Clinical Trials Logo
  1. Home
  2. Overactive Bladder Syndrome
  3. NCT04023253
  4. Details
NCT04023253 Clinical Trial

Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

Overactive Bladder Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04023253
Other study ID # 108003-F
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 1, 2019
Est. completion date December 31, 2024

Study information
Verified date September 2023
Source Far Eastern Memorial Hospital
Contact Sheng-Mou Hsiao, MD
Phone +886289667000
Email smhsiao2@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mirabegron
Mirabegron 25 mg
• Solifenacin
Solifenacin 5 mg

Locations
Country Name City State
Taiwan Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital Banqiao New Taipei

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Global response assessment Between-group difference in the score of Global response assessment 12 weeks
Secondary Total score of Brief Symptoms Rating Scales Between-group difference in the changes of total score of Brief Symptoms Rating Scales 12 weeks
Secondary Female sexual function index Between-group difference in the changes of total score of female sexual function index 12 weeks
Secondary Bladder wall thickness Between-group difference in the changes of bladder wall thickness 12 weeks
Secondary Blood flow index of the bladder Between-group difference in the changes of blood flow index of the bladder 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT02540707 - Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes Phase 4
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Not yet recruiting NCT06438861 - Role of Combination Therapy in Women With Refractory Overactive Bladder N/A
Completed NCT01114412 - Basic Sensations Coming From the Bladder
Recruiting NCT06045728 - Telerehabilitation for Overactive Bladder Syndrome in Obese Women N/A
Recruiting NCT03952299 - Oxybutynin for Post-surgical Bladder Pain and Urgency Phase 3
Active, not recruiting NCT03758235 - Overactive Bladder Syndrome: Incobotulinumtoxin Versus Onabotulinumtoxin Phase 3
Completed NCT01912885 - Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome N/A
Completed NCT04300400 - Treatment of the Overactive Bladder Syndrome: A Delphi Study
Recruiting NCT04982120 - Use of Repris Needle in Bladder Injection N/A
Completed NCT06123364 - Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Overactive Bladder N/A
Recruiting NCT06088394 - Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder N/A
Recruiting NCT05221021 - Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome Phase 4
Terminated NCT04256876 - TTNS Versus Sham Therapy for Children With iOAB (TaPaS Part I) N/A
Not yet recruiting NCT03331081 - Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome N/A
Recruiting NCT04873037 - BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder N/A
Completed NCT02024945 - Efficacy, Tolerability and Impact on Quality of Life of Propiverine in Patients With Overactive Bladder Syndrome Phase 4
Completed NCT00546637 - Fesoterodine "add-on" Male Overactive Bladder Study Phase 3
Not yet recruiting NCT06143397 - Effect of TTNS and PNS on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis. N/A
Recruiting NCT03044912 - Therapeutic Efficacy and Safety of Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan Phase 3