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| ID | Type | Description | Link |
|---|---|---|---|
| 350017 |
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The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urethrovesical Sling | Experimental | Surgisis Male Sling placed at the time of prostatectomy |
|
| Control | Active Comparator | Prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostatectomy | Procedure |
| ||
| Surgisis Male Sling |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Continent Patients Post Prostatectomy | 1 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chandru Sundaram, MD | Indiana Cancer Pavilion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States | ||
| Urology of San Antonio Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Urethrovesical Sling | Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy. |
| FG001 | Control | No sling placed at the time of prostatectomy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
147 patients were treated with the study procedure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Urethrovesical Sling | Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy. |
| BG001 | Control | No sling placed at the time of prostatectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Continent Patients Post Prostatectomy | Posted | Number | participants | 1 Month |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Urethrovesical Sling | Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Hodde, Clinical Affairs Manager | Cook Biotech Incorporated | 765-497-3355 | jhodde@CookBiotech.com |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| ID | Term |
|---|---|
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Device |
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 2 |
| 73 |
| 0 |
| 73 |
| EG001 | Control | No sling placed at the time of prostatectomy | 0 | 74 | 0 | 74 |
| Hospitalization | Infections and infestations | Systematic Assessment |
|
| Intervention to prevent impairment | Renal and urinary disorders | Systematic Assessment |
|
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| 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 |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |