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

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05946902
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Female Patients With Overactive Bladder Syndrome	Drug: tolterodine; Drug: mirabegron; Drug: tolterodine , mirabegron	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Jul 31, 2024
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: mirabegron mirabegron 25 mg	Drug: mirabegron; mirabegron 25 mg per day
Active Comparator: tolterodine tolterodine 4 mg	Drug: tolterodine; tolterodine 4 mg per day
Experimental: combined therapy tolterodine 4 mg & mirabegron 25 mg	Drug: tolterodine , mirabegron; tolterodine 4 mg and mirabegron 25 mg per day

Outcome Measures

Primary Outcome Measures

1. Improvement of overactive bladder symptoms [12 weeks]

   Change of overactive bladder symptom score between groups

Secondary Outcome Measures

1. Change of heart rate variability [12 weeks]

   Change of heart rate variability between groups

2. Change of bladder blood perfusion [12 weeks]

   Change of bladder blood perfusion between groups

Other Outcome Measures

1. Change of quality of life [12 weeks]

   Change of King's Health Questionnaire score between groups

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 20 years old .

• female patients with overactive bladder syndrome

Exclusion Criteria:

• Cases of hypersensitivity to mirabegron or tolterodine.

• Betanley is contraindicated in the following patients: uncontrolled severe hypertension.

• Dexotol is contraindicated in the following patients: known urethral diverticulum, known bladder malignancy, patients with urinary retention and gastric retention, patients with uncontrolled narrow-angle glaucoma, patients with renal dialysis, severe renal dysfunction (ie Inulin clearance rate (GFR<30 ml/min) or liver dysfunction (i.e. liver cirrhosis), use strong CYP3A4 inhibitors such as ketoconazole.

• Patients with myasthenia gravis.

• The patient is taking drugs that interact with tolterodine or mirabegron.

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 Professor, Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05946902
• Other Study ID Numbers: 112019-F
• First Posted: Jul 14, 2023
• Last Update Posted: Jul 14, 2023
• Last Verified: Jul 1, 2023

• 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; Mirabegron; Tolterodine Tartrate

Study Results

No Results Posted as of Jul 14, 2023