Stress Urinary Incontinence (SUI) Clinical Trial
Official title:
Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy
| Verified date | August 2016 |
| Source | Atlantic Health System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.
| Status | Completed |
| Enrollment | 104 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period Exclusion Criteria: - previous surgical treatment for stress urinary incontinence (SUI) |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlantic Health System | Morristown | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Atlantic Health System |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cough Stress Test | Subjects will undergo a cough stress test to evaluate for stress urinary incontinence. | 12 months post procedure | No |
| Secondary | mesh related complications | possible mesh related complications such as: exposure/erosion, urinary retention, voiding dysfunction, chronic pain and dyspareunia will be collected throughout the study period | 12 months post procedure | Yes |
| Secondary | Urinary Distress Inventory 6 (UDI-6) | This validated questionnaires will be given to subject to collect subjective data | baseline and 12 months postoperatively | No |
| Secondary | Urinary Impact Questionnaire (UIQ-7) | this validated questionnaire will be completed by subject to collect subjective data | baseline and 12 months postoperatively | No |
| Secondary | Sandvick Severity Index Questionnaire | This validated questionnaire will be given to subjects to collect subjective data regarding urinary incontinence | baseline and 12 months postoperatively | No |