An interventional study of Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy and Neuromodulation therapy in Over Active Bladder, Urinary Incontinence (UI) and Nocturia, sponsored by Chelsea and Westminster NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Chelsea and Westminster NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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:
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:
Exploratory clinical outcomes include:
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 24 is below the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
Description: Insertion of acupuncture needles at specific points with electrical stimulation (20 Hz) for 30 minutes per session.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks, 12 weeks, 6 months and 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This questionnaire will be completed at Baseline, 6 weeks, 12 weeks, 6 months, and 12 months
Plan to share: Undecided — Undecided: It is not yet known if there will be a plan to make IPD available
Started Aug 2026 (actual). Primary completion is estimated for Nov 2027, 15 months after the start.
Of 301 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 15 months is close to that.
Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chelsea and Westminster NHS Foundation Trust