Electroacupuncture as a Treatment for Refractory Overactive Bladder

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.

Conditions

• Over Active Bladder
• Urinary Incontinence (UI)
• Nocturia

Interventions

DEVICE

Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy

Description: Insertion of acupuncture needles at specific points with electrical stimulation (2 Hz) for 30 minutes per session.

DEVICE

Neuromodulation therapy

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.

DEVICE

Sham Acupuncture

Type: Placebo Description: Non-invasive, non-penetrating placebo needles placed at the same points as in the EA group, without electrical stimulation, for 30 minutes per session.

Sponsors & Collaborators

• Imperial College London

  collaborator OTHER

• Chelsea and Westminster NHS Foundation Trust

  lead OTHER

Principal Investigators

• Leila Janani, PhD · Imperial College London-Advanced Research Fellow / Senior Clinical Trials Statistician Deputy Head of Trial Methodology

• Deepa Dr Abichandani · Senior Lecturer in Physiotherapy Employability Lead for School of Allied and Community Health London South Bank Universit

• Mark Pro. Johnson · Senior Lecturer, Consultant in Obstetrics and Obstetric Medicine Charing Cross Hospital. And Chelsea and Westminster NHS Trust Imperial College London Clinical Chair in Obstetrics Department of Metabolism, Digestion an

• Rufus Mr. Cartwright · Uro-gynaecologist consultant and Honorary Clinical Senior Lecturer institute of Reproductive and Developmental Biology, Hammersmith Campus and Celsea and Westminster NHS Trust Gynaecology and Departm

• Elmas X Court · Chelsea and Westminster Hospital and Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2027-07-30

Completion

2027-07-30

Countries

• United Kingdom

Study Locations