Over Active BladderEAOABNCT07124390
Electroacupuncture as a Treatment for Refractory Overactive Bladder
A study testing Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy and Neuromodulation therapy in people with Over Active Bladder and Urinary Incontinence (UI), run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Over Active Bladder, Urinary Incontinence (UI), Nocturia
- What is being tested?
- Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy and Neuromodulation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2026to 30 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster hospital NHS foundation Trust
London, United Kingdom, SW10 9NH
Elmas Court, BSc (hons) Physiotherapy, +447538355975, elmas.court@nhs.net
Rufus Mr. Cartwright, +447720544811, rufus.cartwright@nhs.net
About this study
Official title: 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), 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.
Read more
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.
Read the 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 two-arm randomised controlled trial comparing electroacupuncture and PTNS in women with refractory OAB.
This is a single-centre feasibility randomised controlled trial conducted within a pelvic health physiotherapy service. Twent-four women with refractory OAB will be randomised in a 1:1 ratio to receive:
- Electroacupuncture (EA)
- Percutaneous tibial nerve stimulation (PTNS)
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
- Safety and adverse events
- Participant acceptability
Exploratory clinical outcomes include:
- International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-OAB)
- International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) International Consultation on Incontinence Questionnaire 3 day bladder diary (ICIQ BD) Short health economics questioner
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.
- Conditions
- Over Active Bladder, Urinary Incontinence (UI), Nocturia
- Being tested
- Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy, Neuromodulation therapy
- Keywords
- Electric-Acupuncture, Acupuncture, PTNS, Neuromodulation
- Medical subject headings
- Urinary Incontinence, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Name: Electroacupuncture (EA) Type: Device-based acupuncture therapyDevice
Description: Insertion of acupuncture needles at specific points with electrical stimulation (20 Hz) for 30 minutes per session.
Neuromodulation therapyDevice
Also called Percutaneous Tibial Nerve Stimulation (PTNS)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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: Receives: 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. Receives: Device: Neuromodulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks, 12 weeks, 6 months and 12 months
Secondary outcomes (4)
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.
Measured: At the end of 12 weeks post treatment
Change in Overactive Bladder Symptoms Measured by ICIQ-OAB
change in overactive bladder symptoms as assessed by the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB). The questionnaire evaluates urinary frequency, urgency, nocturia, and urge urinary incontinence. Changes in total and individual symptom scores from baseline to the end of treatment will be compared between study groups, with lower scores indicating an improvement in symptom severity.
Measured: Baseline, 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.
Measured: 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
Participants will complete a 3-day bladder diary at baseline, 6 weeks, 12 weeks, 6 months and 12 months. Diary measures will include daytime urinary frequency, nocturia, urgency episodes, urgency urinary incontinence episodes, voided volume, fluid intake and pad use. Changes in bladder diary outcomes over time will be explored within and between the treatment groups.
Measured: This questionnaire will be completed at Baseline, 6 weeks, 12 weeks, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start15 Aug 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over Active BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm parallel Pilot-RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Principal investigator, Elmas, Chelsea and Westminster NHS Foundation Trust
- Investigators
- Leila Janani, PhD, Study chair, Imperial College London-Advanced Research Fellow / Senior Clinical Trials Statistician Deputy Head of Trial MethodologyDeepa Dr Abichandani, Study chair, Senior Lecturer in Physiotherapy Employability Lead for School of Allied and Community Health London South Bank UniversitMark Pro. Johnson, Study chair, 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 anRufus Mr. Cartwright, Study director, Uro-gynaecologist consultant and Honorary Clinical Senior Lecturer institute of Reproductive and Developmental Biology, Hammersmith Campus and Celsea and Westminster NHS Trust Gynaecology and DepartmElmas X Court, Principal investigator, Chelsea and Westminster Hospital and Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124390
- Sponsor's protocol ID
- OAB
- Other IDs
- IRAS No: 354646, REC reference: 26/LO/0362
- Acronym
- EAOAB
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided: It is not yet known if there will be a plan to make IPD available