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

NCT06275256 | Not Yet Recruiting Phase 3 FDA Device

• 1 other identifier: HS26226
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (6)

• Symptom Scores

  Using the IPSS (International Prostate Symptom Score) questionnaires to measure improvement in symptom scores

  1, 3, 6 months post-procedure

• Uroflow

  Measuring uroflow parameters such as Qmax pre and post procedure

  1, 3, 6 months post-procedure

• Uroflow

  Measuring uroflow parameters such as PVR (post-void residual volume) pre and post procedure

  1, 3, 6 months post-procedure

• Symptom Scores

  Using the MHSQ-EjD (Male Sexual Health Questionnaire) questionnaire to measure changes in symptom scores

  1, 3, 6 months post-procedure

• Symptom Scores

  Using the IIEF-15 (Index of Erectile Function) questionnaire to measure changes in symptom scores

  1, 3, 6 months post-procedure

• Symptom Scores

  Using the OAB-qSF (overactive bladder symptom and health-related quality of life short-form questionnaire) to measure changes in symptom scores

  1, 3, 6 months post-procedure

Secondary Outcomes (1)

• Pain Scale

  1, 3, 6 months post-procedure

Study Arms (2)

Rezum

EXPERIMENTAL

This arm will receive the Rezum procedure.

Procedure: Rezum

iTind

EXPERIMENTAL

This arm will receive the iTind Procedure

Device: iTind

Interventions

Rezum PROCEDURE

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.

Rezum

iTind DEVICE

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.

iTind

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Men's Health Clinic

Winnipeg, Manitoba, R3K 1M3, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Premal Patel, MD

CONTACT

204-221-4476; ppatel5@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 23, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)