Changeflow GovPing Healthcare & Life Sciences Effectiveness of Ambulatory Transcutaneous Tibi...
Routine Notice Added Final

Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

Favicon for changeflow.com ClinicalTrials.gov Studies
Published
Detected
Email

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.

Published by NIH on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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.

Archived snapshot

Apr 21, 2026

GovPing 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.

← ClinicalTrials.gov Studies

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

View original document →

Get daily alerts for ClinicalTrials.gov Studies

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from NIH.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Clinical trial registration Neuromodulation study
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Medical Devices Healthcare

Get alerts for this source

We'll email you when ClinicalTrials.gov Studies publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!