Electroacupuncture as a Treatment for Refractory Overactive Bladder

NCT07124390 | Not Yet Recruiting DMC

• 3 other identifiers: OABIRAS No: 354646REC reference: 26/LO/0362
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Electric-Acupuncture; Acupuncture; PTNS; Neuromodulation

Outcome Measures

Primary Outcomes (2)

• Change in Female Lower Urinary Tract Symptoms Measured by ICIQ-FLUTS

  Participants will complete the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) at baseline, 6 weeks, 12 weeks, 6 months, and 12 months. The questionnaire assesses the severity and impact of female lower urinary tract symptoms, including urinary urgency, frequency, nocturia, and urinary incontinence. Changes in questionnaire scores over time will be explored to assess symptom progression and response to treatment.

  This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months

• Change in Urinary Symptom-Related Quality of Life Measured by ICIQ-LUTSqol

  Participants will complete the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) questionnaire at baseline, 6 weeks, 12 weeks, 6 months, and 12 months. The questionnaire assesses the impact of lower urinary tract symptoms on quality of life, including physical, social, emotional, and daily activities. Changes in questionnaire scores over time will be explored to assess the impact of treatment on symptom-related quality of life.

  This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months

Secondary Outcomes (3)

• Participant Satisfaction and Treatment Acceptability

  This questionnaire will be completed at 12 weeks (end of treatment)

• Frequency and Severity of Adverse Events

  From beginning of trial to 12 months after the trial

• Treatment Compliance and Attendance Rates

  From randomisation to 12 weeks after randomisation

Study Arms (3)

Arm 1: Electroacupuncture (EA) Group Experimental

EXPERIMENTAL

Arm 1: Electroacupuncture (EA) Group Arm Type: Experimental Description: Participants in this group will receive electroacupuncture treatment targeting sacral and lower abdominal acupuncture points traditionally used for overactive bladder (OAB). Sterile, single-use acupuncture needles will be inserted and connected to an electroacupuncture device that delivers a low-frequency electrical current. Duration: 12 weekly sessions over 12 weeks Setting: Delivered by trained pelvic health physiotherapists in an outpatient hospital setting. Intervention:

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

Arm 2: Percutaneous Tibial Nerve Stimulation (PTNS) Group

ACTIVE COMPARATOR

Arm Type: Active Comparator Description: Participants in this group will receive percutaneous tibial nerve stimulation, a standard treatment for OAB. A fine needle electrode is inserted near the ankle to stimulate the tibial nerve, transmitting signals to the sacral nerve plexus that controls bladder function. Duration: 12 weekly sessions over 12 weeks Setting: Delivered by trained clinicians in an outpatient setting.

Device: Neuromodulation therapy

Arm 3: Sham Acupuncture (Control) Group

SHAM COMPARATOR

Description: Needles will be placed superficially (2-3 mm depth) at non-acupuncture points located approximately 1-2 cm lateral to the true sacral and abdominal treatment points, avoiding recognised meridian locations. Electrical Stimulation Electrode clips will be attached to needles, and the electroacupuncture device will be activated without delivering electrical output (no current transmission). Visual and auditory cues will be maintained to preserve credibility. This is used as a control to assess the true efficacy of EA compared to placebo. Duration: 12 weekly sessions over 12 weeks Setting: Delivered by trained physiotherapists using standardised placebo protocols.

Device: Sham Acupuncture

Interventions

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

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

Arm 1: Electroacupuncture (EA) Group Experimental

Neuromodulation therapy DEVICE

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.

Also known as: Percutaneous Tibial Nerve Stimulation (PTNS)

Arm 2: Percutaneous Tibial Nerve Stimulation (PTNS) Group

Sham Acupuncture DEVICE

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.

Arm 3: Sham Acupuncture (Control) Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified genders eligible to participate: Women (Cisgender women)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• Imperial College London: collaborator

Study Sites (1)

Chelsea and Westminster hospital NHS foundation Trust

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence; Nocturia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Leila Janani, PhD

  Imperial College London-Advanced Research Fellow / Senior Clinical Trials Statistician Deputy Head of Trial Methodology

  STUDY CHAIR

• Deepa Dr Abichandani

  Senior Lecturer in Physiotherapy Employability Lead for School of Allied and Community Health London South Bank Universit

  STUDY CHAIR

• 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

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Elmas X Court

  Chelsea and Westminster Hospital and Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elmas Court

CONTACT

+447538355975; elmas.court@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants allocated to the electroacupuncture and sham electroacupuncture groups will be blinded to treatment allocation. Due to the nature of the interventions, treatment providers cannot be blinded. Blinding credibility will be assessed at the end of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pelvic Health Physiotherapist

Model Details: 3 arm parallel RCT

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 15, 2025
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

GB (1)