Trial Outcomes & Findings for Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence (NCT NCT01770691)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

up to 8 hours of use

Results posted on

2015-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	TIPI Vaginal Pessary 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
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TIPI Vaginal Pessary n=7 Participants 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
Age, Continuous	54.67 Years n=5 Participants
Sex/Gender, Customized Female	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SMD 12 2008 n=5 Participants 5 subjects used SMD 12 for up to 8 hours during 2008	SMD 12 2009 n=6 Participants 6 subjects used SMD 12 for up to 8 hours during 2009	SMD 9 n=7 Participants 7 subjects used SMD 9 for up to 8 hours	Cleared TIPI Device (G3) n=7 Participants 7 subjects used the cleared TIPI G3 for up to 8 hours
Mean Percentage of Pad Weight Gain (PWG) Change	90.8 Mean percentage of PWG change Standard Deviation 16.9	98.5 Mean percentage of PWG change Standard Deviation 1.35	99.3 Mean percentage of PWG change Standard Deviation 0.61	89.3 Mean percentage of PWG change Standard Deviation 17.9

Adverse Events

TIPI Vaginal Pessary

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TIPI Vaginal Pessary n=7 participants at risk 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
General disorders Spotting	28.6% 2/7 • Number of events 5
General disorders Discomfort	28.6% 2/7 • Number of events 2

Additional Information

Dr. Elan Ziv

ConTIPI LTD.

Phone: 972-4-627-6066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place