Electroacupuncture as a Treatment for Refractory Overactive Bladder (NCT07124390) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Electroacupuncture as a Treatment for Refractory Overactive Bladder
United Kingdom32 participantsStarted 2026-07-01
Plain-language summary
This study is a single-site feasibility randomised controlled trial evaluating the feasibility and acceptability of electroacupuncture (EA), percutaneous tibial nerve stimulation (PTNS), and sham electroacupuncture 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, blinding credibility, safety, and participant acceptability.
Thirty-six participants will be randomly allocated to receive electroacupuncture, PTNS, or sham electroacupuncture 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Female Lower Urinary Tract Symptoms Measured by ICIQ-FLUTS
Timeframe: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months
2
Change in Urinary Symptom-Related Quality of Life Measured by ICIQ-LUTSqol
Timeframe: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months
Trial details
NCT IDNCT07124390
SponsorChelsea and Westminster NHS Foundation Trust