Electroacupuncture as a Treatment for Refractory Overactive Bladder

NCT07124390 | Not Yet Recruiting DMC

• 2 other identifiers: OABIRAS No: 1011199
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Electric-Acupuncture; Acupuncture; PTNS; Neuromodulation

Outcome Measures

Primary Outcomes (3)

• Improvement in Overactive Bladder Symptoms Using the International Consultation on Incontinence Questionnaire - Overactive Bladder Module (ICIQ-OAB)

  Participants will complete the validated International Consultation on Incontinence Questionnaire - Overactive Bladder (ICIQ-OAB) at baseline, 6 weeks, 12 weeks, 6 months, and 12 months to assess changes in urinary symptoms, including urgency, frequency, nocturia (waking up to urinate), and incontinence. The ICIQ-OAB is a standardised, reliable, and responsive patient-reported outcome measure commonly used to monitor the severity and impact of overactive bladder symptoms. It consists of four symptom-specific questions, each scored from 0 to 4 or 0 to 5, resulting in a total score range from 0 to 16, where higher scores indicate more severe symptoms. A decrease in total score over time will indicate an improvement in OAB symptoms. The measure is sensitive to change, making it appropriate for tracking the effectiveness of interventions over multiple time points.

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

• Change in Urinary Frequency and Incontinence Episodes via 3-Day Bladder Diary

  Participants will complete a bladder diary for 3 consecutive days at baseline, 6 weeks, 12 weeks, 6 months, and 12 months. This diary captures frequency of voids, incontinence episodes, urgency, and fluid intake. Bladder diaries are a gold standard for tracking urinary behaviour and treatment response in OAB management. Less visit to toilet will show positive outcome

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

• Change in Functional Activity Measured by Patient-Specific Functional Scale (PSFS)

  Participants will identify up to three daily activities affected by overactive bladder (OAB) and rate their ability to perform each activity on a scale from 0 to 10, using the Patient-Specific Functional Scale (PSFS). A score of 0 indicates they are unable to perform the activity at all, while a score of 10 reflects their prior or normal level of function before symptoms began. The PSFS is a patient-centred, valid, and responsive measure that allows individuals to report the specific functional limitations that matter most to them. This personalised approach ensures relevance and sensitivity to change, as it captures the real-life impact of OAB on daily functioning. An increase in scores over time will indicate an improvement in function and reduced symptom interference, while stable or declining scores may suggest limited benefit or worsening symptoms. This tool complements symptom-based questionnaires by focusing on individual goals and quality of life.

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

Secondary Outcomes (7)

• The International Consultation on Incontinence Questionnaire - Overactive Bladder Quality of Life (ICIQ-OABqol) will be used to assess the impact of overactive bladder (OAB) symptoms on participants' quality of life.

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

• Pain Intensity Measured by Visual Analogue Scale (VAS)

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

• Patient Satisfaction Assessed by Likert-Scale Questionnaire

  This questionnaire will be completed at 12 weeks

• Incremental Cost-Effectiveness Ratio (ICER) of EA vs. PTNS

  This questionnaire will be completed at 12 months

• Frequency and Severity of Adverse Events

  From beginning of trial to 12 months after the trial

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: Participants in this group will receive non-penetrating sham acupuncture using blunt-tipped placebo needles that mimic the look and feel of real acupuncture but do not penetrate the skin or provide electrical stimulation. 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, United Kingdom, SW10 9NH, United Kingdom

Location

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

• Lesley Professor Regan

  Obstetrics and Gynaecology and Consultant in Gynaecology at the Imperial College and Consultant at NHS Trust St Mary's Hospital Campus

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: PI will be blinded to randomisation and data collection
• 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: February 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-07

Locations

GB (1)