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Holmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope. It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. Currently, to our knowledge, there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes. The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22F Sheath Size | Active Comparator | Comparator arm for procedures using 22F sheath size |
|
| 26F Sheath Size | Active Comparator | Comparator arm for procedures using 26F sheath size |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 22F Sheath Size | Device | Participants in this group will have the 22F sheath size used in their procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Operating Time | Operating time as measured during the procedure measured in minutes. | Intra-op |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Catheter Removal | Time from end of procedure to the removal of catheter measured in minutes. | Within 6 hours of procedure completion |
| Length of Hospital Stay | Time from end of procedure to participant discharge from the hospital in minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rabail Siddiqui | Contact | (807) 684-6000 | rabail.siddiqui@tbh.net | |
| Shalyn Littlefield | Contact | (807) 684-6000 | shalyn.littlefield@tbh.net |
| Name | Affiliation | Role |
|---|---|---|
| Hazem Elmansy | Thunder Bay Regional Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thunder Bay Regional Health Sciences Centre | Recruiting | Thunder Bay | Ontario | P7B 6V4 | 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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| 26F Sheath Size | Device | Participants in this group will have the 26F sheath size used in their procedure. |
|
| Within 6 hours of procedure completion |
| Continence status | Self-report from the participant on their continence. | One year post-procedure |
| International Prostate Symptom Score | Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35. | One year post-procedure |
| Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS) | Response to the last question on the IPSS: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible | One year post-procedure |
| Peak flow rate | Measured as Qmax "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible | One year post-procedure |
| Post-void residual | PVR "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible | One year post-procedure |
| Rate of Complications | Occurrence of procedure-related complications | One year post-procedure |
| D052801 |
| Male Urogenital Diseases |