20 Participants Needed

MIST Therapies for Enlarged Prostate

PP
Overseen ByPremal Patel, MD
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: University of Manitoba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile.

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Lack of informed consent
I am under 18 years old.
My health is severely impacted by my disease.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Rezum or iTind procedure for BPH/LUTS

Immediate
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Visits at 1 week, 6 weeks, and 3 months post-procedure

Long-term Follow-up

Continued monitoring of symptom scores and uroflow parameters

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • iTind
  • Rezum
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: iTindExperimental Treatment1 Intervention
Group II: RezumExperimental Treatment1 Intervention

iTind is already approved in European Union, United States, Brazil for the following indications:

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Approved in European Union as iTind for:
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Approved in United States as iTind for:
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Approved in Brazil as iTind for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+
Unbiased ResultsWe believe in providing patients with all the options.
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