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Electroacupuncture as a Treatment for Refractory Overactive Bladder

Sponsor: Chelsea and Westminster NHS Foundation Trust • ClinicalTrials.gov ID: NCT07124390

Registry updated: 2026-08-28

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Description

This study is a single-site feasibility randomised controlled trial evaluating the feasibility and acceptability of electroacupuncture (EA), and percutaneous tibial nerve stimulation (PTNS), in women with refractory overactive bladder (OAB) who have not achieved satisfactory improvement following standard pelvic health physiotherapy. The primary aim is to determine whether a larger definitive trial is feasible by assessing recruitment, consent, retention, treatment adherence, data completeness, intervention delivery, safety, and participant acceptability. Twenty-four participants will be randomly allocated to receive electroacupuncture or PTNS, over a 12-week treatment period. Outcome assessments will be completed at baseline, 6 weeks, 12 weeks, 6 months, and 12 months. The findings will inform the design of a future definitive randomised controlled trial and contribute to the evidence base for non-pharmacological treatment options for overactive bladder.

Interventions

Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy (Device)
Description: Insertion of acupuncture needles at specific points with electrical stimulation (20 Hz) for 30 minutes per session.
Neuromodulation therapy (Device)
Type: Neuromodulation therapy Description: Insertion of a needle electrode near the medial malleolus with low-voltage electrical stimulation (20 Hz) applied for 30 minutes per session.

Eligibility criteria

Inclusion Criteria: Participants must meet all of the following criteria: * Female adults aged 18 years or older. * Diagnosed with overactive bladder syndrome (ICIQ-OAB score ≥10). * Symptoms present for at least three months and refractory to first-line treatments. * Willing to refrain from starting new bladder-related treatments during the study period. * Able and willing to provide written informed consent. Exclusion Criteria: * Participants meeting any of the following criteria will be excluded: * Pregnant or planning pregnancy during the study period. * Bleeding disorders. * Severe needle phobia. * Presence of a pacemaker. * Active cancer diagnosis. * Active urinary tract infections or other urological conditions requiring urgent intervention. * Participation in another clinical trial for bladder dysfunction within the past six months. * Neurological conditions affecting continence (e.g., diabetic neuropathy, multiple sclerosis, Parkinson's disease). * Life-threatening infections. * Severe cognitive deficits, unconsciousness, dementia (e.g., Alzheimer's or other neurodegenerative diseases). * History of incontinence surgery. * Previous acupuncture for OAB within the past two months. * History of thromboses. * Recovering from or suffering from a serious illness or major surgery.

Conditions

Over Active Bladder Urinary Incontinence (UI) Nocturia

Locations

Chelsea and Westminster hospital NHS foundation Trust — London, United Kingdom, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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