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Electroacupuncture as a Treatment for Refractory Overactive Bladder: A Feasibility /Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
United Kingdom
Chelsea and Westminster hospital NHS foundation Trust
RECRUITING
London
Contact Information
Primary
Elmas Court
elmas.court@nhs.net
+447538355975
Time Frame
Start Date: 2026-08-15
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 24
Treatments
Experimental: Arm 1: Electroacupuncture (EA) Group 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:
Active_comparator: Arm 2: Percutaneous Tibial Nerve Stimulation (PTNS) Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Imperial College London
Leads: Chelsea and Westminster NHS Foundation Trust

This content was sourced from clinicaltrials.gov