Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Females aged 18 to 60 years
Had ≥ 1 deliveries
Suffering from genuine stress urinary incontinence confirmed by urodynamic testing (Urodynamic stress urinary incontinence) and normal voiding without abnormal residual urine
Baseline PWG (no usage of TIPI device) ≥ 6gr/8hrs
Average reduction of urinary incontinence of at least 70% following 3 days usage of the cleared TIPI G3 device
The patient has the ability to understand the nature of the study and give her consent by signing a written informed consent form.
Successful experience with the use of vaginal tampons
Willing to undergo urodynamic investigation
Normal pap smear within past 24 months
Patient is able and agrees to arrive to the study site area for a period of about 4-6 hours during 6-12 non consequent study days.

Exclusion Criteria

Patient is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study
Patients with present or suspected urinary infection
Patients with present or suspected vaginal infection
Severely atrophic vagina
Women who did not manage to insert a vaginal tampon, for any reason, in the past
Abnormal vaginal bleeding
Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study
Was/is being treated for urinary incontinence by other means such as medications, surgical intervention etc. that might influence study results
Vaginal wall prolapse of any type reaching the level of the introitus (grade 2)
Co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study

Arm && Interventions

Group	Intervention	Description
TIPI vaginal pessary	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

Primary Outcome Measures

Name	Time	Method
Mean Percentage of Pad Weight Gain (PWG) Change	up to 8 hours of use	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.

Secondary Outcome Measures