Effect of Dietary Choline Consumption on the Development of Urinary Urgency Incontinence in a Longitudinal Cohort of Women.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to determine whether differences in the cumulative dietary intake of choline, is associated with the risk of developing urge urinary incontinence (UUI). METHODS: This was an analysis within the Nurses' Health Study (NHS) I and II. The main exposure was the cumulative daily intake for each choline-containing compound obtained from a detailed daily food frequency questionnaire. The primary outcome was UUI, defined as urine loss with a sudden feeling of bladder fullness or when a toilet is inaccessible, occurring >1/month. Cox proportional hazards regression models were used to calculate multivariate-adjusted relative risks and 95% confidence intervals (CIs) for the association between total choline and choline derivatives and risk of UUI. Fixed effects meta-analyses of results from NHSI and NHSII were performed for postmenopausal women only to obtain a pooled estimate of the impact of choline consumption on UUI. RESULTS: There were 33,273 participants in NHSI and 38,732 in NHSII who met all the criteria for inclusion in the analysis. The incidence of UUI was 9.41% (n=3,139) in NHSI and 4.25% (n=1,646) in NHSII. After adjusting for confounders choline was not found to be associated with UUI in postmenopausal women. However, in premenopausal women, relative to the lowest quartile, the highest quartile of consumption of total choline (aRR = 0.79, 95% CI: 0.64-0.99), free choline (aRR = 0.74, 95% CI: 0.58-0.94), and phosphocholine (aRR = 0.77, 95% CI: 0.61-0.96) were associated with a reduced risk of UUI. CONCLUSIONS: Increased dietary choline consumption was associated with a reduced risk of UUI among premenopausal women.

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study.

AIMS: Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up. METHODS: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB-q) at baseline and follow-up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device-, procedure-, or therapy-related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB-q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. RESULTS: Sixty-eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3- and 6-month follow-up visits, respectively. The OAB-q HRQL demonstrated a statistically significant improvement from baseline to 3-month follow-up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6-months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3- and 6-month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3-month (92.5%, 62/67) and 6-month (89%, 59/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow-up in UUI episodes/day was -3.6 (95% CI: -4.7, -2.6; n = 62) at 3-month and -3.7 (95% CI: -4.7, -2.7; n = 61) at 6-month. Among subjects with urgency-frequency (UF), the average change from baseline to follow up in voids/day was -4.5 (95% CI: -6.3, -2.7; n = 52) at 3-months and -4.4 (95% CI: -6.0, -2.7; n = 52) at 6-month. The cumulative incidence of device-, procedure-, or therapy- related adverse events was 7.4% (5/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot. CONCLUSIONS: These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB-q HRQL score at 3-month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.

Total fluid intake, caffeine, and other bladder irritant avoidance among adults having urinary urgency with and without urgency incontinence: The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

INTRODUCTION: Caffeine has long been vilified as a cause for urinary urgency incontinence (UUI) along with other potential bladder irritants such as carbonation, alcohol, and acidic juices. The objective of this study was to assess the fluid intake behavior of people with urgency, UUI, and those with lower urinary tract symptoms (LUTS) without UUI or urgency to assess if they avoided certain potential bladder irritants or had different fluid intake. We hypothesized that patients with UUI would avoid caffeine as a self-management method more so than these other two groups. METHODS: Treatment-seeking men and women with LUTS in the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Observational Cohort study completed a baseline 3-day voiding and intake diary. "Complete" diaries had 3 days of data and no missing intake or voided volumes. Beverages with any caffeine, alcohol, carbonation, or acidic juice were identified and the total volume was recorded as well as the type of beverage containing caffeine to calculate the daily caffeine dose. RESULTS: Four hundred and ninety-one participants (277 men and 214 women) with a median age of 63 had complete diaries. Urinary urgency was more prevalent in women than men (79% vs. 55%, p < 0.0001) as was UUI (84% vs. 47%, p < 0.0001). Total fluid intake over 3 days was lower among the urgency group versus the nonurgency group (median [interquartile range] 5.2 [4.0-6.8] L vs. 5.7 [4.3-7.0] L, p = 0.028) and the UUI group compared to the urgency without incontinence group were less likely to consume alcohol (26% vs. 37%, p = 0.04). After adjusting for sex, BMI, age, and total intake volume, UUI participants had 54% lower odds of consuming any caffeine (odds ratio = 0.46, 95% confidence interval = 0.22-0.96, p = 0.04) than those without incontinence, but among those that did consume caffeine, no difference in the volume of caffeinated beverages or milligrams of caffeine consumed was detected between those with UUI and those with urgency without incontinence. No difference in carbonation or acidic juice intake was detected between groups. CONCLUSIONS: Individuals with urgency consume a lower volume of fluid than those without urgency. UUI participants more often abstain from caffeine, but among those that consume caffeine, the dose is similar to those without UUI. One explanation for these results is that only a subset of individuals with urgency or UUI are caffeine sensitive.

Cognitive impairment does not impact sacral neuromodulation implant rates for overactive bladder.

OBJECTIVE: To evaluate the impact of cognitive impairment (CI) diagnoses on sacral neuromodulation (SNM) outcomes in older patients. MATERIALS AND METHODS: We completed a retrospective review of all patients aged ≥55 years who underwent test-phase SNM (peripheral nerve evaluation (PNE) or stage 1) for overactive bladder (OAB) between 2014 and 2021 within a large multi-regional health system. Patient demographics, relevant comorbidities, CI diagnoses (dementia or mild CI), and SNM procedures were recorded. Logistic regression modeling was performed to evaluate the impact of CI on SNM implantation rates. RESULTS: Five-hundred and ten patients underwent SNM test phase (161 PNE, 349 Stage 1) during the study period. The mean age was 71.0(8.5) years, and most (80.6%) were female. Overall, 52(10.1%) patients had a CI diagnosis at the time of SNM, and 30 (5.8%) were diagnosed at a median of 18.5 [9.25, 39.5] months after SNM. Patients with CI diagnoses were older, with more comorbidities, and were more likely to undergo PNE. Univariable comparison found no difference in implantation rate based on pre-SNM CI (85.4% vs. 76.9%, p = 0.16). Multivariable analysis identified PNE (OR 0.43, 95% CI 0.26-0.71), age (OR 0.96, 95%CI 0.93-0.98), and prior beta-3 agonist use (OR 0.60, 95% CI 0.37-0.99) but not CI or dementia as independent negative predictors of implantation. Implanted patients had a median follow-up of 25 [12.0, 55.0] months. Explant and revision rates did not differ according to CI. CONCLUSION: Patients with OAB and CI diagnoses proceed to SNM implant at rates similar to patients without CI diagnoses. A diagnosis of CI should not necessarily exclude patients from SNM therapy for refractory OAB.

Urinary tract infection following intradetrusor onabotulinumtoxina injection for non-neurogenic urgency incontinence: single- vs. multi-dose prophylactic antibiotic treatment regimens.

INTRODUCTION AND HYPOTHESIS: Urinary tract infection is one of the most common adverse events following onabotulinumtoxinA injection for urgency incontinence. Our hypothesis was that those undergoing injection for urgency incontinence who received more than one dose of prophylactic antibiotics have lower post-procedure urinary tract infection rates compared to those who receive a single dose. METHODS: We conducted a multi-center retrospective cohort study in females who underwent onabotulinumtoxinA injection for non-neurogenic urgency incontinence to evaluate the effect of single- vs. multi-dose prophylactic antibiotic regimens on the risk of post-procedure urinary tract infection. The primary outcome was the rate of urinary tract infection within 30 days of injection. Our sample size calculation required 136 subjects per group. RESULTS: Two hundred eighty-one patients were included from four centers. The single-dose cohort included 145 patients (51.6%), and the multi-dose cohort included 136 patients (48.4%). The mean age was 65 years, and patients were primarily Caucasian (81.4%). There was no difference in the rate of urinary tract infections diagnosed within 30 days of injection between the cohorts (single dose 13.8% vs. multi-dose 10.3%, p = 0.369). Those with a positive urine culture within 30 days of injection had a 15.2 times greater odds of having a post-procedure infection than those who did not (95% CI 3.19-72.53). There was no significant difference between the two cohorts in terms of adverse health events following injection. CONCLUSIONS: In females with non-neurogenic urgency incontinence undergoing onabotulinumtoxinA injection, multi-dose prophylactic antibiotic regimens were not associated with lower post-procedure urinary tract infection rates.

The influence of age and health status for outcomes after mid-urethral sling surgery-a nationwide register study.

INTRODUCTION AND HYPOTHESIS: The efficacy of mid-urethral sling (MUS) surgery in older women and women with a significant disease burden is limited. We aimed to determine the influence of chronological age and physical status (assessed by the American Society of Anesthesiologists Physical Status, ASA) classification on outcomes. METHODS: Cure rate, change in frequency of lower urinary tract symptoms, satisfaction, impact, and adverse events after MUS surgery were assessed in 5200 women aged 55-94 years with MUS surgery (2010-2017). Data were analysed by multivariate logistic regression and Mantel-Haenszel chi-square statistics. RESULTS: The cure rate was 64.2% (95% CI, 60.0-68.4) in the ≥ 75-year cohort compared to 88.5% (95% CI, 87.1-89.8) in the 55-64-year cohort (trend p < 0.0001). The estimated probability of cure, improvement, and satisfaction with the procedure decreased by aOR10yr = 0.51 for cure to aOR10yr = 0.59 for satisfaction (all p < 0.0001). Women with a significant health burden (ASA class 3-4) had lower cure rates and satisfaction than those without (65.5% vs. 83.7%, p < 0.0001 and 65.7% vs. 80.6%, p < 0.0001). Older age was more likely to be associated with de novo urgency (p = 0.0022) and nocturia ≥ 2 (p < 0.0001). Adverse events, readmission, and 30-day mortality rates were low. Women, irrespective of age, were equally satisfied if they experienced a decrease of at least one step in leakage frequency. CONCLUSIONS: Even if MUS surgery in older women and those with ASA class 3-4 was associated with a lower cure rate and less satisfactory outcome, a majority were satisfied provided they experienced a reduction of incontinence episodes.

Characterizing persistent urinary incontinence after successful fistula closure: the Uganda experience.

BACKGROUND: Obstetric fistula is a devastating childbirth injury. Despite successful closure of the fistula, 16% to 55% of women suffer from persistent urinary incontinence after surgery. OBJECTIVE: This study assessed the type and severity of persistent incontinence after successful fistula closure and its impact on the quality of life of Ugandan women post-fistula treatment. STUDY DESIGN: This cross-sectional study enrolled women with a history of obstetric fistula repair who continued to have persistent urinary incontinence (cases, N=36) and women without incontinence (controls, N=52) after successful fistula closure. Data were collected in central and eastern Uganda between 2017 and 2019. All the participants completed a semistructured questionnaire. Cases underwent a clinical evaluation and a 2-hour pad test and completed a series of incontinence questionnaires, including two novel tools designed to assess the severity of incontinence in low-literacy populations. RESULTS: Cases were more likely to have acquired a fistula during their first delivery (63% vs 37%, P=.02), were younger when they developed a fistula (20.3±5.8 vs 24.8±7.5 years old, P=.003), and were more likely to have had >2 fistula surgeries (67% vs 2%, P≤.001). Cases reported a much higher rate of planned home birth for their index pregnancy compared to controls (44% vs 11%), though only 14% of cases and 12% of controls actually delivered at home. Cases reported higher rates of pain with intercourse (36% vs 18%, P=.05), but recent sexual activity status (intercourse within the previous six months) was not significantly different between the groups (47% vs 62%, P=.18). Among cases, 67% reported stress incontinence, 47% reported urgency incontinence, and 47% reported mixed incontinence. The cough stress test was successfully done with 92% of the cases, and of these, almost all (97%) had a positive cough stress test. More than half (53%) rated their incontinence as "very severe," which was consistent with objective findings. The 24-hour voiding diary indicated both high urinary frequency (average 14) and very frequent leakage episodes (average 20). Two-hour pad-tests indicated that 86% of cases had >4 g change in pad weight within 2 hours. Women with more severe incontinence reported a more negative impact on their quality of life. The mean score of the International Consultation on Incontinence Questionnaire-Quality of Life was 62.77±12.76 (range, 28-76, median=67), with a higher score indicating a greater impact on the quality of life. There was also a high mental health burden, with both cases and controls reporting high rates of suicidal ideation at any point since developing fistula (36% vs 31%, P=.67). CONCLUSION: Women with obstetric fistulas continue to suffer from severe persistent urinary incontinence even after successful fistula closure. Both stress and urgency incontinence are highly prevalent in this population. Worsening severity of incontinence is associated with a greater negative impact on the quality of life.

The patient pathway for overactive bladder management: A quantitative analysis.

PURPOSE: We aimed to explore the pathways followed by patients with overactive bladder (OAB) from referral to the urologist to final treatment. METHODS: This was a single-center, retrospective cohort study of female patients diagnosed with OAB in a large Dutch nonacademic teaching hospital. The number, sequence, and duration of treatment steps offered were analyzed, and the effectiveness, reasons for discontinuation, and possible case-mix variables influencing OAB treatment were studied. RESULTS: In total, 120 patients were enrolled and required a median of 2 steps (range, 1-6) of treatment over a median total duration of 28 weeks (range, 5-256). Treatment typically started with drug therapy, including antimuscarinics (38%; 95% CI, 30%-47%), antimuscarinics plus pelvic floor muscle therapy (21%; 95% CI, 15%-29%), or mirabegron (11%; 95% CI, 6%-18%). However, 52% of patients required further treatment, with botulinum toxin A (BoNT-A) injections being most effective (67%; 95% CI, 42%-85%), followed by antimuscarinics plus percutaneous tibial nerve stimulation (50%; 95% CI, 25%-75%), and antimuscarinics plus pelvic floor muscle therapy (36%; 95% CI, 21%-54%). Other therapies showed lower effectiveness. Common reasons for discontinuation were insufficient response and side effects. Overall, 22 patients were lost to follow-up. CONCLUSION: Most patients try at least two treatments before they experience satisfactory symptom relief, with treatment evaluations requiring time because therapeutic onsets differ by patient and treatment. Our data can help to manage expectations among urologists and patients when seeking treatment for OAB.

SUFU white paper on overactive bladder anticholinergic medications and dementia risk.

AIMS: Anticholinergic medications are widely used in the treatment of overactive bladder (OAB), as well as for short-term treatment of bladder symptoms following a variety of urologic surgeries. Mounting evidence points to an association between anticholinergic medications and the increased risk of incident dementia. The Society for Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) thus convened a committee of subject experts to contextualize the current understanding of the cognitive risks of anticholinergic medications in the urologic patient population and to provide practical clinical guidance on this subject. METHODS: Statements are based on an expert literature review and the committee's opinion. The document has been reviewed and approved by the SUFU board. RESULTS: Chronic use (>3 months) of OAB anticholinergic medications is likely associated with an increased risk of new-onset dementia. Short-term (<4 weeks) use of most OAB anticholinergic medications is likely safe in most individuals. Clinicians should consider potential cognitive risks in all patient populations when prescribing OAB anticholinergics for chronic use. Consideration should be given to progressing to advanced therapy (botulinum toxin or neuromodulation) earlier in the OAB treatment paradigm CONCLUSIONS: The current body of literature supports a likely small but significant increased risk of dementia with chronic exposure to OAB anticholinergic medications. Potential harms should be balanced against potential quality of life improvement with treatment.

Evaluation of the relationship of cholinergic metabolites in urine and urgency urinary incontinence.

INTRODUCTION AND HYPOTHESIS: To investigate differences in urine cholinergic metabolites in women with urinary urgency incontinence (UUI) and responders (R) and non-responders (NR) to anti-cholinergic medications (AC). METHODS: Patients with UUI and age-matched controls were evaluated pre- and post-treatment using OABSS, UDI-6 and IIQ-7. Controls were defined as having a cumulative OABSS of zero. Patients with UUI were treated with AC and followed for 12 weeks. Responders were those with a > 50% decrease in the total OABSS score. Urine samples were collected from all participants for evaluation. Metabolite detection was accomplished using commercial assay kits. Wilcoxon-rank sum test and Fisher's exact test were used to express differences between groups. Spearman's rho correlation coefficient was used to determine the relationship between acetylcholine (Ach), choline (Ch), acetylcholinesterase (AchE) and questionnaire scores. RESULTS: We recruited 39 with UUI and 33 controls. We found concentrations of Ch [29.0 (IQR: 24.2-42.5) µmol vs. 15.2 (IQR: 7.5-24.1) µmol] and Ach [65.8 (IQR: 30.4-101.8) nmol and 33.1 (IQR: 11.9-43.8) nmol] were higher in the UUI group compared to controls (p = 0.003 and p < 0.001, respectively] and no differences in AchE concentrations. In the UUI group, 43.6% responded to AC after 12 weeks of therapy. There were no differences in Ch or AchE levels between R and NR; Ach levels were higher in the R group [82.1 nmol (IQR: 54.8-118.1) vs. 50.3 nmol (IQR: 29.9-68.2), p = 0.007]. Ch and Ach were positively associated with pre-treatment OABSS parameters. CONCLUSIONS: Urine Ach is higher in responders to anti-cholinergic therapy, and urine cholinergic metabolites were higher in the UUI patients compared to controls.

Neuromuscular urethral function and urethral urodynamic parameters between urgency and stress incontinence do not differ.

INTRODUCTION AND HYPOTHESIS: To describe and compare urethral neuromuscular function using concentric needle electromyography (CNEMG) and urodynamic (UDS) parameters between stress incontinent (SUI) and urge incontinent (UUI) women. METHODS: Incontinent women were recruited from a urogynecology clinic if they answered "sometimes" or "always" to one of the items on the Medical, Epidemiologic, and Social Aspects of Aging questionnaire. Participants were categorized by MESA scores into stress (SUI) or urgency (UUI) incontinence groups. Participants underwent CNEMG of the striated urethral sphincter at three insertion sites using Medtronic multiple motor unit action potential analysis. UDS was performed with Laborie microtip catheters: urethral pressure profiles were obtained at baseline and 300 ml. Data were analyzed in SPSS. Continuous variables were compared with independent t-test or Mann-Whitney U, categorical variables with chi-square test. A logistic regression was performed to control for variables found to be significant on univariate analysis. RESULTS: Fifty-six women (37 SUI, 19 UUI) with mean ± SD age of 53 ± 13 years participated. At baseline, patients with SUI were younger, more likely to be premenopausal and had lower BMIs. There were no differences in urethral EMG or UDS parameters between UUI and SUI women except lower maximum cystometric capacity in women with UUI. When controlling for age, BMI and MCC on logistic regression, there remained no differences between SUI and UUI groups on EMG or UDS parameters. CONCLUSIONS: Women with UUI and DO show similar evidence of denervation-reinnervation injury to the striated urethral sphincter muscle as women with SUI.

Prevalence and trends in urinary incontinence among women in the United States, 2005-2018.

BACKGROUND: Women are disproportionately affected by urinary incontinence compared with men. Urinary incontinence results in physical and psychological adverse consequences and impaired quality of life and contributes to significant societal and economic burden. Previous studies reported high urinary incontinence burden in the United States. However, the current prevalence and recent trends in urinary incontinence and its subtypes among US women have not been described. In addition, correlates of urinary incontinence among US women have not been systematically evaluated in the contemporary population. OBJECTIVE: The purpose of this study was to determine the prevalence and trends in urinary incontinence among adult women in the United States from 2005 to 2018. In addition, this study aimed to investigate the relationship of urinary incontinence subtypes with several sociodemographic, lifestyle, health-related, and gynecologic factors. STUDY DESIGN: We used data from the National Health and Nutrition Examination Survey, a nationally representative series of surveys that was designed to evaluate the health status of the US population. Data on urinary incontinence from 7 consecutive 2-year cycles (2005-2006 to 2017-2018) were used for this study. A total of 19,791 participants aged ≥20 years were included. Weighted prevalence estimates and 95% confidence intervals were calculated in each study cycle for stress, urgency, and mixed urinary incontinence. Multivariate-adjusted weighted logistic regression was used to investigate the temporal trends in urinary incontinence, in addition to determining the association between urinary incontinence subtypes with several participants' factors. RESULTS: In the 2017-2018 cycle, stress urinary incontinence was the most prevalent subtype (45.9%; 95% confidence interval, 42.1-49.7), followed by urgency urinary incontinence (31.1%; 95% confidence interval, 28.6-33.6) and mixed urinary incontinence (18.1%; 95% confidence interval, 15.7-20.5). The prevalence rates of urgency and mixed urinary incontinence were higher in women aged 60 years and older (urgency, 49.5% [95% confidence interval, 43.9-55.2]; mixed, 31.4% [95% confidence interval, 26.2-36.6]) than in those aged 40 to 59 years (urgency, 27.9% [95% confidence interval, 23.6-32.1]; mixed, 15.9% [95% confidence interval, 12.9-19.0]) and those aged 20 to 39 years (urgency, 17.6% [95% confidence interval, 13.8-21.5]; mixed, 8.3% [95% confidence interval, 5.4-11.3]). The overall prevalence of stress and mixed urinary incontinence was stable throughout 2005 to 2018 (both Ptrend=.3), with increases in mixed urinary incontinence among women aged 60 years and older (P=.001). The prevalence of urgency urinary incontinence significantly increased, particularly among women aged 60 years and older (both P=.002). Age, obesity, smoking, comorbidities, and postmenopausal hormone therapy were associated with higher prevalence of all types of urinary incontinence. Black women were less likely to report stress urinary incontinence but more likely to report urgency urinary incontinence. CONCLUSION: Although the estimated overall prevalence of stress and mixed urinary incontinence remained stable from 2005 to 2018, the prevalence of urgency and mixed urinary incontinence significantly increased among women aged 60 years and older. All subtypes of urinary incontinence were higher among women with obesity and comorbidities, those who used postmenopausal hormone therapy, and those who smoke.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

Testing a new, intensified infusion-withdrawal protocol for urinary urgency provocation in brain-bladder studies.

INTRODUCTION: The brain's role in bladder control has become an important area of study in the last 15 years. Typically, the brain's role in urinary urgency has been studied by repeated infusion and withdrawal of fluid, per catheter, to provoke urgency sensation during a whole brain magnetic resonance imaging (MRI) scan. Since this technique generally requires a large group size, we tested a more intense infusion-withdrawal protocol in an attempt to improve signal to noise ratio and repeatability of the signal which would, in turn, allow us to further probe subtypes of urgency urinary incontinence. METHODS: A total of 12 women over the age of 60 were recruited to test a new "intense" infusion withdrawal protocol. They underwent this new protocol during a functional brain MRI scan. The primary outcome was comparison of activity within the insula, medial pre-frontal cortex and dorsal anterior cingulate cortex/supplementary motor area (dACC/SMA). Immediate test-retest repeatability was measured using intraclass correlation. Secondary exploratory evaluation of differences in the whole brain between protocols was conducted. RESULTS: There was no significant difference in signal in any of the a priori regions of interest between protocols. Test-retest repeatability in the new protocol was poor compared to the original protocol, and variability was higher. Three participants were not able to tolerate the "intense" protocol. CONCLUSION: The small improvement in signal to noise ratio of the new protocol was not sufficient to overcome the poorly tolerated intense filling protocol.

Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial.

AIMS: To compare the effectiveness and safety of polypropylene (PP) and polyvinylidene fluoride (PVDF) transobturator tapes (TOT) for the treatment of female stress urinary incontinence (SUI). METHODS: This is a multicentre randomized trial. Women with SUI or stress-predominant mixed urinary incontinence and scheduled for a TOT procedure were randomized to PP or PVDF slings. The primary outcome was 1-year cure or improvement rate using composite criteria. Complications were also compared. Relationships with outcomes were analyzed using multivariable logistic regressions models. RESULTS: From April 2016 to January 2018 285 participants were randomized. PP and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%, p = .138). Improvement in validated questionnaires was also similar. PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15-0.80). We found no statistical differences in complications rates, although a higher incidence of long-term pain events were observed in the PP group. The study is underpowered to find differences in specific complications owing to the low number of events. CONCLUSION: PP and PVDF TOTs are equally effective, although PVDF is associated with fewer cases of de novo urgency incontinence. Further studies are needed to give robust conclusions on safety profiles.

Validation and cultural translation for the Brazilian Portuguese version of the Questionnaire for Urinary Incontinence Diagnosis.

INTRODUCTION AND HYPOTHESIS: Short questionnaires are important for validating the clinical diagnosis of urinary incontinence (UI). We sought to validate and culturally translate the Questionnaire for Urinary Incontinence Diagnosis (QUID) for the Brazilian Portuguese language. METHODS: A cross-sectional study with 457 women (330 with urinary incontinence and 127 controls) was performed in a Southeastern Brazilian outpatient clinic. Patients answered a pilot-tested, notarized, six-item questionnaire (QUID) for internal consistency as well as a control questionnaire (ICIQ-SF and ICIQ-OAB) for construct validity. In both groups, floor and ceiling effects were calculated. Within UI women, test-retest (n = 41) and responsiveness to conservative treatment (n = 74) were also analyzed. RESULTS: Internal consistency (Cronbach's alpha) from the QUID was adequate between the UI (0.845-0.850) and control (0.724-0.775) groups. Mean QUID scores were statistically different between UI and control groups (p < 0.05). No ceiling or floor effects were observed in incontinent patients. Test-retest reliability after 4 weeks (intraclass correlation coefficient [ICC]: 0.780-0.814) and responsiveness (0.867-0.889) were also adequate within UI women. Construct validity was adequate at all correlations between QUID and ICIQ-SF and ICIQ-OAB (r: 0.19-0.58; p <0.05). Responsiveness was demonstrated by a statistically significant difference in questions/subscale sores after physical therapy. CONCLUSION: The QUID presented adequate cultural translation, reliability, and good responsiveness to treatment in the Brazilian Portuguese language.

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.

Sacral neuromodulation: sacral anatomy and optimal lead placement.

INTRODUCTION AND HYPOSTHESIS: To develop an instructional video that correlates cadaveric anatomy with fluoroscopic images to assist in conceptualization of optimal placement of the foramen needle and lead to complete an efficient and successful sacral neuromodulation (SNM) procedure. METHODS: A SNM procedure was performed and recorded on a fresh female cadaver. Fluoroscopic images were obtained during the procedure to highlight the bony relationships to the S3 foramen and nerve. Dissection of the anterior and posterior sacrum was completed to highlight the tract of the S3 nerve. Techniques to increase the likelihood of optimal foramen needle and thus lead placement were highlighted. CONCLUSIONS: This video demonstrates how achieving optimal foramen needle placement within the S3 foramen is key to optimal lead placement. Understanding the relationship of the bony landmarks on fluoroscopy to the S3 nerve and foramen, seen in the cadaveric dissections, are important in understanding how to achieve optimal lead placement. This optimization should lead to decreased operating room time, maximization of programming options, and decreased amplitude requirements.

Sacral neuromodulation: troubleshooting needle placement.

INTRODUCTION AND HYPOTHESIS: The objective was to develop an instructional video that utilizes fluoroscopic images and anatomical landmarks to increase the surgeon's ability to troubleshoot optimal placement of the foramen needle and lead during a stage I sacral neuromodulation (SNM) procedure. METHODS: Eight different examples of suboptimal foramen needle placement with subsequent corrections during a SNM procedure were performed and recorded on a fresh female cadaver. RESULTS: Fluoroscopic images were obtained during the procedure, and illustrations of the posterior aspect of the sacrum highlighting the S3 foramina and nerve are shown for anatomical comparison. CONCLUSIONS: This video demonstrates how to efficiently identify and correct suboptimal foramen needle placement in order to obtain optimal lead placement during an SNM procedure. Understanding the relationship between the bony landmarks on fluoroscopy and the S3 nerve and foramen are important in order to understand how to correct a suboptimal foramen needle and thus achieve optimal lead placement.

Overactive bladder and urgency urinary incontinence in men undergoing artificial urinary sphincter placement.

PURPOSE: To assess persistent and de novo rates of overactive bladder (OAB) and urgency urinary incontinence (UUI) in patients with incontinence after prostate treatment (IPT) focusing on differences between surgical intervention vs radiation. METHODS: We performed a retrospective review of 79 patients who underwent primary artificial urinary sphincter (AUS) placement and activation from a single surgeon between February 2012 and November 2017. Four patients with neurogenic bladder were excluded and two with insufficient follow-up. The primary outcome measures were persistent OAB, persistent UUI, and pad usage before and after AUS placement. RESULTS: After activation of the AUS, 67% of non-radiated patients had resolution of urgency incontinence vs only 31% of the radiated patients (P = .096). After activation of the AUS, resolution of OAB symptoms was more common in the non-radiated group. We found 53% of the non-radiated group vs only 22% of the radiated group had resolution of their urinary urgency (P = .045). Previous history of radiation was a risk factor for OAB after implantation of AUS (odds ratio [OR], 3.63; P = .010). Postoperative oral medical pharmacotherapy for OAB was higher in those with previous radiation vs those without prior radiation (66.7% vs 25.7%, P = .001). A history of OAB or UUI did not affect social continence after AUS placement. CONCLUSION: Radiation is a risk for continued OAB after AUS activation. Appropriate counseling is necessary pre- and postoperatively to manage patient expectations and provide additional medical therapies. Mixed urinary incontinence or OAB symptoms should not exclude patients from undergoing AUS placement.