Trial Outcomes & Findings for A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence (NCT NCT01762345)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

148 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

148 subjects entered the 2-week baseline phase and 65 dropped/failed before treatment

Participant milestones

Participant milestones
Measure	Pessary Device pessary (disposable intra-vaginal device)
Overall Study STARTED	83
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Pessary Device pessary (disposable intra-vaginal device)
Overall Study Adverse Event	5
Overall Study Protocol Violation	2

Baseline Characteristics

A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pessary Device n=83 Participants pessary (disposable intra-vaginal device)
Age, Continuous	52.7 years STANDARD_DEVIATION 9.25 • n=5 Participants
Sex: Female, Male Female	83 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

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 Device n=76 Participants pessary (disposable intra-vaginal device)
Change in Pad Weight Gain	2.67 grams/usage period Interval 0.12 to 12.7

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

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 Device n=76 Participants pessary (disposable intra-vaginal device)
Change in Stress Urinary Incontinence Episodes	0.92 episodes/usage period Interval 0.22 to 1.93

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 pad weight gain. Positive values are indicative of efficacious outcome.

Outcome measures

Outcome measures
Measure	Pessary Device n=82 Participants pessary (disposable intra-vaginal device)
Change in Pad Weight Gain	2.36 grams/usage period Interval 0.16 to 11.7

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 Device n=82 Participants pessary (disposable intra-vaginal device)
Change in Stress Urinary Incontinence Episodes	0.65 episodes/usage period Interval 0.17 to 1.66

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 the 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 Device n=82 Participants pessary (disposable intra-vaginal device)
Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)	9.52 units on a scale Interval 0.0 to 28.6

OTHER_PRE_SPECIFIED 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 Device n=83 Participants pessary (disposable intra-vaginal device)
Percentage of Responders for Pad Weight Gain	36.6 percentage of subjects

OTHER_PRE_SPECIFIED 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 Device n=83 Participants pessary (disposable intra-vaginal device)
Percentage of Responders for SUI Episodes	42.7 percentage of subjects

Adverse Events

Pessary Device

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pessary Device n=83 participants at risk pessary (disposable intra-vaginal device)
Infections and infestations urinary tract infection (UTI)	6.0% 5/83 • Number of events 5 • 2 weeks All adverse events reported by the subject from study initiation \[Visit 1 (Screening)\] until study completion \[Visit 3 (End-of-Treatment)\] were recorded.
Reproductive system and breast disorders vaginal hemorrhage	6.0% 5/83 • Number of events 5 • 2 weeks All adverse events reported by the subject from study initiation \[Visit 1 (Screening)\] until study completion \[Visit 3 (End-of-Treatment)\] were recorded.
Reproductive system and breast disorders vaginal discomfort	6.0% 5/83 • Number of events 8 • 2 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