Back to resultsMirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation
Primary Purpose
Voiding Disorders
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Mirabegron, Propevirine, Solifenacin
Sponsored by
About this trial
This is an interventional treatment trial for Voiding Disorders
Eligibility Criteria
Inclusion Criteria:
- Patients older than age 18 years.
- Able to provide an informed consent.
- Denovo or recurrent cases with intermediate and high risk NMIBC eligible for intravesical BCG immunotherapy.
- Persistent LUTS after intravesical BCG induction.
Exclusion Criteria:
- International Prostate symptom score (IPSS) greater than 20.
- Post-void residual (PVR) volume greater than 50 ml.
- Use of medications for overactive bladder.
- Pelvic surgery within the previous 6 months.
- Hypersensitivity for BCG or any of the above mentioned drugs.
- Tumor recurrence during follow up period.
- Other medical conditions that would be adversely affected by anticholinergics such as history of urinary retention due to BPH(Benign prostatic hyperplasia), constipation and history of narrow angle glaucoma.
Sites / Locations
- Urology and Nephrology Center, Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Mirabegron arm
Propevirine arm
Solifenacin arm
Placebo arm
Arm Description
50 mg PO once daily
15 mg PO twice daily
10 mg PO once daily
starch tablet once daily
Outcomes
Primary Outcome Measures
Dysuria
Compare the percentage of reduction of dysuria as measured by Pain Visual Analouge Score at 3 month follow up after using propiverine, mirabegron and solifenacin versus placebo.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05490082
Brief Title
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation
Official Title
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voiding Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mirabegron arm
Arm Type
Active Comparator
Arm Description
50 mg PO once daily
Arm Title
Propevirine arm
Arm Type
Active Comparator
Arm Description
15 mg PO twice daily
Arm Title
Solifenacin arm
Arm Type
Active Comparator
Arm Description
10 mg PO once daily
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
starch tablet once daily
Intervention Type
Drug
Intervention Name(s)
Mirabegron, Propevirine, Solifenacin
Intervention Description
Efficacy comparison
Primary Outcome Measure Information:
Title
Dysuria
Description
Compare the percentage of reduction of dysuria as measured by Pain Visual Analouge Score at 3 month follow up after using propiverine, mirabegron and solifenacin versus placebo.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than age 18 years.
Able to provide an informed consent.
Denovo or recurrent cases with intermediate and high risk NMIBC eligible for intravesical BCG immunotherapy.
Persistent LUTS after intravesical BCG induction.
Exclusion Criteria:
International Prostate symptom score (IPSS) greater than 20.
Post-void residual (PVR) volume greater than 50 ml.
Use of medications for overactive bladder.
Pelvic surgery within the previous 6 months.
Hypersensitivity for BCG or any of the above mentioned drugs.
Tumor recurrence during follow up period.
Other medical conditions that would be adversely affected by anticholinergics such as history of urinary retention due to BPH(Benign prostatic hyperplasia), constipation and history of narrow angle glaucoma.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Abed, MSc
Phone
002001068896788
Email
ali.elmenair.abed@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elhefnawy, MD
Organizational Affiliation
Urology and Nephrology Center Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
Urology and Nephrology Center, Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassem Wadie, MD
Phone
0020502202222
Email
unc@mans.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation
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