Stress Urinary Incontinence
Conditions
Keywords
stress urinary incontinence, SUI, pessary
Brief summary
This study will evaluate the safety of the pessary device by objective evaluation of vaginal wall integrity and subjective assessment of comfort during in-use conditions.
Interventions
DEVICEpessary
disposable, single-use pessary
DEVICEAbsorbent pad
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be female 18 years or older; * provide written informed consent prior to study participation and been given a signed copy; * be in generally good health as determined by the Investigator; * have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported); * be willing to use the pessary investigational device to control stress urinary incontinence; * be willing to comply with study requirements and instructions;
Exclusion criteria
* are pregnant, lactating, or planning to become pregnant during the study; * within 3 months post partum; * intrauterine device (IUD) placement of less than 6 months; * has self-reported difficulty emptying her bladder; * a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS; * experience difficulty inserting or wearing an intra-vaginal device, including a tampon; * vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months; * has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator and could impact the safety of the subject or the outcome of the study; or * for any reason, the Investigator decides that the subject should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent Serious Adverse Event | 3 month | proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event |
Countries
United States
Participant flow
Pre-assignment details
224 subjects signed an informed consent, 79 did not meet inclusion/exclusion criteria and were screen failed.
Participants by arm
| Arm | Count |
|---|---|
| Pad Control absorbent pad control
Absorbent pad | 73 |
| Pessary disposable, single-use pessary
pessary: disposable, single-use pessary | 72 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 6 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Pad Control | Pessary | Total |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 10.24 | 53.9 years STANDARD_DEVIATION 12.36 | 53.6 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 73 Participants | 72 Participants | 145 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 73 | 7 / 72 |
| serious Total, serious adverse events | 0 / 73 | 0 / 72 |
Outcome results
Primary
Treatment-emergent Serious Adverse Event
proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event
Time frame: 3 month
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pad Control | Treatment-emergent Serious Adverse Event | 0 participants |
| Pessary | Treatment-emergent Serious Adverse Event | 0 participants |