Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation

Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial

A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation

Study Overview

• Status: Recruiting
• Conditions: Voiding Disorders
• Intervention / Treatment: Drug: Mirabegron, Propevirine, Solifenacin

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ali Abed, MSc; Phone Number: 002001068896788; Email: ali.elmenair.abed@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Recruiting
    • Urology and nephrology center, Mansoura University
    • Contact: Bassem Wadie, MD; Phone Number: 0020502202222; Email: unc@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mirabegron arm; 50 mg PO once daily	Drug: Mirabegron, Propevirine, Solifenacin; Efficacy comparison
Active Comparator: Propevirine arm; 15 mg PO twice daily	Drug: Mirabegron, Propevirine, Solifenacin; Efficacy comparison
Active Comparator: Solifenacin arm; 10 mg PO once daily	Drug: Mirabegron, Propevirine, Solifenacin; Efficacy comparison
Placebo Comparator: Placebo arm; starch tablet once daily	Drug: Mirabegron, Propevirine, Solifenacin; Efficacy comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Ahmed Elhefnawy, MD, Urology and Nephrology Center Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron; Solifenacin Succinate
• Other Study ID Numbers: MD.21.12.576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No