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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05490082
Other study ID # MD.21.12.576
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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