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| Name | Class |
|---|---|
| University of Calgary | OTHER |
| Ohio State University | OTHER |
| University of Alberta | OTHER |
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The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.
Patients with significant preoperative urgency and/or urge urinary incontinence (UUI) along with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) may require post-HoLEP anticholinergic, B-3 agonist, or intravesical OnabotulinumtoxinA administration. This injection is a guideline recommended for treatment in patients with severe irritative LUTS (urgency, UUI) and overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-detrusor OnabotulinumtoxinA Injection | Experimental | Injection of intra-detrusor OnabotulinumtoxinA into the bladder will be performed. |
|
| No intra-detrusor OnabotulinumtoxinA Injection | No Intervention | Injection of intra-detrusor OnabotulinumtoxinA into the bladder will not be performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Drug | Intra-detrusor OnabotulinumtoxinA is commonly known as botox |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improve Overactive Bladder Symptoms (OAB) utilizing botox injections into the bladder. | Examine the safety and effect of intra-detrusor botulinum toxin injections at the time of helium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in safety/ adverse effects | Identifying changes in post-op urinary retention, gross hematuria, UTI, ED visits and any additional complications. | 90 days |
| Difference in patient REDCap surveys (gross hematuria dysuria, incontinence) |
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Inclusion Criteria:
Exclusion Criteria:
Men experiencing overactive bladder symptoms
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alyssa McDonald | Contact | 312-695-8146 | Alyssa.McDonald@northwestern.edu | |
| Allaa Fadl-Alla | Contact | 312-695-8146 | Allaa.Fadlalla@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy Krambeck, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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Identifying symptom resolution at different time points (1 month, 3 months, 6 months)
| 6 months |
| Difference in efficacy endpoints (3-month clinic/telephone follow-up) | Identifying efficacy endpoints as they relate to the use of anti-cholinergics, incontinence survey, post void residuals, continence pads requirements if any. | 3 months |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |