Comparing two treatments for women with overactive bladder
Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity
This study tests whether a combination of two medications or a medication with vaginal estrogen cream helps women with overactive bladder feel better and have fewer symptoms.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | Female |
| Sponsor | Mackay Memorial Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06197295 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combined pharmacotherapy using solifenacin and mirabegron compared to solifenacin with vaginal estrogen cream in women suffering from detrusor overactivity. Women who have not responded to anti-muscarinic treatments are enrolled and divided into two groups to receive one of the two treatment regimens. The study evaluates both subjective outcomes, such as quality of life and symptom distress, and objective outcomes, including changes in urinary frequency and incontinence episodes. The goal is to determine which treatment provides better relief from symptoms.
Who should consider this trial
Good fit: Ideal candidates are women with detrusor overactivity who have not responded to previous anti-muscarinic therapy.
Not a fit: Patients with contraindications to solifenacin, mirabegron, or estrogen therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women suffering from detrusor overactivity.
How similar studies have performed: Other studies have explored similar pharmacotherapy combinations, but this specific comparison is novel.
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 anti-muscarinics were enrolled for prospective study. Exclusion Criteria: * Postvoid urine retention before treatment * Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension * Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding. * Women who were on hormone replacement therapy within 3 months were also excluded from the study
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.