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

NCT01770691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2015-01-16

Study results available
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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

Interventions

DEVICE

TIPI vaginal pessary

TIPI vaginal pessary G3 model, and TIPI SMD's

Sponsors & Collaborators

  • Assuta Hospital Systems

    lead OTHER

Principal Investigators

  • Elan Ziv, MD, OBGYN · Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01770691 on ClinicalTrials.gov