Electroacupuncture as a Treatment for Refractory Overactive Bladder
Trial statusNot yet recruiting
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), 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.
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 (2 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.
Sham Acupuncture
DeviceType: 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.
Treatment groups
32 Participants
are divided into 3 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
Group C: Arm 3: Sham Acupuncture (Control) GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months2
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 6 weeks, 12 weeks, 6 months, and 12 monthsSecondary 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
This questionnaire will be completed at 12 weeks (end of treatment)2
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
From beginning of trial to 12 months after the trial3
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
From randomisation to 12 weeks after randomisationSponsors 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
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