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Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

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ClinicalTrials.gov Identifier: NCT04023253
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: Mirabegron Drug: Solifenacin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mirabegron
Receive mirabegron 2 mg treatment per day
Drug: Mirabegron
Mirabegron 25 mg

Experimental: solifenacin
Receive solifenacin 5 mg treatment per day
Drug: Solifenacin
Solifenacin 5 mg




Primary Outcome Measures :
  1. Global response assessment [ Time Frame: 12 weeks ]
    Between-group difference in the score of Global response assessment


Secondary Outcome Measures :
  1. Total score of Brief Symptoms Rating Scales [ Time Frame: 12 weeks ]
    Between-group difference in the changes of total score of Brief Symptoms Rating Scales

  2. Female sexual function index [ Time Frame: 12 weeks ]
    Between-group difference in the changes of total score of female sexual function index

  3. Bladder wall thickness [ Time Frame: 12 weeks ]
    Between-group difference in the changes of bladder wall thickness

  4. Blood flow index of the bladder [ Time Frame: 12 weeks ]
    Between-group difference in the changes of blood flow index of the bladder



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023253


Contacts
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Contact: Sheng-Mou Hsiao, MD +886289667000 ext 1818 smhsiao2@gmail.com

Locations
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Taiwan
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao, New Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital

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Responsible Party: Sheng-Mou Hsiao, Chief and Associate Professor, Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT04023253     History of Changes
Other Study ID Numbers: 108003-F
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Syndrome
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Mirabegron
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents