Electroacupuncture as a Treatment for Refractory Overactive Bladder

NCT07124390 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-15

No results posted yet for this study

Summary

Brief Summary

The goal of this clinical trial is to learn whether electroacupuncture (EA) is as effective and acceptable as percutaneous tibial nerve stimulation (PTNS) in treating overactive bladder (OAB) in adult women. The main questions it aims to answer are:

Does electroacupuncture reduce OAB symptoms to a similar extent as PTNS? Is electroacupuncture an acceptable and accessible treatment option for women with OAB?

Researchers will compare EA and PTNS with a third group receiving sham acupuncture to see whether EA offers similar or better symptom relief and is more acceptable to participants.

Participants will:

Be randomly assigned to one of three groups: EA, PTNS, or sham acupuncture

Receive one treatment session per week for 12 weeks

Complete symptom diaries, quality-of-life questionnaires, and feedback on treatment acceptability

Attend follow-up assessments after treatment ends

The study will take place at Chelsea and Westminster NHS Foundation Trust, with support from the hospital's Physiotherapy and Urology departments. It is funded by the Chelsea and Westminster Hospital Joint Research Committee (JRC) and Supported by Imperial Collage London.

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

  • Lesley Professor Regan · Obstetrics and Gynaecology and Consultant in Gynaecology at the Imperial College and Consultant at NHS Trust St Mary's Hospital Campus

  • 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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2027-05-20
Completion
2027-06-20

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124390 on ClinicalTrials.gov