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


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


  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.