Electroacupuncture as a Treatment for Refractory Overactive Bladder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChelsea and Westminster NHS Foundation Trust
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant or planning pregnancy during the study period.
Bleeding disorders.
Severe needle phobia.
Presence of a pacemaker.
Trial design
Design model
Parallel
Treatments tested in this trial
Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy
DeviceDescription: Insertion of acupuncture needles at specific points with electrical stimulation (20 Hz) for 30 minutes per session.
Neuromodulation therapy
DeviceType: 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Electroacupuncture (EA) Group ExperimentalExperimental treatment 1 intervention
Group B: Arm 2: Percutaneous Tibial Nerve Stimulation (PTNS) GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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 2027.3
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.4
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.Secondary outcomes
1
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 treatment2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chelsea and Westminster NHS Foundation Trust
Lead sponsor
Imperial College London
Collaborator
Source ClinicalTrials.gov