Back to resultsLow Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.
Primary Purpose
Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Low dose tadalafil 5 mg
Tolterodine 4 Mg Oral Capsule, Extended Release
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence
Exclusion Criteria:
- Active Urinary tract infection
- neurologic abnormality
- Pure Stress urinary incontinence
Sites / Locations
- Samer Morsy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group A Tadalafil 5 mg
Group B Tolterodine
Group C placebo
Arm Description
30 patients subjected to Daily dose of tadalafil 5mg
30 patients subjected to tolterodine 4 mg daily
30 patients subjected to placebo daily
Outcomes
Primary Outcome Measures
Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up
Evaluation of efficacy of tadalafil 5 mg
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04500860
Brief Title
Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.
Official Title
Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome
Detailed Description
90 female patients with overactive bladder syndrome divided into 3 groups group A subjected to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo. They are evaluated as using OAB symptoms score for 6 months follow up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A Tadalafil 5 mg
Arm Type
Active Comparator
Arm Description
30 patients subjected to Daily dose of tadalafil 5mg
Arm Title
Group B Tolterodine
Arm Type
Active Comparator
Arm Description
30 patients subjected to tolterodine 4 mg daily
Arm Title
Group C placebo
Arm Type
Placebo Comparator
Arm Description
30 patients subjected to placebo daily
Intervention Type
Drug
Intervention Name(s)
Low dose tadalafil 5 mg
Intervention Description
Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence
Intervention Type
Drug
Intervention Name(s)
Tolterodine 4 Mg Oral Capsule, Extended Release
Intervention Description
To compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo drugs
Primary Outcome Measure Information:
Title
Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up
Description
Evaluation of efficacy of tadalafil 5 mg
Time Frame
6 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence
Exclusion Criteria:
Active Urinary tract infection
neurologic abnormality
Pure Stress urinary incontinence
Facility Information:
Facility Name
Samer Morsy
City
Cairo
ZIP/Postal Code
12334
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.
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