Electroacupuncture as a Treatment for Refractory Overactive Bladder

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
Overactive bladder (OAB) is a common and distressing condition characterised by urinaryurgency, frequency, nocturia, and, in some cases, urgency urinary incontinence. OAB cansubstantially affect quality of life, psychological wellbeing, social participation, andhealthcare utilisation. Although first‐line management includes behavioural interventionsand pelvic floor physiotherapy, a proportion of women continue to experience bothersomesymptoms despite these treatments and require additional therapeutic options.Electroacupuncture (EA) has emerged as a potential treatment for lower urinary tractsymptoms and overactive bladder. Previous studies suggest that EA may improve urinarysymptoms through neuromodulatory mechanisms; however, the quality, consistency, andapplicability of the evidence remain uncertain. Percutaneous tibial nerve stimulation(PTNS) is an established neuromodulation treatment used within clinical practice and isrecommended for selected patients with refractory OAB. To date, there is limited evidencedirectly comparing EA with PTNS, and uncertainty remains regarding the feasibility ofconducting a definitive comparative trial.The purpose of this study is to evaluate the feasibility and acceptability of a three‐armrandomised controlled trial comparing electroacupuncture, PTNS, and shamelectroacupuncture in women with refractory OAB.This is a single‐centre feasibility randomised controlled trial conducted within a pelvichealth physiotherapy service. Thirty‐six women with refractory OAB will be randomised ina 1:1:1 ratio to receive: 1. Electroacupuncture (EA) 2. Percutaneous tibial nerve stimulation (PTNS) 3. Sham electroacupunctureParticipants will receive weekly treatment sessions for 12 weeks and will be followed upat baseline, 6 weeks, 12 weeks, 6 months, and 12 months.The primary outcomes are feasibility outcomes, including: ‐ Recruitment rate ‐ Consent rate ‐ Retention rate ‐ Treatment adherence ‐ Data completeness ‐ Intervention delivery and fidelity ‐ Blinding credibility ‐ Safety and adverse events ‐ Participant acceptabilityExploratory clinical outcomes include: ‐ International Consultation on Incontinence Questionnaire Female Lower Urinary TractSymptoms (ICIQ‐FLUTS) ‐ International Consultation on Incontinence Questionnaire Lower Urinary TractSymptoms Quality of Life (ICIQ‐LUTSqol)The study is not powered to detect treatment effectiveness. Findings will be used toestimate key feasibility parameters and inform the design, conduct, and sample sizecalculation of a future definitive randomised controlled trial.The study has received favourable ethical approval from a UK Research Ethics Committeeand NHS Research & Development approval. The study is sponsored by Chelsea andWestminster Hospital NHS Foundation Trust and forms part of a PhD programme at ImperialCollege London.
Epistemonikos ID: 00f38f9e47a610bebc75e4566140452792d009ef
First added on: Aug 16, 2025