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

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2023

Interventions

  • Drug: Mirabegron, Propevirine, Solifenacin
    • Efficacy comparison

Arms, Groups and Cohorts

  • Active Comparator: Mirabegron arm
    • 50 mg PO once daily
  • Active Comparator: Propevirine arm
    • 15 mg PO twice daily
  • Active Comparator: Solifenacin arm
    • 10 mg PO once daily
  • Placebo Comparator: Placebo arm
    • starch tablet once daily

Clinical Trial Outcome Measures

Primary Measures

  • Dysuria
    • Time Frame: 3 months
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Elmenair, principle investigator – Mansoura University
  • Overall Official(s)
    • Ahmed Elhefnawy, MD, Study Director, Urology and Nephrology Center Mansoura University
  • Overall Contact(s)
    • Ali Abed, MSc, 002001068896788, ali.elmenair.abed@gmail.com

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