Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation
NCT ID: NCT05490082
Last Updated: 2022-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2022-03-01
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mirabegron arm
50 mg PO once daily
Mirabegron, Propevirine, Solifenacin
Efficacy comparison
Propevirine arm
15 mg PO twice daily
Mirabegron, Propevirine, Solifenacin
Efficacy comparison
Solifenacin arm
10 mg PO once daily
Mirabegron, Propevirine, Solifenacin
Efficacy comparison
Placebo arm
starch tablet once daily
Mirabegron, Propevirine, Solifenacin
Efficacy comparison
Interventions
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Mirabegron, Propevirine, Solifenacin
Efficacy comparison
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Ali Elmenair
principle investigator
Principal Investigators
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Ahmed Elhefnawy, MD
Role: STUDY_DIRECTOR
Urology and Nephrology Center Mansoura University
Locations
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Urology and Nephrology Center, Mansoura University
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MD.21.12.576
Identifier Type: -
Identifier Source: org_study_id
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