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.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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
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Chelsea and Westminster NHS Foundation Trust