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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TIPI vaginal pessary
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Urodynamic Unit, Assuta Medical Centers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TIPI vaginal pessary

Arm Description

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

Outcomes

Primary Outcome Measures

Mean Percentage of Pad Weight Gain (PWG) Change
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.

Secondary Outcome Measures

Full Information

First Posted
January 16, 2013
Last Updated
January 15, 2015
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT01770691
Brief Title
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
Official Title
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIPI vaginal pessary
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
TIPI vaginal pessary
Intervention Description
TIPI vaginal pessary G3 model, and TIPI SMD's
Primary Outcome Measure Information:
Title
Mean Percentage of Pad Weight Gain (PWG) Change
Description
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.
Time Frame
up to 8 hours of use

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elan Ziv, MD, OBGYN
Organizational Affiliation
Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urodynamic Unit, Assuta Medical Centers
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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