Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05040984
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 24.9

Study Details

Study Description

Brief Summary

A retrospective analysis of medical records at Far Eastern Memorial Hospital from January 2008 to May 2020 about female patients with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment. Factors affecting persistence of OAB medications will be analyzed.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Syndrome	Drug: Solifenacin Oral Tablet; Drug: Mirabegron 25mg

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome
• Actual Study Start Date: Apr 30, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
solifenacin	Drug: Solifenacin Oral Tablet; Solifenacin 1 tablet per day
mirabegron	Drug: Mirabegron 25mg; Mirabegron 1 tablet per day

Outcome Measures

Primary Outcome Measures

1. Predictors of persistence of mirabegron versus solifenacin use [13 years]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Women with overactive bladder syndrome received solifenacin or mirabegron as the initial treatment

Exclusion Criteria:

• <20 year-old

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 of Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05040984
• Other Study ID Numbers: 110053-E
• First Posted: Sep 10, 2021
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• 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 Mar 11, 2022