NCT05946902

Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Far Eastern Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the impact of combined therapy on the heart rate variability, compared with monotherapy in women with overactive bladder syndrome. Secondary objective is to evaluate the impact of combined therapy on bladder blood perfusion.

Detailed description

Patients and methods: We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital, and will recruit 150 female patients with overactive bladder syndrome. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the urgency severity score, the overactive bladder symptom score questionnaire, and the King's health questionnaire before taking the drug and four weeks and twelve weeks after taking the drug. In addition, measurement of heart rate variability and bladder blood perfusion will be performed. Expected results: We will obtain the impact of monotherapy with tolterodine or mirabegron versus combined therapy on heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.

Conditions

• Female Patients With Overactive Bladder Syndrome

Interventions

Type	Name	Description
DRUG	tolterodine	tolterodine 4 mg per day
DRUG	mirabegron	mirabegron 25 mg per day
DRUG	tolterodine , mirabegron	tolterodine 4 mg and mirabegron 25 mg per day

Timeline

• Start date: 2023-09-12
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-07-14
• Last updated: 2023-09-13

Locations

1 site across 1 country: Taiwan