Electroacupuncture as a Treatment for Refractory Overactive Bladder

NCT07124390 | Recruiting DMC

• 3 other identifiers: OABIRAS No: 354646REC reference: 26/LO/0362
• Study Type: interventional
• Target: 24
• 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), and percutaneous tibial nerve stimulation (PTNS), 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, safety, and participant acceptability. Twenty-four participants will be randomly allocated to receive electroacupuncture or PTNS, 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 (5)

• Frequency and Severity of Adverse Events

  All adverse events related to EA or PTNS will be recorded and categorised by severity and causality. Monitoring will follow ICH Good Clinical Practice (E6\[R2\]) standards to ensure participant safety.

  Baseline, during each treatment session, 6 weeks, 12 weeks, and throughout study participation up to 12 weeks after randomisation.

• Recruitment Rate

  Recruitment feasibility will be assessed as the number and proportion of eligible patients who consent to participate in the study. The number of patients approached, assessed for eligibility, eligible, and recruited will be recorded. Reasons for declining participation will also be recorded where available.

  At completion of recruitment (anticipated recruitment period: Sept 2026 to March 2027.

• Participant Retention and Follow-up Completion Rate.

  Retention will be assessed as the number and proportion of randomised participants who remain in the study and complete the scheduled follow-up assessments. Participant withdrawals and losses to follow-up will be recorded, including reasons where available.

  6 weeks, 12 weeks, 6 months, and 12 months after randomisation.

• Treatment Compliance and Attendance Rates

  Participant adherence will be tracked through a treatment log. Missed sessions and reasons for non-attendance will be recorded to assess treatment feasibility and refine delivery strategies for future implementation.

  During each treatment session and at 12 weeks after randomisation.

• Outcome Data Completeness

  Feasibility of outcome data collection will be assessed as the number and proportion of participants providing complete outcome measure data at each scheduled assessment. Missing questionnaires, questionnaire items, bladder diary data and other missing outcome data will be recorded.

  Baseline, 6 weeks, 12 weeks, 6 months and 12 months

Secondary Outcomes (4)

• Participant Satisfaction and Treatment Acceptability

  At the end of 12 weeks post treatment

• Change in Overactive Bladder Symptoms Measured by ICIQ-OAB

  Baseline, 6 weeks, 12 weeks, 6 months and 12 months

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

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

• Change in Overactive Bladder Symptoms Measured Using a 3-Day Bladder Diary

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

Study Arms (2)

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

Interventions

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

Description: Insertion of acupuncture needles at specific points with electrical stimulation (20 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

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, United Kingdom, SW10 9NH, United Kingdom

RECRUITING

Related Links

• not available at present

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pelvic Health Physiotherapist

Model Details: 2 arm parallel Pilot-RCT

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 15, 2025
• Study Start: August 15, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

GB (1)