Comparing Mirabegron and Tolterodine treatments for women with overactive bladder
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
This study is testing whether taking Mirabegron or Tolterodine alone, or together, can help women with overactive bladder feel better over 12 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Far Eastern Memorial Hospital Academic / other |
| Locations | 1 site (Banqiao, New Taipei) |
| Trial ID | NCT05946902 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of monotherapy with either Mirabegron or Tolterodine compared to a combined treatment of both medications in women suffering from overactive bladder syndrome. It involves a randomized controlled design with 150 female participants who will undergo assessments of urgency severity, bladder symptoms, heart rate variability, and bladder blood perfusion before and after treatment. The study aims to determine the impact of these therapies on autonomic function and bladder health over a 12-week period.
Who should consider this trial
Good fit: Ideal candidates are women over 20 years old diagnosed with overactive bladder syndrome.
Not a fit: Patients with hypersensitivity to Mirabegron or Tolterodine, or those with certain contraindications such as uncontrolled hypertension or severe renal dysfunction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for women with overactive bladder syndrome, potentially improving their quality of life.
How similar studies have performed: While there have been studies on monotherapy for overactive bladder, this specific comparison of combined therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Banqiao, New Taipei
- Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital — Banqiao, New Taipei, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.