Stress Urinary Incontinence (SUI)
Conditions
Keywords
single incision sling, cough stress test, MiniArc, UDI-6, UIQ-7, Sandvick Severity Index (SSI)
Brief summary
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.
Interventions
None listed
Sponsors
Atlantic Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough Stress Test | 12 months post procedure | Subjects will undergo a cough stress test to evaluate for stress urinary incontinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mesh related complications | 12 months post procedure | possible mesh related complications such as: exposure/erosion, urinary retention, voiding dysfunction, chronic pain and dyspareunia will be collected throughout the study period |
| Urinary Distress Inventory 6 (UDI-6) | baseline and 12 months postoperatively | This validated questionnaires will be given to subject to collect subjective data |
| Urinary Impact Questionnaire (UIQ-7) | baseline and 12 months postoperatively | this validated questionnaire will be completed by subject to collect subjective data |
| Sandvick Severity Index Questionnaire | baseline and 12 months postoperatively | This validated questionnaire will be given to subjects to collect subjective data regarding urinary incontinence |
Countries
United States
Outcome results
None listed