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No Current scope was available to perform procedure.
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| Name | Class |
|---|---|
| Indiana University | OTHER |
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The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HoLEP surgery with 22Fr | Active Comparator | HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. |
|
| HoLEP surgery with 28Fr | Experimental | HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HoLEP Surgery | Procedure | HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. | ||
| Measure | Description | Time Frame |
|---|---|---|
| Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths. | Measuring rates of immediate urinary incontinence or complications post-operation HoLEP using the Michigan Incontinence System Index (M-ISI) survey. | M-ISI survey completed at 1,4,12 weeks |
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Inclusion Criteria:• Age >18 years old Undergoing HoLEP for benign prostatic enlargement Eligible for same day catheter removal
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Physicians Urology | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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We hypothesize there will be lower rates of immediate urinary incontinence, and urethral stricture formation in patients undergoing HoLEP with smaller 22Fr sheaths compared to 28 Fr.
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This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively
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| 28 French sized rigid sheath |
| Device |
The 28Fr is the standard of care sheath size used at this site. |
|
|
| 22 French sized rigid sheath | Device | The 22Fr is the smaller, investigational sheath size to be used in this study. |
|
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |