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

Mansoura University100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Voiding Disorders

Interventions

Mirabegron, Propevirine, SolifenacinDRUG

Efficacy comparison

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Central Contacts

Ali Abed, MSc

CONTACT

002001068896788 ali.elmenair.abed@gmail.com

Data from ClinicalTrials.gov

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