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

Phase 3

• Conditions: Voiding Disorders
• Interventions: Drug: Mirabegron, Propevirine, Solifenacin

• Registration Number: NCT05490082
• Lead Sponsor: Mansoura University

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-06-30
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05
• Primary Completion: 2023-03
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Mirabegron, Propevirine, Solifenacin	starch tablet once daily
Solifenacin arm	Mirabegron, Propevirine, Solifenacin	10 mg PO once daily
Mirabegron arm	Mirabegron, Propevirine, Solifenacin	50 mg PO once daily
Propevirine arm	Mirabegron, Propevirine, Solifenacin	15 mg PO twice daily

Primary Outcome Measures

Name	Time	Method
Dysuria	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.

Trial Locations

Locations (1)

Urology and Nephrology Center, Mansoura University; 🇪🇬 Mansoura, Egypt