INTIBIA Pivotal Study
Urinary IncontinenceUrge6 moreProspective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation...
Urinary IncontinenceUrgeThis is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system. Subjects from both groups will immediately start with therapy. The primary endpoint is a ≥ 50% reduction in number of incontinence episodes associated with urgency at the 3-month visit, with additional measurements assessed at 14 days, 1, 6, 9 and 12-months.
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary IncontinenceUrge Incontinence6 moreUCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)...
Overactive BladderUrge Incontinence3 moreThe goal of this prospective, multicenter, single-arm study is to test the safety and effectiveness of eCoin ® tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The main questions it aims to answer are: The proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary (72 hours) after 12 months of therapy. The rate of device- or procedure-related AEs through 12 months post-activation of eCoin ®. Participants will be implanted with eCoin ® and complete voiding diaries and patient reported-outcomes through 12 months of eCoin ® therapy.
Effect of Tibial Transcutaneous Electrostimulation in Women With Urgency Urinary Incontinence
Urinary IncontinenceUrgeUrge urinary incontinence (UUI) is associated with nocturia, a common cause of sleep disorders, also related to levels of anxiety and depression. Studies demonstrate improvement in the clinical parameters of women with UUI after treatment with transcutaneous tibial nerve stimulation (TTNS). However, there are few data available on the association of urinary symptoms in women with UUI with sedentary behavior (SB), physical activity level (PAL) and sleep quality (SQ). Our study has the objective of evaluating the impact of TTNS on urinary symptoms, anxiety level, life quality(LQ), sleep parameters, PAL and SB in women with UUI.
Intradetrusor Botulinum Toxin A: Are Less Injections Better?
Overactive BladderUrinary Urge Incontinence6 morePatients with either overactive bladder (OAB) or urgency urinary incontinence (UUI) with be randomized (like a flip of a coin) to receive 100 units of bladder Botox® at either one injection site or ten injection sites. Efficacy and patient satisfaction will be measured by questionnaires.
Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge...
Overactive Bladder SyndromeUrinary Incontinence1 moreThis study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence
Urinary Stress Incontinence and Urgency in Women With EMSELLA
Stress Urinary IncontinenceUrge IncontinenceThe purpose of this prospective study is to examine the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for the treatment of women with stress urinary incontinence (SUI), urge incontinence (UI) and mixed stress urinary and urge incontinence (MUI), looking at any potential sexual health benefits that may be concomitantly achieved from this treatment.
Repetitive Transcranial Magnetic Stimulation in Women With Overactive Bladder With Urgency Incontinence...
Overactive BladderUrge IncontinenceOveractive bladder (OAB) affects an estimated 16-30% of women in the US and urgency urinary incontinence (UUI) affects 7-11% of women with OAB. It is known that repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) can modulate the pelvic floor muscle activity with potential benefits for various urologic conditions. The goal of this study is to assess feasibility of rTMS as a treatment option for OAB with UUI by determining which rTMS frequency is most effective in targeting sensory components of OAB, namely urinary urgency, and also in targeting the brain network known to be involved in OAB.
TReating Incontinence for Underlying Mental and Physical Health
Urinary IncontinenceUrge7 moreThe TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed to compare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonist bladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinary incontinence and either normal or mildly impaired cognitive function at baseline.