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

• Sponsor: Assuta Hospital Systems (Other)
• Overall Status: Completed
• CT.gov ID: NCT01770691
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: TIPI vaginal pessary	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Mean Percentage of Pad Weight Gain (PWG) Change [up to 8 hours of use]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assuta Hospital Systems
• ClinicalTrials.gov Identifier: NCT01770691
• Other Study ID Numbers: TIPI 004
• First Posted: Jan 18, 2013
• Last Update Posted: Jan 16, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

Arm/Group Title	TIPI Vaginal Pessary
Arm/Group Description	Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all SMD'S TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's
Period Title: Overall Study
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	TIPI Vaginal Pessary
Arm/Group Description	Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's
Overall Participants	7
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	54.67
Sex/Gender, Customized (Number) [Number]
Female	7 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	7 100%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SMD 12 2008	SMD 12 2009	SMD 9	Cleared TIPI Device (G3)
Arm/Group Description	5 subjects used SMD 12 for up to 8 hours during 2008	6 subjects used SMD 12 for up to 8 hours during 2009	7 subjects used SMD 9 for up to 8 hours	7 subjects used the cleared TIPI G3 for up to 8 hours
Measure Participants	5	6	7	7
Mean (Standard Deviation) [Mean percentage of PWG change]	90.8 (16.9)	98.5 (1.35)	99.3 (0.61)	89.3 (17.9)

Adverse Events

Arm/Group Title	TIPI Vaginal Pessary
Arm/Group Description	Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's
All Cause Mortality
	TIPI Vaginal Pessary
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	TIPI Vaginal Pessary
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	TIPI Vaginal Pessary
	Affected / at Risk (%)	# Events
Total	4/7 (57.1%)
General disorders
Spotting	3/7 (42.9%)	6
Spotting	2/7 (28.6%)	5
Discomfort	2/7 (28.6%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.