MedTrace Logo

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

NCT06275256 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-23

No results posted yet for this study

Summary

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.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

PROCEDURE

Rezum

The Rezum device is inserted, a needle is deployed, and vapor is injected into the prostate for nine seconds. This vapor disperses between cells, then cools, releases heat, and gently disrupts the prostate's cells. Because of the initial swelling, a catheter is then inserted, which will remain for two to five days.

DEVICE

iTind

The iTind device is temporarily placed inside the prostatic urethra (the narrowed portion of the prostate), where it slowly expands and exerts gentle pressure at three precise points. The effect of the iTind is to widen the prostatic urethral opening through which urine can now flow more easily.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06275256 on ClinicalTrials.gov