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

Phase 3

Not yet recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: Rezum; Device: iTind

• Registration Number: NCT06275256
• Lead Sponsor: University of Manitoba

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Study Start: 2024-03
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rezum	Rezum	This arm will receive the Rezum procedure.
iTind	iTind	This arm will receive the iTind Procedure

Primary Outcome Measures

Name	Time	Method
Uroflow	1, 3, 6 months post-procedure	Measuring uroflow parameters such as PVR (post-void residual volume) pre and post procedure
Symptom Scores	1, 3, 6 months post-procedure	Using the OAB-qSF (overactive bladder symptom and health-related quality of life short-form questionnaire) to measure changes in symptom scores

Secondary Outcome Measures

Name	Time	Method
Pain Scale	1, 3, 6 months post-procedure	Using a visual analogue pain scale \[range 0-10; 0 = no pain, 10 = maximal pain\], pain will be assessed as reported by the patient post-operatively to determine their pain

Trial Locations

Locations (1)

Men's Health Clinic; 🇨🇦 Winnipeg, Manitoba, Canada