Electroacupuncture as a Treatment for Refractory Overactive Bladder (EAOAB)

Electroacupuncture as a Treatment for Refractory Overactive Bladder: A Feasibility /Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nocturia; Over Active Bladder; Urinary Incontinence (UI)
• Intervention / Treatment: Device: Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy; Device: Neuromodulation therapy; Device: Sham Acupuncture

Detailed Description

Overactive bladder (OAB) is a common and distressing condition characterised by urinary urgency, frequency, nocturia, and, in some cases, urgency urinary incontinence. OAB can substantially affect quality of life, psychological wellbeing, social participation, and healthcare utilisation. Although first-line management includes behavioural interventions and pelvic floor physiotherapy, a proportion of women continue to experience bothersome symptoms despite these treatments and require additional therapeutic options.

Electroacupuncture (EA) has emerged as a potential treatment for lower urinary tract symptoms and overactive bladder. Previous studies suggest that EA may improve urinary symptoms through neuromodulatory mechanisms; however, the quality, consistency, and applicability of the evidence remain uncertain. Percutaneous tibial nerve stimulation (PTNS) is an established neuromodulation treatment used within clinical practice and is recommended for selected patients with refractory OAB. To date, there is limited evidence directly comparing EA with PTNS, and uncertainty remains regarding the feasibility of conducting a definitive comparative trial.

The purpose of this study is to evaluate the feasibility and acceptability of a three-arm randomised controlled trial comparing electroacupuncture, PTNS, and sham electroacupuncture in women with refractory OAB.

This is a single-centre feasibility randomised controlled trial conducted within a pelvic health physiotherapy service. Thirty-six women with refractory OAB will be randomised in a 1:1:1 ratio to receive:

1. Electroacupuncture (EA)
2. Percutaneous tibial nerve stimulation (PTNS)
3. Sham electroacupuncture

Participants will receive weekly treatment sessions for 12 weeks and will be followed up at baseline, 6 weeks, 12 weeks, 6 months, and 12 months.

The primary outcomes are feasibility outcomes, including:

• Recruitment rate
• Consent rate
• Retention rate
• Treatment adherence
• Data completeness
• Intervention delivery and fidelity
• Blinding credibility
• Safety and adverse events
• Participant acceptability

Exploratory clinical outcomes include:

• International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
• International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

The study is not powered to detect treatment effectiveness. Findings will be used to estimate key feasibility parameters and inform the design, conduct, and sample size calculation of a future definitive randomised controlled trial.

The study has received favourable ethical approval from a UK Research Ethics Committee and NHS Research & Development approval. The study is sponsored by Chelsea and Westminster Hospital NHS Foundation Trust and forms part of a PhD programme at Imperial College London.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elmas Court; Phone Number: +447538355975; Email: elmas.court@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital NHS Foundation Trust
    • Contact: Elmas Court, BSc (hons) Physiotherapy; Phone Number: +447538355975; Email: elmas.court@nhs.net
    • Contact: Rufus Mr. Cartwright; Phone Number: +447720544811; Email: rufus.cartwright@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Electroacupuncture (EA) Group 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; Description: Insertion of acupuncture needles at specific points with electrical stimulation (2 Hz) for 30 minutes per session.
Active Comparator: Arm 2: Percutaneous Tibial Nerve Stimulation (PTNS) Group; 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; 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.; Other Names: Percutaneous Tibial Nerve Stimulation (PTNS)
Sham Comparator: Arm 3: Sham Acupuncture (Control) Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From beginning of trial to 12 months after the trial
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.	From randomisation to 12 weeks after randomisation
Participant Satisfaction and Treatment Acceptability	Participants will complete a study-specific Likert-scale questionnaire at 12 weeks to assess satisfaction, perceived benefit, treatment burden, and overall acceptability of the intervention. The questionnaire will explore participants' experiences of treatment, including ease of participation, perceived symptom improvement, and willingness to recommend the intervention to others. Results will be used to evaluate the acceptability and feasibility of the interventions and trial procedures.	This questionnaire will be completed at 12 weeks (end of treatment)

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust
• Collaborators: Imperial College London
• Investigators: 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 Director: 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; Principal Investigator: Elmas X Court, Chelsea and Westminster Hospital and Imperial College London; Study Chair: Leila Janani, PhD, Imperial College London-Advanced Research Fellow / Senior Clinical Trials Statistician Deputy Head of Trial Methodology

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: July 31, 2025
• First Submitted That Met QC Criteria: August 8, 2025
• First Posted (Actual): August 15, 2025

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 13, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Neuromodulation; Acupuncture; PTNS; Electric-Acupuncture
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Nocturia; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: OAB; IRAS No: 354646 (Other Identifier: Health Research Authority (HRA), United Kingdom); REC reference: 26/LO/0362 (Other Identifier: London - Chelsea Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided: It is not yet known if there will be a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No