Urinary Incontinence Clinical Trials

This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged/sustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment. TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®). The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum. Read Less

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS. Read Less

The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy. Read Less

A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence. Read Less

Identify the dry night rate in patients using the GoGoband® nocturnal enuresis device vs a standard Pflaundler bedwetting alarm. Read Less

Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies. The purpose of this study is to 1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system 2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy 3. To assess the cost-effectiveness of home biofeedback therapy. Read Less

This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to intermediate risk prostate cancer Prostate Cancer is currently managed with in a discrete fashion where patients either enroll in active surveillance protocols (No intervention) or undergo full intervention via whole gland treatments - most commonly radical surgery or radiation. These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and incontinence. Such events elicit significant and noticeable changes on a male lifestyle and for most prostate cancer tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk - focused on the organ sparing cancer lesion ablation, where organ function is preserved. The fundamental objective is to determine the tolerance and safety of TFA-LITT in men with low to intermediate risk prostate cancer, successful performed in the outpatient office-based setting under local anesthesia directed by fusion imaging. Secondary objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after TFA-LITT. Read Less