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

Mansoura University

Status and phase: Enrolling; Phase 3

Conditions: Voiding Disorders

Treatments: Drug: Mirabegron, Propevirine, Solifenacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05490082

MD.21.12.576

Details and patient eligibility

About

A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Mirabegron arm

Active Comparator group

Description:

50 mg PO once daily

Treatment:

Drug: Mirabegron, Propevirine, Solifenacin

Propevirine arm

Active Comparator group

Description:

15 mg PO twice daily

Treatment:

Drug: Mirabegron, Propevirine, Solifenacin

Solifenacin arm

Active Comparator group

Description:

10 mg PO once daily

Treatment:

Drug: Mirabegron, Propevirine, Solifenacin

Placebo arm

Placebo Comparator group

Description:

starch tablet once daily

Treatment:

Drug: Mirabegron, Propevirine, Solifenacin