Overactive Bladder
Conditions
Interventions
A washout period of 2 weeks will be scheduled before the clinical trial. Participants take tramadol (25-100 mg/ day bid, depending on adverse event) for 24 weeks. A 5 Hz frequency, 0.05 ms pulse width
Sponsors
Department of Urology, Faculty of Medical Sciences, University of Fukui
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with overactive bladder who are 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 comorbidities 3. Able to understand the nature of study and give written informed consent 4. 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 metallic implants inside the stimulation locus 3. Patients with severe heart or lung 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 stimulation locus 6. Pregnant women 7. Patients with history of convulsion or patients seizures are predicted 8. Patients with excessive post-void residual volume (100 ml or 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
| Measure | Time frame |
|---|---|
| Improvements in following questionnaires will be assessed at 12- and 24-week; 1. International Prostate Symptom Score and QOL index 2. Overactive Bladder Symptom Score 3. International Index of Erectile Dysfunction in male subjects/Female Sexual Function Index in female subjects 4. King's Health Questionnaire, Japanese edition | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of following examinations will be carried out at 12- and 24-week; 1) Frequency-volume chart 1. voiding frequency, voiding volume, nocturnal polyuria index (NPi) 2) Urodynamic study parameters 1. Uroflowmetry parameters, post-void residulal volume 2. Cystometric parameters | — |
Countries
Japan
Contacts
Public ContactYosuke Matsuta
University of Fukui Department of Urology
Outcome results
None listed