families at The Queen Silvia Children's Hospital, Sahlgrenska University participated in the study. The Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL 4.0) and the PedsQL 3.0 were administered to 63 children (aged 5-18 years) with cancer and to 94 parents of children with cancer aged 2-18 years. RESULTS: The internal consistency of the PedsQL 3.0, reached or exceeded Cronbach's alpha values of 0.70 for both -self- and proxy-reports. The PedsQL 4.0 and PedsQL 3.0 were highly correlated (r = 0.94 for proxy-reports and r = 0.91 for self-reports), indicating convergent validity. CONCLUSION: PedsQL 3.0 Cancer Module Scales can be used as a valuable tool for measuring cancer-specific HRQOL in child populations, both in research and in clinical practice.

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence.

PURPOSE: We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence. MATERIALS AND METHODS: This prospective, single arm, open label study included 46 participants with refractory urgency urinary incontinence. It was performed at multiple sites in the United States and New Zealand. The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality of life instruments were collected 3 and 6 months after activation and compared to baseline values. RESULTS: The mean ± SD age of participants was 63.4 ± 11.5 years and 45 (98%) were female. Episodes of urgency urinary incontinence were reduced a relative median of 71% after 3 months of treatment (4.2 vs 1.7 daily episodes at 3 months, p = 0.001). A 50% or greater decrease in reported episodes of urgency urinary incontinence was observed in 32 of 46 participants (69.6%) at 3 months with more than 20% dry at 3 and 6 months. I-QOL (Incontinence Quality of Life) scores improved an average of 25.9 points and 33 of 46 patients (72%) indicated improvement in symptoms. A single serious adverse event secondary to wound care resolved with intravenous antibiotics. CONCLUSIONS: The implantable neuromodulation device was a safe and effective treatment of urgency urinary incontinence associated with overactive bladder syndrome with a significant reduction or resolution of symptoms and no significant safety concerns.

Surgery for urinary incontinence in women: Report from the 6th international consultation on incontinence.

Urinary incontinence is a prevalent condition worldwide and causes a tremendous impact on a woman's quality of life. While conservative and non-surgical therapies are options for treatment, surgery for stress urinary incontinence (SUI) is common. Options include colposuspension, slings (pubovaginal and midurethral), and periurethral bulking. While evidence supports each of these options in the treatment of SUI, each is associated with various rates of success and unique adverse event profiles. Urgency urinary incontinence (UUI) is initially treated with behavioral modification and pharmacologic means, with surgery reserved for those with refractory symptoms or significant complications from medication use. At present, intravesical onabotulinumtoxinA injections, percutaneous tibial nerve stimulation, and sacral neurostimulation are all viable options for refractory UUI/overactive bladder. As with surgical interventions for SUI, each of these is, likewise, associated with unique outcomes and adverse event profiles. Herein, we summarize the findings and conclusions from the 6th International Consultation on Incontinence (ICI) regarding surgical treatment of urinary incontinence in women.

Predictors of successful percutaneous tibial nerve stimulation (PTNS) in the treatment of overactive bladder syndrome.

INTRODUCTION AND HYPOTHESIS: Multiple publications have demonstrated the efficacy of percutaneous tibial nerve stimulation (PTNS) for overactive bladder syndrome (OAB). However, patient characteristics associated with successful treatment have not been well established. The aim of this study was to identify prognostic factors for successful PTNS treatment. METHODS: This was a retrospective chart review of women who underwent PTNS therapy for OAB between January 2011-Decemeber 2017. Treatment success was defined by subjective improvement according to patient self-report and objective bladder diary parameters including the intervoiding interval, nocturia episodes and urgency urinary incontinence (UUI) episodes per day, before and after PTNS treatment. Baseline symptoms were dichotomized for each symptom based on severity. RESULTS: One hundred sixty-two women with a mean age of 72.7 ± 11.3 years and BMI of 28.5 ± 7.1 were included in the study. There was a statistically significant improvement in all three OAB symptoms after treatment. Multivariable analysis revealed that a history of depression and anxiety was associated with subjective improvement, whereas decreased subjective improvement was associated with a history of hypertension, prior intravesical onabotulinnumtoxinA injection and sacral neuromodulation. While dichotomizing subjects into two groups defined by < 50% versus ≥ 50% improvement, depression/anxiety, urodynamic volume at first sensation to void and more severe baseline urgency urinary incontinence severity were all significant predictors of subjective improvement. CONCLUSIONS: Among women treated with PTNS for refractory OAB, a history of depression/anxiety and severe baseline urgency urinary incontinence were positive predictors of a successful PTNS outcome.

Subjective and objective responses to PTNS and predictors for success: a retrospective cohort study of percutaneous tibial nerve stimulation for overactive bladder.

INTRODUCTION AND HYPOTHESIS: We investigated the objective improvements in overactive bladder (OAB) symptoms in patients undergoing percutaneous tibial nerve stimulation (PTNS) and predictive factors of patient satisfaction. METHODS: In this single-center retrospective cohort study at a tertiary urogynecology center, we identified all female patients who underwent PTNS therapy from 1 October 2007 - 1 January 2016 and followed them from their initial visit through medication therapy and PTNS treatments. Patients who tried at least one medication prior to starting PTNS therapy and completed at least one PTNS visit were included. Baseline demographic data, urinary data, and details of medication and PTNS therapy sessions were collected from records through chart review. Paired or two-sample t-tests were used to compare changes over time or groups. Bivariate and multivariable logistic regression were performed. RESULTS: Two hundred thirteen patients underwent PTNS therapy and 183 patients met the criteria. Overall patients were able to decrease voiding frequency by 1 h, decrease nocturia episodes by 0.8, and decrease urge incontinence episodes with PTNS therapy by ten episodes per week (p = 0.02). Patients who continued OAB medications did not have additional improvements compared with patients who did not continue OAB medications during PTNS. Overall, 25.4% (43/169) patients reported ≥ 75% improvement during PTNS therapy, and 61.5% (104/169) reported ≥ 50% improvement. When evaluating predictive factors of ≥ 50% overall improvement, the number of PTNS sessions increased odds of subjective success (OR = 1.8, p = 0.004). Other factors were not significant predictors of subjective PTNS success. CONCLUSIONS: PTNS can provide both objective and subjective improvements for patients who do not respond to OAB medication therapy.

A review of the impact of pregnancy and childbirth on pelvic floor function as assessed by objective measurement techniques.

The objective of this narrative review is to study the impact of pregnancy and childbirth on pelvic floor function as assessed by objective measurement techniques with quantitative data carried out during pregnancy and after childbirth. A literature search in MEDLINE and relevant and up-to-date journals from 1960 until April 2017 was performed for articles dealing with the impact of pregnancy and childbirth on pelvic floor function as assessed by objective measurement methods. Only studies describing objective measurement techniques. i.e., urodynamics, ultrasound (US), magnetic resonance imaging (MRI), Pelvic Organ Prolapse Quantification (POP-Q) system, and neurophysiologic tests carried out throughout pregnancy and after childbirth are included. Relevant studies presenting objective quantitative data are analyzed and briefly summarized. The number of studies meeting selection criteria was relatively few. Pregnancy, especially first pregnancy, is associated bladder neck lowering, increased bladder neck mobility, pelvic organ descent, decreased levator ani strength, and decreased urethral resistance. These changes are accentuated after vaginal delivery. Data on the impact of obstetrical and neonatal variables are transient and seem of less importance. Cesarean delivery is not completely protective. In most women, pelvic floor muscle function recovers in the year after delivery. Objective measurement techniques during pregnancy may allow identification of women susceptible to pelvic floor dysfunction later in life and offer the opportunity for counseling and preventive treatment strategies.

Counseling in urogynecology: A difficult task, or simply good surgeon-patient communication?

Surgical treatments for pelvic organ prolapse (POP) and urinary incontinence (UI) have greatly changed in recent years. Prompted by increases in reports of adverse outcomes in relation to such treatments, several scientific societies and researchers have emphasized providing patients with thorough counseling before treating them. Patient-centered communication has become the gold standard for excellence in clinical care. This challenges clinicians to be cognizant of their patients' perspectives, motivations, expectations, fears, concerns, and social contexts to enable them to reach a shared understanding with patients. Considering this, urogynecology counseling represents a crucial process through which women can gain a clear understanding of their clinical condition and the risks and benefits of potential treatment options. However, many urogynecologists believe that proposing a treatment and providing only enough detail to secure informed consent constitutes counseling. This article is intended to describe good counseling for women undergoing urogynecological surgery and to suggest optimal methodologies for implementation.

OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial.

PURPOSE: Overactive bladder affects 12% to 17% of the general population and almost a third experience urinary incontinence, which may severely impact health related quality of life. Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects, leading to a high discontinuation rate. We report the results of the first large (557 patients), phase 3, placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics. MATERIALS AND METHODS: Eligible patients with overactive bladder, 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were randomized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo. Co-primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12. Secondary end points included other overactive bladder symptoms and health related quality of life. Adverse events were assessed. RESULTS: OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo (-2.65 vs -0.87, p <0.001) and 22.9% vs 6.5% of patients became completely continent. A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale (60.8% vs 29.2%, p <0.001). All other overactive bladder symptoms improved vs placebo (p ≤0.05). OnabotulinumtoxinA improved patient health related quality of life across multiple measures (p <0.001). Uncomplicated urinary tract infection was the most common adverse event. A 5.4% rate of urinary retention was observed. CONCLUSIONS: OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated.

Does physician specialty affect persistence to pharmacotherapy among patients with overactive bladder syndrome?

INTRODUCTION AND HYPOTHESIS: We compared persistence on overactive bladder (OAB) pharmacotherapy in patients treated in the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) department compared with patients treated in the Internal Medicine (IM) and General Urology (GU) departments within an integrated health-care system. We hypothesized that persistence would be higher among FPMRS patients. METHODS: This was a retrospective cohort study. Patients with at least one prescription for OAB between January 2003 and July 2014 were identified. Demographic, prescription and treatment specialty data and data on the use of third-line therapies were collected. The primary outcome was persistence, defined as days on continuous pharmacotherapy. Discontinuation was defined as a treatment gap of ≥45 days. Discontinuation-free probabilities were calculated using the Kaplan-Meier method and compared among the specialties. Predictors of persistence were estimated using logistic regression with adjustment for covariates. Pearson correlation coefficients were calculated to identify risk associations. RESULTS: A total of 252 subjects were identified. At 12 weeks, 6 months and 1 year, FPMRS patients had the highest persistence rates of 93 %, 87 % and 79 % in contrast to 72 %, 68 % and 50 % in GU patients, and 83 %, 71 % and 63 % in IM patients (p = 0.006, p = 0.007, p = 0.001, respectively). The median persistence in FPMRS patients was 738 days, in GU patients 313 days and in IM patients 486 days (p = 0.006). Of the FPMRS patients, 61 % switched to at least a second medication, as compared to 27 % of IM patients and 14 % of GU patients (p < 0.0001). CONCLUSIONS: Persistence on OAB pharmacotherapy was higher among FPMRS patients than among GU and IM patients in this community setting. These results suggest that persistence is higher under subspecialist supervision.

Which bladder instillations are more effective? DMSO vs. bupivacaine/heparin/triamcinolone: a retrospective study.

INTRODUCTION AND HYPOTHESIS: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a chronic and debilitating condition. Our objective was to compare two different bladder instillation treatments in patients with BPS/IC: dimethyl sulfoxide with triamcinolone (DMSO) vs. bupivacaine with heparin and triamcinolone (B/H/T). Our hypothesis was that both treatments are equally effective. METHODS: A retrospective cohort study of instillation-naïve patients was conducted comparing responses to either DMSO or B/H/T at our tertiary urogynecology center from 2012 to 2014. The primary outcome was patient-reported percent of overall improvement from baseline. Secondary outcomes were change in patient-reported daytime voiding frequency (hours) and change in number of nighttime voiding episodes. Variables analyzed as potential confounders included pelvic pain, cystoscopy findings, levator spasm, and fibromyalgia. The two-sided Student's t test, chi-squared test, Poisson regression, and repeated-measure analysis of variance (ANOVA) were used for analyses. RESULTS: One hundred and ninety-three eligible patients were identified (45 receiving DMSO, 146 receiving B/H/T). Compared with baseline, DMSO patients reported 63% improvement (p < 0.0001), increased time between daytime voids by 1.5 h (p < 0.00), and a 40% reduction in nocturia episodes (p < 0.00). B/H/T patients reported 51% improvement (p < 0.00), increased time between daytime voids by 1.4 h (p < 0.00), and an 8% reduction in nocturia episodes (p = 0.26). When comparing the two treatments, DMSO resulted in a greater percentage of overall improvement (p = 0.02) and a significant decrease in nocturia episodes when compared with B/H/T (p = 0.02). There was no significant difference between treatments for daytime voiding frequency (p = 0.50). CONCLUSION: Bladder instillations with DMSO or B/H/T provide overall symptomatic improvement and improved frequency and nocturia. DMSO appears to provide greater improvement in nocturia and overall.

Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study.

PURPOSE: These are the final results of the prospective, multicenter, long-term (3.5-year) study of the efficacy/safety of onabotulinumtoxinA for overactive bladder syndrome. MATERIALS AND METHODS: Patients who completed either of 2, 24-week phase 3 trials could enter a 3-year extension and continue treatment with onabotulinumtoxinA 100 U as needed to control overactive bladder symptoms. Data were analyzed by the treatment(s) received (up to 6) and in discrete subgroups that received 1, 2, 3, 4, 5 or 6 treatments (to evaluate the consistency of the response after repeat treatments in the same patient groups). Assessments included the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients who reported improvement/great improvement in urinary symptoms on the TBS (Treatment Benefit Scale) at week 12 as co-primary end points. Other end points were the change from baseline in I-QOL (Incontinence Quality of Life), the number of urgency and micturition episodes per day; duration of effect; the number of adverse events; and the initiation of intermittent catheterization. RESULTS: Consistent mean reductions in urinary incontinence were observed following continued onabotulinumtoxinA treatment, ranging from -3.1 to -3.8 in the overall population and -2.9 to -4.5 in the discrete subgroups. Durable improvements were seen in overactive bladder symptoms and quality of life. A high proportion of patients rated their condition as improved/greatly improved. The median duration of effect was 7.6 months. The most common adverse event was urinary tract infection. The rate of de novo catheterization after the first treatment was 4.0% and it ranged from 0.6% to 1.7% after subsequent treatments. CONCLUSIONS: Long-term onabotulinumtoxinA treatment consistently decreased overactive bladder symptoms and improved quality of life with no new safety signals.

Efficacy and safety of oxybutynin topical gel 3% in patients with urgency and/or mixed urinary incontinence: a randomized, double-blind, placebo-controlled study.

AIMS: To assess the efficacy and safety of oxybutynin transdermal gel 3% (OTG3%), with propylene glycol for enhanced skin permeation, in patients with urinary incontinence (UI). METHODS: In this phase 3 study, 626 patients ≥18 years old with urgency and/or mixed UI symptoms and predominantly urgency UI for ≥3 months were randomized 1:1:1 to receive 12 weeks of OTG3% 84 mg, OTG3% 56 mg, or placebo gel applied once daily to abdomen, inner/upper thigh, or upper arm/shoulder. Primary efficacy endpoint was change from baseline to Week 12 in weekly UI episodes recorded in 3-day bladder diaries. Results were compared using analysis of covariance. Adverse events (AEs) were monitored. RESULTS: Efficacy was assessed in 601 (intent-to-treat) and safety in 626 patients. At 12 weeks, OTG3% 84 mg/day achieved significantly greater improvement versus placebo in weekly UI episodes (mean change from baseline: -20.4 vs. -18.1; P < 0.05(a)), daily urinary frequency (-2.6 vs. -1.9; P = 0.001(b)), and urinary void volume (32.7 vs. 9.8; P < 0.0001(b)). Dry mouth, the most common treatment-related AE, occurred more often with OTG3% 84 mg/day (26/214 [12.1%]) vs. placebo (10/202 [5.0%]) (P = 0.028); 4 OTG3% patients withdrew because of dry mouth. Application site erythema occurred more often with OTG3% 84 mg/day (8/214 [3.7%]) versus placebo (2/202 [1.0%]) (P = NS); 12 OTG patients withdrew because of skin irritation. No serious treatment-related AEs occurred. CONCLUSIONS: OTG3% 84 mg/day was well tolerated and effective in improving urge incontinence or mixed UI symptoms with a predominance of UI in adults with overactive bladder.

Sexual function in women with anal incontinence using a new instrument: the PISQ-IR.

INTRODUCTION: Anal incontinence (AI) has been associated with sexual complaints. The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA Revised (PISQ-IR) has been validated to measure sexual function in sexually active (SA) and non-SA (NSA) women with pelvic floor disorders (PFD) including AI. We describe symptoms in women with PFDs including AI using this instrument. METHODS: This was a planned secondary analysis of data collected for the validation of the PISQ-IR. SA and NSA women with symptoms of pelvic organ prolapse, urinary incontinence (UI) and/or AI at 12 US and 5 UK sites were recruited. The Female Sexual Function Index (FSFI) and PISQ-IR were completed in addition to the Pelvic Floor Distress Inventory (PFDI), and other measures. RESULTS: Of 872 women enrolled, 90 (10%) reported AI. Compared with women without AI, women with AI were more likely to report stress UI (p = 0.007), urgency UI (p < 0.001), mixed UI (p < 0.001), diabetes (p = 0.036) and depression (p < 0.001), and to show larger genital hiatus measurements (p = 0.005) and more underactive pelvic floor muscles (p = 0.011). Furthermore, scores on the PFDI showed greater bother (p = 0.013), particularly the colorectal subscale (p < 0.001). While sexual activity was similar between the groups, FSFI desire (p = 0.016), PISQ-IR 'condition-specific' (p = 0.03) and 'global quality' (p = 0.046) domains were worse in women with AI. In logistic regression analysis, only the PISQ-IR 'condition-specific' domain was associated with AI when controlling for other confounders (OR 0.27, 95% CI 0.10 - 0.72, p = 0.009). CONCLUSIONS: Women with AI have similar rates of sexual activity but poorer sexual function than women without AI. The PISQ-IR may be most appropriate to characterize these conditions.