Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-29 @ 4:57 AM
Study NCT ID:
NCT06275256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of MIST for BPH: A Single-Institution Prospective Study
Sponsor:
University of Manitoba
Organization:
Study Overview
Official Title:
Outcomes of Minimally Invasive Surgical Treatments (MIST) for Benign Prostatic Hyperplasia (BPH): A Single-Institution Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: