Benign Prostatic Hyperplasia
Conditions
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.
Interventions
PROCEDURERezum
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.
DEVICEiTind
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.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Scores | 1, 3, 6 months post-procedure | Using the IPSS (International Prostate Symptom Score) questionnaires to measure improvement in symptom scores |
| Uroflow | 1, 3, 6 months post-procedure | Measuring uroflow parameters such as Qmax pre and post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactPremal Patel, MD
Outcome results
None listed