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|
- Mean Percentage of Pad Weight Gain (PWG) Change [ Time Frame: up to 8 hours of use ] [ Designated as safety issue: No ]
All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages.
The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula:
% Reduction = 1-(Device/Baseline )*100
Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period.
|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. Not all subjects will use all types of SMD's
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|