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

NCT ID: NCT01770691

Last Updated: 2015-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-06-30

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

TIPI vaginal pessary

Intervention Type: DEVICE

TIPI vaginal pessary G3 model, and TIPI SMD's

Interventions

TIPI vaginal pessary

TIPI vaginal pessary G3 model, and TIPI SMD's

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assuta Hospital Systems

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elan Ziv, MD, OBGYN

Role: PRINCIPAL_INVESTIGATOR

Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel

Locations

Urodynamic Unit, Assuta Medical Centers

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

TIPI 004

Identifier Type: -

Identifier Source: org_study_id