Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence
Urinary IncontinenceThe purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.
A Randomized Controlled Study Comparing Three Single-incision Devices for Female Urinary Stress...
Urinary IncontinenceThe prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized. Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP. Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
Urinary IncontinenceUrgeThe purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.
A 3 Year Follow-up Prospective Open Randomized Trial of TVT Versus Colposuspension for Primary Stress...
Urinary IncontinenceObjective: To compare TVT with COLPOSUSPENSION (CS) as primary treatment for stress incontinence (SUI). Design: Randomised, open, comparative trial 3-years follow-up. Participants: 49 consecutive 35 to 70 years old women with urodynamic SUI. Setting: Urology department of a district general hospital at Leganés (Madrid), Spain. Intervention: 24 patients randomised to TVT and 25 to CS.
Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of...
Overactive BladderUrinary IncontinenceThe purpose of this study is to assess the long term safety and effectiveness of botulinum toxin type A in treating patients with idiopathic overactive bladder with urinary incontinence.
Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease
Urinary IncontinenceParkinson's DiseaseBackground: Parkinson's disease affects up to 3% of persons over the age of 65. Lower urinary tract symptoms are a frequent cause of diminished quality of life in elderly persons and occur in up to 40% of persons with Parkinson's disease. While the exact mechanisms have not been determined, detrusor hyperactivity (hyperactivity of the bladder muscle) leading to symptoms of overactive bladder and urge incontinence is common. Behavioral and exercise-based therapies have relatively no side effects and have been shown to be an effective treatment for urge symptoms of overactive bladder in the aged population. Hypothesis and Specific Aims: Behavioral therapy using pelvic floor muscle exercises will result in a 50% decrease in the number of incontinence episodes in elderly persons (age > 50) with Parkinson's disease. The specific aims for this pilot study include the following: Complete a course of behavioral therapy using computer-assisted biofeedback in 20 subjects with UI associated with PD and determine how many potential subjects need to be screened and enrolled to achieve this sample size. Determine the proportion of these patients who achieve a 50% or greater reduction in UI episodes. Examine whether responsiveness is associated with characteristics of the Parkinson's disease, in particular disease severity as measured by the Unified Parkinson's Disease Rating Scale (UPDRS). Assess the effectiveness of behavioral therapy without the use of computer-assisted biofeedback instruction in 10 additional subjects with PD and UI. Methods: The first 20 participants will be enrolled in an 8-week treatment trial of behavioral therapies and pelvic floor muscle exercises with computer-assisted biofeedback. Ten additional participants will be enrolled in the 8-week treatment trial of behavioral therapy, but will not have computer-assisted biofeedback. Voiding diaries as well as urinary symptom and quality of life questionnaires will be used to assess response. If persons with Parkinson's disease can complete the treatment trial and achieve a reduction in episodes of urinary incontinence with behavioral techniques this would lay the foundation for a larger, placebo-controlled trial. Assessment of responsiveness associated with severity of Parkinson's disease would also provide important information about the utility of this treatment strategy.
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Overactive Bladder With Symptoms of FrequencyUrgency1 moreThis study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine in healthy adult subjects.
Value of Urodynamics Prior to Stress Incontinence Surgery
Stress Urinary IncontinenceTo test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.
Efficacy and Safety Stress Urinary Incontinence Study
Urinary IncontinenceStressStudy F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a clinical diagnosis of SUI.
Urge Incontinence Bladder Overactivity Study
Urinary IncontinenceExamine the efficacy and safety of duloxetine in subjects with symptoms of bladder overactivity due to pure detrusor instability or sensory urgency. Subjects in study will be permitted to escalate or de-escalate between 80 mg/day and 120 mg/day in consultation with the investigator and based on their adverse events.