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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01770691
First received: January 16, 2013
Last updated: January 15, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Device: TIPI vaginal pessary

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • Mean Percentage of Pad Weight Gain (PWG) Change [ Time Frame: up to 8 hours of use ] [ Designated as safety issue: No ]

    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.



Enrollment: 7
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Device: TIPI vaginal pessary
TIPI vaginal pessary G3 model, and TIPI SMD's

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770691

Locations
Israel
Urodynamic Unit, Assuta Medical Centers
Tel Aviv, Israel
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Elan Ziv, MD, OBGYN Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel
  More Information

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01770691     History of Changes
Other Study ID Numbers: TIPI 004
Study First Received: January 16, 2013
Results First Received: May 13, 2014
Last Updated: January 15, 2015
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on September 02, 2015