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

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