MIST Therapies for Enlarged Prostate

Overseen By Premal Patel, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: University of Manitoba

Disqualifiers: ASA 3, Active UTI, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Immediate

20 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: iTind Experimental Treatment 1 Intervention

This arm will receive the iTind Procedure

Group II: Rezum Experimental Treatment 1 Intervention

This arm will receive the Rezum procedure.

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

Approved in European Union as iTind for:

• Benign Prostatic Hyperplasia (BPH)

Approved in United States as iTind for:

• Symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and older

Approved in Brazil as iTind for:

• Benign Prostatic Hyperplasia (BPH)

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+