Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04023253
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and bladder blood flow.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Syndrome	Drug: Mirabegron; Drug: Solifenacin	Phase 3

Detailed Description

To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and blood flow.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparisons of the Impact of Beta-3 Agonist Versus Antimuscarinics on Psychological Distress, Sexual Function, Bladder Wall Thickness and Blood Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study.
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mirabegron Receive mirabegron 2 mg treatment per day	Drug: Mirabegron; Mirabegron 25 mg
Experimental: solifenacin Receive solifenacin 5 mg treatment per day	Drug: Solifenacin; Solifenacin 5 mg

Outcome Measures

Primary Outcome Measures

1. Global response assessment [12 weeks]

   Between-group difference in the score of Global response assessment

Secondary Outcome Measures

1. Total score of Brief Symptoms Rating Scales [12 weeks]

   Between-group difference in the changes of total score of Brief Symptoms Rating Scales

2. Female sexual function index [12 weeks]

   Between-group difference in the changes of total score of female sexual function index

3. Bladder wall thickness [12 weeks]

   Between-group difference in the changes of bladder wall thickness

4. Blood flow index of the bladder [12 weeks]

   Between-group difference in the changes of blood flow index of the bladder

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Overactive bladder syndrome

Exclusion Criteria:

• Allergy to mirabegron or solifenacin.

• Patients with severe hypertension who are difficult to control, known urethral diverticulum, known bladder malignant tumors, urinary retention patients, gastric retention patients, uncontrolled angular glaucoma patients, dialysis patients, severe renal dysfunction , moderate liver dysfunction, use strong inhibitors of CYP3A4 such as ketoconazole.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital	Banqiao	New Taipei	Taiwan	22050

Sponsors and Collaborators

• Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng-Mou Hsiao, Chief and Associate Professor, Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04023253
• Other Study ID Numbers: 108003-F
• First Posted: Jul 17, 2019
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Syndrome; Solifenacin Succinate; Mirabegron

Study Results

No Results Posted as of Feb 8, 2022