Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder
Summary
NIH has registered a randomized clinical trial (NCT07540273) comparing ambulatory versus clinic-based transcutaneous tibial nerve stimulation for treating overactive bladder in adults aged 18-65. The two-arm study will enroll participants receiving identical electrical stimulation parameters (20 Hz, 200 µs) delivered either at home via portable device or in-clinic twice weekly over 2 weeks. The trial will assess urgency episode frequency, bladder symptoms, and quality of life outcomes.
What changed
NIH registered a new randomized clinical trial on ClinicalTrials.gov comparing two modes of delivering transcutaneous tibial nerve stimulation for overactive bladder. The trial will compare a clinic-based protocol (two clinic visits per week for 2 weeks, 30-minute sessions) against an ambulatory protocol (portable home device used during daily routine). Both groups receive identical stimulation parameters. The study will measure urgency episodes, voiding frequency, and quality of life at baseline and follow-up.
Healthcare providers and device manufacturers involved in neuromodulation research may find this trial relevant for understanding emerging home-based stimulation protocols. The trial is registered and not subject to compliance obligations under this posting.
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Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder
N/A NCT07540273 Kind: NA Apr 20, 2026
Abstract
The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. The main questions it aims to answer are:
- Does using TENS at home during daily activities reduce the number of urgency episodes?
- Does this approach improve bladder symptoms and quality of life as much as clinic-based treatment?
Researchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation):
- Group 1 (Clinic-based): Participants will visit the clinic twice a week for 2 weeks and receive 30-minute TENS sessions.
- Group 2 (Ambulatory): Participants will use a portable TENS device at home during their daily routine when they feel the urge to urinate, over a 2 week period.
Both groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width).
Participants will:
- Complete bladder symptom questionnaires before and after the study
- Fill in a 3-day voiding diary to track how often they urinate, urgency episodes, and any leakage
- Answer quality of life questions at the start and at 4 weeks
Conditions: Overactive Bladder (OAB), Urinary Urgency
Interventions: Ambulatory Transcutaneous Tibial Nerve Stimulation, Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation
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