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

Assuta Hospital Systems

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Device: TIPI vaginal pessary

Study type

Interventional

Funder types

Other

Identifiers

NCT01770691

TIPI 004

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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