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

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05490082

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Voiding Disorders	Drug: Mirabegron, Propevirine, Solifenacin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mirabegron arm 50 mg PO once daily	Drug: Mirabegron, Propevirine, Solifenacin Efficacy comparison
Active Comparator: Propevirine arm 15 mg PO twice daily	Drug: Mirabegron, Propevirine, Solifenacin Efficacy comparison
Active Comparator: Solifenacin arm 10 mg PO once daily	Drug: Mirabegron, Propevirine, Solifenacin Efficacy comparison
Placebo Comparator: Placebo arm starch tablet once daily	Drug: Mirabegron, Propevirine, Solifenacin Efficacy comparison

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology and Nephrology Center, Mansoura University	Mansoura		Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

Study Director: Ahmed Elhefnawy, MD, Urology and Nephrology Center Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Elmenair, principle investigator, Mansoura University

ClinicalTrials.gov Identifier:

NCT05490082

Other Study ID Numbers:

MD.21.12.576

First Posted:

Aug 5, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lower Urinary Tract Symptoms

Solifenacin Succinate

Mirabegron

Study Results

No Results Posted as of Aug 5, 2022