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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05490082

Enrollment

100

Registered

2022-08-05

Start date

2022-03-01

Completion date

2023-10-31

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Voiding Disorders

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

Interventions

DRUGMirabegron, Propevirine, Solifenacin

Efficacy comparison

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactAli Abed, MSc

ali.elmenair.abed@gmail.com002001068896788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026