Can nerve stimulation beat education for overactive bladder?
NCT ID NCT07744620
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial tests three 8-week approaches for women with overactive bladder: standard education on pelvic floor exercises, biofeedback-assisted training, and biofeedback combined with tibial nerve stimulation. The goal is to see if adding biofeedback or nerve stimulation provides better relief from symptoms like urgency and frequent urination. Participants are randomly assigned to one of the three groups and track their exercises at home. The study also looks at whether women with different symptom patterns respond differently to each treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Behavioral therapy and neuromodulation: verbal education, biofeedback-assisted pelvic floor muscle training, and tibial nerve stimulation
- What this could lead to
- If successful, this could identify the most effective non-drug treatment for overactive bladder, potentially reducing symptoms like urgency and frequent urination without medication.
- What could go wrong
- The trial is relatively small and early, and results may not apply to all women with overactive bladder. Some participants may not respond to the treatments, and the added benefit of biofeedback or nerve stimulation over education alone is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 201 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Stable on chronic medications: Participants must have been on a long-term, regular regimen of routine medications for chronic conditions (e.g., hypertension, diabetes, hyperlipidemia) prior to study entry, with no expected changes in dosage or administration during the 8-week study period. * Diagnosed with Overactive Bladder (OAB) according to the International Continence Society (ICS) definition, including urgency, frequency, and nocturia, with or without urgency urinary incontinence (must be documented as OAB-wet or OAB-dry). * Symptoms persisting for at least 3 months. * Overactive Bladder Symptom Score (OABSS) total score ≥ 3 at baseline (Week 0), with an urgency score (Question 3) ≥ 2 (meeting the clinical threshold for core OAB symptom intensity). Exclusion Criteria: * Concurrent active urinary tract infection (UTI), bladder stones, or urinary tract malignancy. * Inability to follow instructions for muscle training due to cognitive impairment or severe psychiatric illness. * Presence of implanted electronic medical devices (e.g., cardiac pacemakers) (contraindication for electrical stimulation). * Currently pregnant women or those planning to become pregnant during the study period. * Use of antimuscarinics (e.g., Oxybutynin, Tolterodine, Solifenacin) or beta-3 adrenergic receptor agonists (e.g., Mirabegron) within 2 weeks prior to study entry. * Receipt of pelvic or perineal physical therapy outside of this study protocol (e.g., vaginal or anal probe electrical stimulation, pelvic floor magnetic stimulation, transcutaneous microcurrent stimulation) within 2 weeks prior to study entry. * Receipt of intravesical Botulinum toxin (Botox) injections, sacral neuromodulation, or any surgical treatment related to urinary incontinence or pelvic organ prolapse within 2 weeks prior to study entry.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Far Eastern Memorial Hospital
New Taipei City, Taiwan, Taiwan, Taiwan
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