Investigating the Adjunctive Use of Mirabegron in the Early Post-Rezum Procedure Period

NCT07017439 | Not Yet Recruiting Phase 3

• 1 other identifier: HS26978
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose conducting a randomized controlled trial at the Men's Health Clinic to evaluate whether patients who start and continue mirabegron postoperatively after undergoing Rezum therapy experience enhanced patient-reported outcomes, improved quality of life (QoL), and comparable rates of adverse events. There are no predicted adverse events of this study. There are no identified potential harms of this study.

Conditions

Benign Prostate Hypertrophy(BPH)

Outcome Measures

Primary Outcomes (2)

• Change in symptom scores

  Change in the following symptoms scores IPSS-QOL (higher scores indicate worser outcomes)

  Symptom scores will be taken pre-op at time of consultation and at 1, 2 and 4 week follow-up

• Change in symptom scores

  Change in OABSS symptom scores. (higher scores indicate worse outcomes)

  Symptom scores will be taken pre-op at time of consultation and at 1, 2 and 4 week follow-up

Secondary Outcomes (5)

• Rate of successful catheter removal

  Will be measured at the scheduled trial of void either 1 week or 2 weeks post-op

• Adverse events

  Possible adverse will be captured at time of consultation pre-op and at 1, 2 and 4 week follow-ups.

• rate of Qmax improvement

  Uroflow parameters will be captured at time of consultation pre-op and the 4 week follow-up post-op.

• rates of post void residual

  Uroflow parameters will be captured at time of consultation pre-op and the 4 week follow-up post-op.

• time to max flow

  Uroflow parameters will be captured at time of consultation pre-op and the 4 week follow-up post-op.

Study Arms (2)

Mirabegron post procedure

EXPERIMENTAL

In this arm, patients will receive a 30 day prescription of mirabegron post-procedure.

Drug: Beta-3 agonists (Mirabegron/Myrbetriq)

Placebo pill post rezum

SHAM COMPARATOR

Patients in this arm will be given the placebo pill following their procedure.

Other: Placebo group post rezum

Interventions

Beta-3 agonists (Mirabegron/Myrbetriq) DRUG

Patients in this arm will receive the medication in pill form following their procedure

Mirabegron post procedure

Placebo group post rezum OTHER

Patients in this arm will receive the placebo pill following their procedure.

Placebo pill post rezum

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>50, symptomatic LUTS with IPSS ≥ 10
• prostate volume 30-80cc on any imaging modality
• Qmax between 5 and 15ml/s with minimum voided volume of 125cc
• frequency ≥ 8 voids/day.

You may not qualify if:

• PVR greater than 300ml
• active UTI within past week
• previous surgical intervention for BPH
• documented urethral stricture disease
• bladder stones
• active malignancy
• any confirmed or suspected neurologic disease
• hypertension
• known insensitivity to B3 agonist
• current catheter dependence
• currently taking anticholinergic or B3 agonist.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3P 2S8, Canada

Location

Related Links

• Rezūm Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology, 126,
• Treating overactive bladder symptoms after transurethral prostatic surgery for benign prostatic hyperplasia - Which medication to choose?
• A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the β₃ adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder.

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Premal Patel, MD

CONTACT

204-221-4476; ppatel5@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Model Details: Single blinded, placebo controlled, randomized trial. Two arms, one is the intervention arm which will receive mirabegron post rezum procedure while the control arm will receive a placebo pill with non-medicinal ingredients.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: June 12, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CA (1)