Comparing Botox injections to combined medication for overactive bladder
Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
PHASE4 · Mackay Memorial Hospital · NCT05968885
This study is testing whether Botox injections or a mix of two medications can help people with overactive bladder who haven't found relief from other treatments.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | Female |
| Sponsor | Mackay Memorial Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05968885 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of botulinum toxin type A bladder injections compared to a combination of Mirabegron and Solifenacin in patients with detrusor overactivity who have not responded to single-drug treatments. Participants will be divided into two groups, receiving either the Botox injection or the combined pharmacotherapy. The study will assess both subjective symptoms related to incontinence and objective measures such as urinary urgency and bladder capacity. Evaluations will be conducted using standardized questionnaires and urodynamic assessments.
Who should consider this trial
Good fit: Ideal candidates are patients with detrusor overactivity who have not found relief from monotherapy with anti-muscarinics or β3-adrenoceptor agonists.
Not a fit: Patients with postvoid urine retention prior to treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from refractory overactive bladder.
How similar studies have performed: Other studies have shown promising results with botulinum toxin for overactive bladder, indicating that this approach has been tested and may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study Exclusion Criteria: * Postvoid urine retention before treatment
Where this trial is running
Taipei
- Mackay Memorial Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Hui-Hsuan Lau, MD — Mackay Memorial Hospital
- Study coordinator: Hui-Hsuan Lau, MD
- Email: huihsuan1220@gmail.com
- Phone: +886-2-25433535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Bladder, Overactive, Urodynamics, Effect of Drug, Detrusor overactivity, Urodynamic study, Combined pharmacotherapy, Botulinum Toxins, Effectiveness