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

University of Manitoba

Status and phase: Not yet enrolling; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: Rezum; Device: iTind

Study type: Interventional

Funder types: Other

Identifiers

NCT06275256

HS26226

Details and patient eligibility

About

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.

Full description

This prospective study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients who are to undergo Rezum or iTind procedure for BPH/LUTS between March 2024 and March 2025 are to be included in the study. Patient meeting inclusion criteria and exclusion criteria will be recruited to participate in this study.

Inclusion criteria: patients > 18 years of age, undergoing Rezum or iTind treatment Exclusion criteria: ASA III or higher, active UTI within past week, age < 18 years of age, no informed consent Follow-up/data measurements will occur pre-procedure, immediately post procedure, 1 week, 6 weeks, and 3 months following procedure. At time of consultation pre-procedure, baseline symptom scores, uroflow parameters will be obtained. VAS pain score is to be obtained during procedure, immediately post procedure, and at time of catheter or device removal 1 week post procedure. Uroflow parameters and symptoms scores will be again measured at 6 weeks and 3 months.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients > 18 years of age undergoing Rezum or iTind treatment

Exclusion criteria

• ASA 3 or higher, active UTI within past week, age < 18 years of age, no informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Rezum

Experimental group

Description:

This arm will receive the Rezum procedure.

Treatment:

Procedure: Rezum

iTind

Experimental group

Description:

This arm will receive the iTind Procedure

Treatment:

Device: iTind