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Device

MIST Therapies for Enlarged Prostate

Phase 3
Waitlist Available
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients over 18 years of age undergoing Rezum or iTind treatment
Be older than 18 years old
Must not have
ASA 3 or higher
Patients under 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6 months post-procedure
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to study the outcomes of MIST therapies at a Men's Health Clinic in Winnipeg over one year. It will also compare the effectiveness and side effects of Rezum water vapor therapy with

Who is the study for?
This trial is for men over 18 with benign prostatic hyperplasia (BPH), also known as an enlarged prostate, who are undergoing Rezum or iTind treatments. It's not suitable for those with a high surgical risk (ASA 3+), recent urinary tract infections, minors, or anyone unable to consent.
What is being tested?
The study compares two minimally invasive treatments for BPH at the Men's Health Clinic in Winnipeg: Rezum water vapor therapy and the iTind device. It aims to evaluate improvements in symptoms and urine flow while assessing side effects over one year.
What are the potential side effects?
Potential side effects of both Rezum and iTind may include discomfort during urination, blood in urine, frequent urination urges, inability to completely empty bladder immediately after procedure, and possible urinary tract infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and will undergo Rezum or iTind treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My health is severely impacted by my disease.
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I am under 18 years old.
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I have had a urinary tract infection in the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6 months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6 months post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Symptom Scores
Uroflow
Secondary study objectives
Pain Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: iTindExperimental Treatment1 Intervention
This arm will receive the iTind Procedure
Group II: RezumExperimental Treatment1 Intervention
This arm will receive the Rezum procedure.

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
621 Previous Clinical Trials
206,543 Total Patients Enrolled
~3 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
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