Trial Outcomes & Findings for A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (NCT NCT02160314)

Results Overview

proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

224 participants

Primary outcome timeframe

3 month

Results posted on

2016-02-15

224 subjects signed an informed consent, 79 did not meet inclusion/exclusion criteria and were screen failed.

Participant milestones
Measure	Pad Control absorbent pad control	Pessary pessary: disposable, single-use
Overall Study STARTED	73	72
Overall Study COMPLETED	72	59
Overall Study NOT COMPLETED	1	13

Reasons for withdrawal
Measure	Pad Control absorbent pad control	Pessary pessary: disposable, single-use
Overall Study Adverse Event	0	6
Overall Study Protocol Violation	0	4
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	0	1

A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

Baseline characteristics by cohort
Measure	Pad Control n=73 Participants absorbent pad control Absorbent pad	Pessary n=72 Participants disposable, single-use pessary pessary: disposable, single-use pessary	Total n=145 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 10.24 • n=99 Participants	53.9 years STANDARD_DEVIATION 12.36 • n=107 Participants	53.6 years STANDARD_DEVIATION 11.3 • n=206 Participants
Sex: Female, Male Female	73 Participants n=99 Participants	72 Participants n=107 Participants	145 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

Timeframe: 3 month

Population: Intent-to-treat (ITT)

proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event

Outcome measures
Measure	Pad Control n=73 Participants absorbent pad control Absorbent pad	Pessary n=72 Participants disposable, single-use pessary pessary: disposable, single-use pessary
Treatment-emergent Serious Adverse Event	0 participants	0 participants

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Pad Control n=73 participants at risk absorbent pad control	Pessary n=72 participants at risk disposable, single-use pessary
Investigations Candida test positive	5.5% 4/73 • Number of events 5 • 3 months All AEs as reported by the subject from Visit 1 (screening) through Visit 5 (exit) were recorded.	0.00% 0/72 • 3 months All AEs as reported by the subject from Visit 1 (screening) through Visit 5 (exit) were recorded.
Infections and infestations Upper Respiratory Tract Infection	5.5% 4/73 • Number of events 4 • 3 months All AEs as reported by the subject from Visit 1 (screening) through Visit 5 (exit) were recorded.	4.2% 3/72 • Number of events 3 • 3 months All AEs as reported by the subject from Visit 1 (screening) through Visit 5 (exit) were recorded.
Reproductive system and breast disorders vaginal hemorrhage	0.00% 0/73 • 3 months All AEs as reported by the subject from Visit 1 (screening) through Visit 5 (exit) were recorded.	5.6% 4/72 • Number of events 6 • 3 months All AEs as reported by the subject from Visit 1 (screening) through Visit 5 (exit) were recorded.

Procter & Gamble Company Global Clinical Sciences

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