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Not Yet Recruiting
NCT07668063
Device for Bladder Control for Men With SCI
Conditions: Neurogenic Bladder
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 12
Sponsor: VA Office of Research and Development
Location: Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio
Summary
Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Affected individuals typically experience reflex bladder contractions in response to bladder filling at low volumes, resulting in urinary incontinence and decreased bladder capacity. This project will advance a new device for administering noninvasive electrical stimulation in order to improve bladder control.
Eligibility Criteria
Inclusion Criteria:
* Suprasacral SCI
* Neurologically stable
* Skeletally mature
* Presence of reflex bladder contractions
* At least 12 months post SCI
Exclusion Criteria:
* Active sepsis
* Open pressure sores on or around pelvis
* Bleeding diathesis
* Significant urethral trauma, erosion, or stricture
* Indwelling catheter for over 1 year AND bladder capacity less than 100 mL
* Significant history of autonomic dysreflexia
Source: ClinicalTrials.gov (NCT07668063). StuddyBuddy aggregates publicly available trial information.
