Nocturnal voiding frequency does not describe nocturia-related bother.

AIM: Nocturia frequency has been used as a measure of treatment efficacy for nocturia even though fluctuation of the symptom over time has been well described in the literature. Additionally, given the multifactorial causal pathway and clinically relevant comorbidities, frequency alone may be an insufficient marker of treatment direction. The aim of this study was to investigate factors associated with nocturia-related bother to identify additional variables that may capture the impact of nocturia, direct clinical care and have potential to quantify treatment outcome. METHODS: Prospective data from tertiary hospital Urology and Continence cohorts were matched for identical variables to generate a sample of 204 datasets. Descriptive statistics were obtained to describe the two cohorts. Characteristics of patients were evaluated across levels of nocturia frequency and nocturia-related bother using nonparametric methods; statistically significant differences between groups in each cohort were established. RESULTS: Nocturia frequency alone does not comprehensively reflect attributable bother. Five sleep variables (poor quality sleep, short time to first awakening to void, less than 7 hours of total sleep, primary sleep latency, and daytime sleepiness) and daily urinary urgency were significantly associated with high nocturia-related bother. Attributable bother, despite high-frequency nocturia, was minimized by male gender, lack of daily urinary urgency and good sleep quality. Poor health status, urinary urgency and sleep latency were associated with nocturia frequency. CONCLUSIONS: Items of importance to individuals with nocturia have been identified from patient data. These variables have the potential to sit alongside change in nocturia frequency as potential markers of treatment response.

Minimal Device Encrustation on Vesair Intravesical Balloons in the Treatment of Stress Urinary Incontinence: Analysis of Balloons Removed from Women in the SOLECT Trial.

INTRODUCTION: Encrustation of urinary biomaterials is common; however, the incidence of surface deposition on the Vesair® intravesical pressure-attenuation balloon has not been previously reported. The purpose of this analysis is to determine the incidence and potential risk factors for encrustation of the Vesair intravesical balloon. METHODS: The SOLECT trial is a prospective randomized controlled trial conducted at several European centers to evaluate the safety and efficacy of the Vesair balloon for the treatment of female stress urinary incontinence (SUI). Women included in the study demonstrated SUI symptoms for more than 12 months without complicating factors, such as history of recurrent urinary tract infections or nephrolithiasis. All balloons removed from women enrolled in the SOLECT trial were analyzed for surface characteristics and encrustation. Surface deposition severity was quantified and composition analyzed with infrared spectroscopy and scanning electron microscopy. Incidence of surface deposition was tabulated and risk factors analyzed. RESULTS: One hundred and five balloons removed from 75 women were included in this analysis. Measurable stone deposition of less than 1.5 mm was found on four balloons (3.8%), surface granules were noted on 42 (40.0%), surface film on 11 (10.5%), and both granules and film on two (1.9%). Analysis identified calcium oxalate both in measurable encrustation deposits as well as those with surface granulation. Pooled analysis found that dwell time was a risk factor for calcium deposition. CONCLUSION: The rate of encrustation on the Vesair intravesical balloon is low and does not appear to increase the rate of adverse outcomes or reduce clinical efficacy. FUNDING: Solace Therapeutics, Inc.

Older People's Preferences for Side Effects Associated with Antimuscarinic Treatments of Overactive Bladder: A Discrete-Choice Experiment.

INTRODUCTION: Understanding the importance older people attribute to the different side effects associated with oral antimuscarinic treatments for overactive bladder (OAB) could help inform prescribers, healthcare policy makers and the drug industry. OBJECTIVE: Our objective was to quantify the importance of the most prevalent cognitive and side effects of oral antimuscarinic treatments for OAB in older people. METHODS: We conducted a discrete-choice experiment (DCE) with the assistance of an interviewer with community-dwelling and hospitalized older people aged >65 years. The DCE involved two hypothetical drugs for imaginary OAB, with three levels of four side effects for each drug, and the International Consultation on Incontinence Questionnaire-Overactive Bladder and EuroQol 5-Dimensions (EQ-5D) questionnaire were also administered. Data were analysed using a conditional logit model. RESULTS: In total, 276 older people participated in the study. The median age was 75 years (interquartile range [IQR] 69-80), 63% were women and 21% had OAB syndrome. The most unwanted side effect in the choice of antimuscarinics for OAB was severe cognitive effects, followed by severe constipation, severe blurred vision, severe dry mouth, moderate cognitive effects and moderate constipation. Severe cognitive effects were at least 1.7 times as important as severe constipation. Exploratory subgroup analysis showed that none of the attributes was found to be significant in people who scored as anxious or depressed on the EQ-5D, and preferences about cognitive effects, constipation and blurred vision were equal in people with and without OAB. CONCLUSION: Older people attribute more importance to loss of cognitive function as a possible side effect of antimuscarinic treatment than to the three most prevalent possible side effects of this treatment.

A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females.

AIMS: Evaluate the efficacy, safety, and tolerability of a novel pressure-attenuation balloon for the treatment of female stress urinary incontinence (SUI) using a prospective, randomized, single-blind, multi-center design, evaluated at 3 months. METHODS: Sixty-three females with SUI were randomized 2:1 to treatment with a balloon (N = 41) or sham procedure (N = 22). The sham (control) entailed the same procedure without the deployment of a balloon. Endpoints were evaluated at 3 months and included a composite endpoint that required both ≥10 point increase in the 22-item Incontinence Quality of Life Survey (I-QOL) and ≥50% decrease in provocative pad weight. Additional endpoints included incontinence episode frequency, and PGII assessment. RESULTS: In an ITT analysis, 63% of women in the treatment group achieved the composite endpoint, compared to 31% in the Control Group (P = 0.0200). In a per protocol analysis, 81% of women in the treatment arm had a 50% decrease in pad weight test vs. 45% in the Control Group (P = 0.0143); 41.6% of the treatment patients were dry on pad weight test (≤1gram) vs. 0% in the Control Group (P < 0.001), and 58% of treated patients reported improvement on a PGII assessment versus 25% of women in the Control Group (P = 0.025). Adverse events in the treatment group included dysuria (14.6%), gross hematuria (9.8%), and UTI (7.3%). CONCLUSIONS: This minimally invasive treatment for female SUI with an intravesical pressure-attenuation balloon was safe and effective. The concept of pressure attenuation as a therapy for SUI is valid and feasible for those patients that can tolerate the balloon.

Onabotulinum toxin A for the treatment of neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis.

Evidence for the efficacy and safety of intravesical onabotulinum toxin A (onabotA) injections has led to it being licensed in many countries in patients with urinary incontinence due to neurogenic detrusor overactivity resulting from spinal cord injury and multiple sclerosis, who are refractory or intolerant to the gold-standard treatment, anticholinergics. Owing to its mechanism of action, an inhibitory effect on acetylcholine release is obtained for up to 10 months, with a recommended dose of 200 units. Urinary tract infections and postvoid residual volume are the most prevalent side effects. In the case of residual volume, clean intermittent catheterization might be necessary. In patients with spinal cord injury and multiple sclerosis, it is recommended to evaluate the manual dexterity and cognitive function before onabotA injections, to ensure that the patient and caregiver are able to perform catheterization if necessary. OnabotA treatment has a beneficial effect not only on urinary symptoms but also on quality of life.