NCT06197295 Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity
| NCT ID | NCT06197295 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mackay Memorial Hospital |
| Condition | Urinary Bladder, Overactive |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-06-16 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2022-06-16 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.
Eligibility 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
Contact & Investigator
Hui-Hsuan Lau, MD
PRINCIPAL INVESTIGATOR
Mackay Memorial Hospital
Frequently Asked Questions
Who can join the NCT06197295 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 90 Years, studying Urinary Bladder, Overactive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06197295 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06197295 currently recruiting?
Yes, NCT06197295 is actively recruiting participants. Contact the research team at huihsuan1220@gmail.com for enrollment information.
Where is the NCT06197295 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06197295 clinical trial?
NCT06197295 is sponsored by Mackay Memorial Hospital. The principal investigator is Hui-Hsuan Lau, MD at Mackay Memorial Hospital. The trial plans to enroll 200 participants.