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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Mirabegron; Solifenacin Succinate

Criteria

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.