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Development of the home enforceable percutaneous tibial neuromodulation therapy for the refractory overactivity bladder

Development of the home enforceable percutaneous tibial neuromodulation therapy for the refractory overactivity bladder - Development of the home enforceable neuromodulation therapy for the refractory overactivity bladder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011947
Enrollment
20
Registered
2013-10-03
Start date
2013-10-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Interventions

A 5 Hz frequency, 0.2 ms pulse width, biphasic electric stimulation is applied via surface electrodes put on the unilateral sole or internal malleolus. An 30-minute-stimulation is given once a day con

Sponsors

Department of Urology, Faculty of Medical Sciences, University of Fukui
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with overactive bladder resistant to the standard therapies (behavior therapy, antimuscarinics, beta3 receptor agonist, etc.) 2. Patients with overactive bladder having difficulty with continuation of medical therapy because of side effects or co-morbidities 3. Patients who are able to understand the nature of study and give written informed consent 4. Patients who have willingness and ability to comply with the study protocol for the duration of the study

Exclusion criteria

Exclusion criteria: 1. Patients with cardiac pacemakers 2. Patients with severe arrhythmia (AV block, etc.) 3. Patients with severe heart disease 4. Patients with venous/arterial thrombosis or thrombophlebitis of lower extremities 5. Patients with skin disorder (injury, scar, skin disease, malignancy, etc.) on the lower extremities 6. Pregnant women 7. Patients with history of convulsion or patients seizures are predicted 8. Patients with excessive post-void residual volume (100 ml and more) 9. Patients with bladder disorders (calculus, cancer, tuberculosis, chronic bacterial cystitis, radiation cystitis, etc.) 10. Any condition which in the judgment of the investigator would place the patient inappropriate to be enrolled in this study

Design outcomes

Primary

MeasureTime frame
1) Assess the improvement in the following questionnaire 1. International Prostate Symptom Score and QOL index 2. Overactive Bladder Symptom Score 3. Core lower urinary tract symptom score 4. King's Health Questionnaire, Japanese edition 2) Assess the improvement in the frequency-volume chart voiding frequency, voiding volume, nocturnal polyuria index (NPi) 3) Assess the improvement in the urodynamic study parameters 1. uroflowmetry parameters, post-void residual volume 2. cystometric parameters

Countries

Japan

Contacts

Public ContactYosuke Matsuta

University of Fukui Department of Urology

ymatsuda@u-fukui.ac.jp0776-61-8399

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026