Trial Outcomes & Findings for A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI) (NCT NCT02131311)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

145 participants

Primary outcome timeframe

from the 14-day baseline period to the last 7 days of 14-day device usage period

Results posted on

2016-03-24

Participant Flow

145 subjects entered the 2-week baseline phase and 55 subjects dropped before treatment

Participant milestones

Participant milestones
Measure	Pessary disposable, single-use pessary
Overall Study STARTED	90
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Pessary disposable, single-use pessary
Overall Study Adverse Event	2
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pessary n=90 Participants disposable, single-use pessary
Age, Continuous	52 years STANDARD_DEVIATION 11.18 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: from the 14-day baseline period to the last 7 days of 14-day device usage period

Population: Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 2

Outcome measures

Outcome measures
Measure	Pessary n=87 Participants disposable, single-use pessary disposable, single-use pessary
Percentage of Responders for Pad Weight Gain or SUI Episodes	69 percentage of subjects

SECONDARY outcome

Timeframe: from the 14-day baseline period to the last 7 days of 14-day device usage period

Population: Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 2

change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

Outcome measures

Outcome measures
Measure	Pessary n=88 Participants disposable, single-use pessary disposable, single-use pessary
Change in Stress Urinary Incontinence Episodes	1.46 episodes/usage period Interval 0.38 to 2.81

SECONDARY outcome

Timeframe: from the 14-day baseline period to the last 7 days of 14-day device usage period

Population: Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 2

change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.

Outcome measures

Outcome measures
Measure	Pessary n=87 Participants disposable, single-use pessary disposable, single-use pessary
Change in Pad Weight Gain	5.7 grams/usage period Interval 1.23 to 16.7

SECONDARY outcome

Timeframe: baseline and end-of-treatment

Population: Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data at end of treatment

The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.

Outcome measures

Outcome measures
Measure	Pessary n=86 Participants disposable, single-use pessary disposable, single-use pessary
Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)	24 units on a scale Interval 5.0 to 47.0

SECONDARY outcome

Timeframe: from the 14-day baseline period to the first 7 days of 14-day device usage period

Population: Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 1

change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.

Outcome measures

Outcome measures
Measure	Pessary n=88 Participants disposable, single-use pessary disposable, single-use pessary
Change in Stress Urinary Incontinence Episodes	1.3 number of episodes/usage period Interval 0.43 to 2.41

SECONDARY outcome

Timeframe: from the 14-day baseline period to the first 7 days of a 14-day device usage period

Population: Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 1

change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.

Outcome measures

Outcome measures
Measure	Pessary n=87 Participants disposable, single-use pessary disposable, single-use pessary
Change in Pad Weight Gain	4.68 grams/usage period Interval 1.27 to 18.5

SECONDARY outcome

Timeframe: from the 14-day baseline period to the first 7 days of 14-day device usage period

Population: Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 1

Outcome measures

Outcome measures
Measure	Pessary n=88 Participants disposable, single-use pessary disposable, single-use pessary
Percentage of Responders for Pad Weight Gain or SUI Episodes	67 percentage of subjects

Adverse Events

Pessary

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pessary n=90 participants at risk disposable, single-use pessary
Gastrointestinal disorders Diarrhea	6.7% 6/90 • Number of events 7 • two weeks All adverse events reported by the subject from study initiation \[Visit 1 (Screening)\] until study completion \[Visit 3 (End-of-Treatment)\] were recorded.

Additional Information

Mylissa Trowbridge

Procter & Gamble Company Global Clinical Sciences

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The STUDY SITE and PRINCIPAL INVESTIGATOR agree that all data, calculations, interpretations, opinions and recommendations regarding the STUDY (hereinafter referred to as "RESULTS") shall be the property of P\&G. The STUDY SITE and PRINCIPAL INVESTIGATOR agree to consider the RESULTS as INFORMATION subject to confidentiality restrictions
Publication restrictions are in place

Restriction type: OTHER