About this trial
This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke.
Primary Hypothesis: PTNS therapy will significantly improve OAB symptoms in post-stroke patients compared to standard care/sham stimulation.
Primary Outcome Measure: Change from baseline in Overactive Bladder Symptom Score (OABSS) and/or frequency of urgency episodes as assessed after 12 weeks of treatment."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Age 40 to 70 years
History of ischemic or hemorrhagic stroke at least 6 months before enrollment
Presence of overactive bladder symptoms
Disqualifiers
Age outside the study range
Pregnancy or breastfeeding
Active urinary tract infection
Neurogenic conditions other than stroke affecting bladder function
Trial design
Parallel
Treatments tested in this trial
posterior tibial nerve stimulation, PTNS
Deviceposterior tibial nerve stimulation, PTNS
Treatment groups
Trial outcomes
Primary outcomes
Change in daily frequency of urgency episodes
Number of urgency episodes per 24 hours recorded in patient bladder diary.
Secondary outcomes
Change in micturition frequency
Average number of micturitions per 24 hours.
Sponsors and contacts
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