Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life.
The purpose of this study is to evaluate the performance of new designs of the TIPI device, a conservative, disposable, treatment for temporary management of SUI.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence|
- Pad Weight Gain (PWG) [ Time Frame: 6 Month ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: TIPI vaginal pessary
Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.
Device: TIPI vaginal pessary
TIPI vaginal pessary G3 model, and TIPI SMD's
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770691
|Urodynamic Unit, Assuta Medical Centers|
|Tel Aviv, Israel|
|Principal Investigator:||Elan Ziv, MD, OBGYN||Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel|