Faculty Bibliography

OBJECTIVE:To evaluate the effect of radiation on male stress urinary incontinence (SUI) and to assess the relative value of preoperative urodynamic (UDS) testing in radiated vs nonradiated men with SUI. METHODS:A retrospective chart review of all male patients with SUI who underwent UDS testing from 2010 to 2016 was performed. The impact of UDS findings on treatment decision making was assessed. UDS parameters and treatment patterns of radiated vs nonradiated patients were compared as well as the fates of storage symptoms in each group. RESULTS:Two hundred seven men were identified that underwent UDS with a clinical diagnosis of SUI. Sixty-five out of 207 (31.4%) were exposed to radiation as a treatment modality for prostate cancer. All patients that underwent UDS testing moved on to surgical correction of SUI, and the UDS findings did not alter plan to treat SUI in any patients. Men who were radiated prior to surgical correction of SUI were more likely to have detrusor overactivity (70% vs 38%, P <.0001) and had lower maximum cystometric capacity (255 vs 307.4 mL, P = .01) when compared to nonradiated on UDS. After artificial urinary sphincter or sling implantation, the proportion of patients requiring overactive bladder medications was higher in radiated vs nonradiated men (44.3% vs 25.3%; P = .01). CONCLUSION/CONCLUSIONS:Radiation therapy appears to increase the likelihood of bladder dysfunction in male patients with SUI. The UDS findings did not alter the plan to treat SUI in any patients in our series, and its role before SUI surgery in male patients, including those receiving radiation, may be limited.

Introduction & Objectives: Nocturia is a highly prevalent medical condition. Approximately 80% of patients with nocturia (average of >=2 nocturnal voids)have nocturnal polyuria (NP), and 21% also have overactive bladder (OAB). These patients report sleep disruption and negative effect on nighttime symptoms. First-line therapies for OAB, have limited efficacy in treating nocturia. Combination therapy with an antimuscarinic and an antidiuretic may provide better relief of nocturia for patients with this multifactorial pathophysiology. AV002 is an emulsified microdose desmopressin nasal spray indicated for the treatment of nocturia due to NP and may be suitable concomitant therapy for these patients. Material(s) and Method(s): Data from a subgroup of OAB patients with concomitant NP enrolled in two double-blind Phase 3 trials of AV002 for treatment of nocturia were pooled. Studies were approved by an institutional review board. Patients with >=2 nocturic voids for >=6 months received AV002 1.66 mcg, AV002 0.83 mcg, or placebo every night for 12 weeks. No fluid restrictions or behavioral modifications were required. Efficacy endpoints, based on patient voiding diaries, included first uninterrupted sleep period (FUSP; elapsed time from bedtime to first nocturic void). Patients in one trial also completed the validated Impact of Nighttime Urination (INTU)questionnaire to assess changes in quality of life (QoL; range, 0-100; 0, no impact; 100, greatest impact). Result(s): Of 1045 randomized NP patients, 275 with OAB were included in the FUSP analysis. Of these, 136 patients from one study were included in the INTU analysis. Baseline and change from baseline for FUSP and INTU are shown in Table 1. After 12 weeks of treatment, FUSP was extended to 4.0 hours and 3.9 hours in the AV002 1.66 mcg and 0.83 mcg groups, respectively (change from baseline, p<0.05 vs. placebo for each AV002 group). INTU overall impact scores were significantly improved in patients receiving AV002 compared with placebo. [Table Presented]Conclusions: AV002 treatment over 12 weeks significantly extended FUSP and improved INTU (QoL)scores compared with placebo in OAB patients with nocturia due to NP. AV002 may be an appropriate treatment for nocturia in patients with OAB and nocturia due to NP.

Objective: To report the current clinical features, treatment patterns and outcomes of female patients who were seen at a tertiary referral centre with a primary diagnosis of nocturia, and to assess the predictive factors of therapeutic management failure. Patients and methods: A retrospective chart review of all new female patients seen in a single-centre functional urology practice with the diagnosis of nocturia was performed. Up to three visits within a 12-month period from the time of presenting were reviewed. The primary endpoint was patient-reported improvement assessed at each follow-up visit and the change in the number of nocturia episodes. Results: In all, 239 female patients were included for analysis. The prevalence of nocturnal polyuria, reduced bladder capacity, and global polyuria were 75%, 40.2%, and 18.1%, respectively. Within the first two visits, 72.7% of patients had started a treatment beyond behavioural therapies. Anticholinergics were the most commonly initiated treatment (47.2% of patients). At the latest considered visit, 80 patients reported improvement in nocturia (45.5%) and there was a mean - 0.8 decrease in the number of nocturia episodes from 4 to 3.2, which was statistically significant (P < 0.001). There was no statistically significant association between any of the bladder diary findings and treatment outcomes. A smaller number of nocturia episodes was the only predictive factor of therapeutic management failure in multivariate analysis (odds ratio 0.10; P = 0.01). Conclusions: Whilst the prevalence of nocturnal polyuria in women with nocturia is high, the therapeutic management until 2016 seemed to rely mostly upon overactive bladder medications with a relatively low success rate. Abbreviations: BD: bladder diary; BPS: bladder pain syndrome; ICD(-9)-(10): International Classifications of Disease (ninth revision) (10th revision); NPI: Nocturnal Polyuria Index; OAB: overactive bladder; OR: odd ratio; POP: pelvic organ prolapse.

BACKGROUND:Nocturia is considered to be a very bothersome lower urinary tract disorder. Yet, to date, the economic burden attributable to this poor health condition remains less well known. OBJECTIVE:To compare differences in health care resource utilization (HCRU), health care costs, and work productivity in adult patients with differing frequencies of nocturia episodes (i.e., < 2 vs. ≥ 2 nocturia episodes per night). METHODS:Adult patients with nocturia enrolled in an integrated proprietary database were recruited to complete a survey on their demographics, nocturia characteristics, and work productivity. Using patients' survey data and health care claims from the previous 6 months, those with < 2 (n = 197; 21.9%) versus ≥ 2 (n = 702; 78.1%) nocturia episodes per night were compared for differences in HCRU, health care costs, and work productivity after adjusting for potential confounders. HCRU was reported as the mean number per patient per month (PPPM) for outpatient visits (all types), physician office visits, and prescriptions filled and the proportion of patients with ≥1 hospitalization or emergency department visit in the previous 6 months. Health care costs were reported as mean PPPM. Work productivity was assessed via patient survey and reported as a mean percentage for absenteeism, presenteeism, overall work impairment, and activity impairment during the past week. RESULTS:899 adult patients (mean age = 71.4 years; 57.2% men) were enrolled and analyzed. Compared with patients with <2 nocturia episodes per night, patients with ≥ 2 nocturia episodes had more outpatient health care visits (unadjusted mean visits PPPM: 2.1 vs. 1.6; P < 0.001; adjusted mean visits PPPM: 2.1 vs. 1.6; P = 0.017), office visits (unadjusted and adjusted mean visits PPPM: 0.9 vs. 0.7; P < 0.001), and prescriptions filled (unadjusted mean prescription fills PPPM: 3.1 vs. 2.1; P < 0.001; adjusted mean prescription fills PPPM: 3.2 vs. 2.2; P = 0.027). Patients with ≥ 2 nocturia episodes per night also displayed significantly higher outpatient health care costs (unadjusted mean PPPM costs: $676 vs. $516; P = 0.028; adjusted mean PPPM costs: $678 vs. $506; P = 0.017). In terms of work productivity impairment, patients with ≥ 2 nocturia episodes per night experienced higher rates of unadjusted (20% vs. 10%; P = 0.002) and adjusted presenteeism (20% vs. 10%; P = 0.004) and unadjusted (20% vs. 10%; P = 0.002) and adjusted overall work impairment (20% vs. 10%; P = 0.001). CONCLUSIONS:Study findings demonstrate that nocturia was associated with higher outpatient encounters and related costs in the presence of a greater occurrence of nocturic episodes. DISCLOSURES/UNASSIGNED:This study was funded by Allergan plc, Dublin, Ireland. Neither honoraria nor payments were provided for authorship. Dmochowski is a consultant and speaker for Allergan plc and a consultant for Serenity Pharmaceuticals. Brucker is a consultant and speaker for Allergan plc, a consultant for Watkins-Conti and Avadel, and an investigator for Medtronic and Ipsen. Cole is a consultant for Allergan plc and an employee of Sharp Rees-Stealy Medical Group. Kawahara and Pulicharam are full-time employees of DaVita Medical Group. Burk is a consultant for Allergan plc and a health outcomes consultant. Tung is an employee of Allergan plc. Hale has served as a consultant/advisor to and has received research funding from Allergan plc. The data from this manuscript were previously presented in poster format by Steve Kawahara at the Academy of Managed Care & Specialty Pharmacy Annual Meeting; April 19-22, 2016; San Francisco, CA.

Primary bladder neck obstruction (PBNO) is a functional obstruction caused by abnormal opening of the bladder neck during the voiding phase of micturition. PBNO may present with a variety of symptoms including voiding symptoms (slow urinary stream, intermittent stream, incomplete emptying), storage symptoms (frequency, urgency, urgency incontinence, nocturia), and/or pelvic pain and discomfort. The diagnosis of PBNO can be made with videourodynamic testing, which demonstrates elevated voiding pressures with low flow, and fluoroscopic imaging demonstrating obstruction at the level of the bladder neck. Treatment options include conservative management with watchful waiting, pharmacologic management, and surgical intervention. In this article, we review the etiology, presentation, diagnosis, and treatment of PBNO in men, women, and children.

The prevalence of nocturia in patients with multiple sclerosis (MS) is high, ranging from 20.9% to 48.8% in this population. Its underlying pathophysiology is complex and different from the non-neurogenic population. In the MS population, the pathophysiology may involve neurogenic lower urinary tract dysfunction (NLUTD) such as detrusor overactivity (NDO), detrusor-sphincter dyssynergia, or detrusor underactivity resulting in reduced bladder capacity. Nocturnal polyuria is also a significant contributor to the pathogenesis of nocturia in MS patients and may be the result of specific mechanisms such as nocturnal hypertension through autonomic cardiovascular dysfunction or lack of diurnal variation of antidiuretic hormone production (ADH) due to demyelinating lesions of the spinal cord. Nocturia might be particularly burdensome in MS patients by contributing to fatigue, a common and highly debilitating symptom in this population. There is likely a complex and multidirectional relationship between nocturia, other sleep disorders, and fatigue in the MS population that has yet to be explored. The assessment of nocturia in MS should rely upon a thorough history and physical examination. Urinalysis should be done to rule out urinary tract infection, a frequency-volume chart might help elucidating the underlying mechanisms, and post-void residual volume may be of interest to screen for urinary retention that could be asymptomatic in MS patients. Other tests such as urodynamics or polysomnography are indicated in selected patients. The treatment should be tailored to the underlying cause. The first steps involve behavioral interventions and treatment of cofactors. When possible, the predominant mechanism should be addressed first. In case of predominant NDO, antimuscarinics and beta-3 agonists should be offered as a first-line treatment and intradetrusor injections of botulinum toxin as a second-line treatment. In cases of incomplete bladder emptying, clean-intermittent self-catheterization is often used as part of multiple other interventions. In cases of nocturnal polyuria, desmopressin may be offered, inclusive of use of newer formulations (desmopressin acetate nasal spray, desmopressin orally disintegrated tablet) in countries where they are approved.