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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezum | Experimental | This arm will receive the Rezum procedure. |
|
| iTind | Experimental | This arm will receive the iTind Procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Premal Patel, MD | Contact | 204-221-4476 | ppatel5@hsc.mb.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Men's Health Clinic | Winnipeg | Manitoba | R3K 1M3 | Canada |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 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. |
|
| D052801 |
| Male Urogenital Diseases |