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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Outcomes of Minimally Invasive Surgical Treatments (MIST) for Benign Prostatic Hyperplasia (BPH): A Single-Institution Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06275256
• Other study ID #: HS26226
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: University of Manitoba
• Contact: Premal Patel, MD
• Phone: 204-221-4476
• Email: ppatel5[@]hsc.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
Canada	Men's Health Clinic	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Scores	Using the IPSS (International Prostate Symptom Score) questionnaires to measure improvement in symptom scores	1, 3, 6 months post-procedure
Primary	Uroflow	Measuring uroflow parameters such as Qmax pre and post procedure	1, 3, 6 months post-procedure
Primary	Uroflow	Measuring uroflow parameters such as PVR (post-void residual volume) pre and post procedure	1, 3, 6 months post-procedure
Primary	Symptom Scores	Using the MHSQ-EjD (Male Sexual Health Questionnaire) questionnaire to measure changes in symptom scores	1, 3, 6 months post-procedure
Primary	Symptom Scores	Using the IIEF-15 (Index of Erectile Function) questionnaire to measure changes in symptom scores	1, 3, 6 months post-procedure
Primary	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	Pain Scale	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	1, 3, 6 months post-procedure