Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedAugust 5, 2022
August 1, 2022
1 year
June 30, 2022
August 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months
Study Arms (4)
Mirabegron arm
ACTIVE COMPARATOR50 mg PO once daily
Propevirine arm
ACTIVE COMPARATOR15 mg PO twice daily
Solifenacin arm
ACTIVE COMPARATOR10 mg PO once daily
Placebo arm
PLACEBO COMPARATORstarch tablet once daily
Interventions
Efficacy comparison
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nephrology Center, Mansoura University
Al Mansurah, 35516, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Elhefnawy, MD
Urology and Nephrology Center Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
June 30, 2022
First Posted
August 5, 2022
Study Start
March 1, 2022
Primary Completion
March 1, 2023
Study Completion
October 1, 2023
Last Updated
August 5, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share