About this trial
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
Qualifiers
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.
Disqualifiers
Pregnant or planning pregnancy during the study period.
Bleeding disorders.
Severe needle phobia.
Presence of a pacemaker.
Trial design
Treatments tested in this trial
- Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy
- Neuromodulation therapy
- Sham Acupuncture
Treatment groups
Sponsors and collaborators
Chelsea and Westminster NHS Foundation Trust
Lead sponsor
Imperial College London
Collaborator