Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT02348112|
Recruitment Status : Recruiting
First Posted : January 28, 2015
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment|
|Stress Urinary Incontinence||Device: Altis Sling Device: Transobturator or Retropubic Sling|
|Study Type :||Observational|
|Estimated Enrollment :||399 participants|
|Official Title:||A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Subjects will have an Altis sling placed to treat stress urinary incontinence.
Device: Altis Sling
Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
Other Name: Altis Single Incision Sling System
Transobturator or Retropubic Sling
Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Device: Transobturator or Retropubic Sling
Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.
- Observed device and/or procedure-related serious adverse events [ Time Frame: 36 months ]
- Observed effectiveness, defined as a reduction from baseline in 24-hour pad weight of at least 50% [ Time Frame: 6 months ]
- Observed rates for the following: organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary or neuromuscular problems [ Time Frame: 6, 12, 18, 24, and 36 months ]
- Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50%. [ Time Frame: 12, 18, 24, and 36 months ]
- Quality of Life [ Time Frame: 6, 12, 18, 24, and 36 months ]Measured through the following questionnaires: Patient Global Impression of Improvement (PGI-I), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), Surgical Satisfaction Questionnaire (SSQ-8), Visual Analog Scale for Pain (VAS Pain)
- Observed adverse events of the index procedure [ Time Frame: 6, 12, 18, 24, and 36 months ]
- Observed revision/re-surgery [ Time Frame: 6, 12, 18, 24, and 36 months ]
- Observed effectiveness for subjects considered dry (pad weight less than or equal to 4.0 grams) [ Time Frame: 6, 12, 18, 24, and 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348112
|Contact: Kris Veltumemail@example.com|
Show 29 Study Locations
|Principal Investigator:||Ty Erickson, MD||Rosemark WomenCare Specialists|