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Device

Rezum 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6 months post-procedure

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am over 18 and will undergo Rezum or iTind treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 6 months post-procedure

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Symptom Scores

Uroflow

Secondary outcome measures

Pain Scale

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,506 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are eligible patients able to enroll in this ongoing trial at the present time?

"As per the details on clinicaltrials.gov, this specific medical study is presently not in pursuit of new participants. It was first made public on March 1st, 2024 and underwent its latest revision on February 16th, 2024. While recruitment is currently closed for this trial, it's noteworthy that there are approximately 143 alternative clinical trials actively seeking candidates at present."

Answered by AI

What are the safety considerations associated with Rezum treatment for individuals?

"The safety assessment of Rezum by our team at Power is graded as 3, signifying that this Phase 3 trial has data backing its efficacy and multiple datasets supporting its safety."

Answered by AI

What are the preferred criteria for individuals who can take part in this research study?

"Individuals eligible for participation in this research must have a prostate gland that is enlarged and fall within the age range of 18 to 65 years. The total number of participants accepted into the study is limited to 20 individuals."

Answered by AI

Is the research study open to participants aged 65 and above?

"Patients eligible for participation in this research must fall within the age range of 18 to 65. It is noteworthy that there are a total of 27 trials tailored for individuals under 18 and an additional 112 studies geared towards those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Outcomes of MIST for BPH: A Single-Institution Prospective Study

Premal Patel, MD 2024. "Outcomes of MIST for BPH: A Single-Institution Prospective Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06275256.

All > Benign Prostatic Hyperplasia > Bph