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

Voiding Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490082
• Other study ID #: MD.21.12.576
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: August 2022
• Source: Mansoura University
• Contact: Ali Abed, MSc
• Phone: 002001068896788
• Email: ali.elmenair.abed[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Voiding Disorders

Intervention

Drug:
• Mirabegron, Propevirine, Solifenacin
Efficacy comparison

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center, Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months