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NCT07124390
Electroacupuncture as a Treatment for Refractory Overactive Bladder
Conditions: Over Active Bladder, Urinary Incontinence (UI), Nocturia
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: Chelsea and Westminster NHS Foundation Trust
Location: Chelsea and Westminster hospital NHS foundation Trust London
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.
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.
Source: ClinicalTrials.gov (NCT07124390). StuddyBuddy aggregates publicly available trial information.