Efficacy of Transcutaneous Electrical Stimulation Therapy in the Treatment of Overactive Bladder Developing After Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-70
SponsorKutahya Health Sciences University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • posterior tibial nerve stimulation, PTNS

    Device

    posterior tibial nerve stimulation, PTNS

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: posterior tibial nerve stimulation, PTNSExperimental treatment 1 intervention
Group B: standart treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in daily frequency of urgency episodes

Number of urgency episodes per 24 hours recorded in patient bladder diary.

Time frame
Baseline and at 12 weeks.

Secondary outcomes

1

Change in micturition frequency

Average number of micturitions per 24 hours.

Time frame
Baseline and at 12 weeks.

Other outcomes

Sponsors and contacts

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