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

NCT05946902 | Unknown Phase 4

• 1 other identifier: 112019-F
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Patients With Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Improvement of overactive bladder symptoms

  Change of overactive bladder symptom score between groups

  12 weeks

Secondary Outcomes (2)

• Change of heart rate variability

  12 weeks

• Change of bladder blood perfusion

  12 weeks

Other Outcomes (1)

• Change of quality of life

  12 weeks

Study Arms (3)

mirabegron

ACTIVE COMPARATOR

mirabegron 25 mg

Drug: mirabegron

tolterodine

ACTIVE COMPARATOR

tolterodine 4 mg

Drug: tolterodine

combined therapy

EXPERIMENTAL

tolterodine 4 mg \& mirabegron 25 mg

Drug: tolterodine , mirabegron

Interventions

tolterodine DRUG

tolterodine 4 mg per day

tolterodine

mirabegron DRUG

mirabegron 25 mg per day

mirabegron

tolterodine , mirabegron DRUG

tolterodine 4 mg and mirabegron 25 mg per day

combined therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>20 years old .
• female patients with overactive bladder syndrome

You may not qualify if:

• 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.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Interventions

Tolterodine Tartrate; mirabegron

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief and Professor, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: September 12, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)