Trial Outcomes & Findings for Pippa Pessary Study (Clinical Trial) (NCT NCT05611970)
NCT ID: NCT05611970
Last Updated: 2026-03-13
Results Overview
A composite endpoint comprising of study participants achieving \>50% leak reduction with investigational device use (treatment) as compared to without investigational device use (baseline). The two components of the composite endpoint are 1) \>50% reduction in pad weight gain for the International Continence Society's standardized 1-hour pad weight test, conducted once with investigational device use and once without investigational device use; and/or 2) \>50% reduction in mean daily leak episodes during a participant-controlled home phase, comparing at least 7 days without investigational device use to at least 7 days with investigational device use.
TERMINATED
NA
7 participants
From baseline to 24 days
2026-03-13
Participant Flow
Participant milestones
| Measure |
Adult Females With Diagnosed Stress Urinary Incontinence (SUI)
Women, ages 18 and up, who suffer from objectively-diagnosed Stress Urinary Incontinence (SUI); have a \>3 month history of experiencing more than 3 episodes of SUI per week; and have not been diagnosed with any other form of urinary incontinence. Each participant serves as her own control (vaginal pessary use vs. no vaginal pessary).
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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4
|
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pippa Pessary Study (Clinical Trial)
Baseline characteristics by cohort
| Measure |
Intervention
n=7 Participants
Each study participant serves as her own control. Control is not wearing a vaginal pessary. Intervention is wearing a vaginal pessary.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=41 Participants
|
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=41 Participants
|
|
Age, Continuous
|
39.94 years
STANDARD_DEVIATION 2.88 • n=41 Participants
|
|
Sex: Female, Male
Female
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7 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
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0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
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7 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: From baseline to 24 daysPopulation: Effectiveness analyses were conducted on participants with evaluable paired outcome data obtained during both the control phase (without device use) and the intervention phase (with device use). Safety analyses include all enrolled participants who used the Pippa Fitness Pessary at least once, including participants who withdrew early or had incomplete data.
A composite endpoint comprising of study participants achieving \>50% leak reduction with investigational device use (treatment) as compared to without investigational device use (baseline). The two components of the composite endpoint are 1) \>50% reduction in pad weight gain for the International Continence Society's standardized 1-hour pad weight test, conducted once with investigational device use and once without investigational device use; and/or 2) \>50% reduction in mean daily leak episodes during a participant-controlled home phase, comparing at least 7 days without investigational device use to at least 7 days with investigational device use.
Outcome measures
| Measure |
Pippa Fitness Pessary
n=4 Participants
Adult women with stress urinary incontinence (SUI) used the Pippa Fitness Pessary during clinical assessments and at-home use periods. Each participant served as her own control, with outcomes compared between periods with device use and periods without device use. Effectiveness was assessed using 1-hour pad weight testing, daily urine leakage episode frequency, and quality-of-life questionnaires. Safety was assessed through adverse event monitoring, urinalysis, and vaginal examination.
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|---|---|
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Proportion of Participants With Diagnosed Stress Urinary Incontinence (SUI) Who Achieved >50% Reduction of Urine Leakage With Intervention
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.75 proportion of participants
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SECONDARY outcome
Timeframe: 24 daysPopulation: Quality of Life analyses were conducted on participants with evaluable paired outcome data obtained during both the control phase (without device use) and the intervention phase (with device use).
Change in Quality of Life as measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) at baseline and after treatment. The IIQ-7 assesses the psychosocial impact of urinary incontinence in women, specifically physical activity, travel, social relationships and emotional health. A total score is calculated by taking the average score of each QoL attribute responded to (ranging from 0 to 3) and multiplying it by 33 1/3 to put it on a standardized scale of 0 to 100. Higher scores indicate a greater negative impact of incontinence on the individual's quality of life.
Outcome measures
| Measure |
Pippa Fitness Pessary
n=4 Participants
Adult women with stress urinary incontinence (SUI) used the Pippa Fitness Pessary during clinical assessments and at-home use periods. Each participant served as her own control, with outcomes compared between periods with device use and periods without device use. Effectiveness was assessed using 1-hour pad weight testing, daily urine leakage episode frequency, and quality-of-life questionnaires. Safety was assessed through adverse event monitoring, urinalysis, and vaginal examination.
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|---|---|
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Change in Quality of Life at Baseline and 24 Days
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7.483 score on a scale
Standard Deviation 27.320
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Adverse Events
Pippa Fitness Pessary
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pippa Fitness Pessary
n=7 participants at risk
Adult women with stress urinary incontinence (SUI) used the Pippa Fitness Pessary during clinical assessments and at-home use periods. Each participant served as her own control, with outcomes compared between periods with device use and periods without device use. Effectiveness was assessed using 1-hour pad weight testing, daily urine leakage episode frequency, and quality-of-life questionnaires. Safety was assessed through adverse event monitoring, urinalysis, and vaginal examination.
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|---|---|
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Skin and subcutaneous tissue disorders
Increase in vaginal discharge
|
28.6%
2/7 • Number of events 2 • Adverse events were collected during the time each participant was active in the study, which was designed to last 24 days.
Mild - Events require minimal or no treatment and do not interfere with the participant's daily activities. Moderate - Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning. Severe - Events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.
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Musculoskeletal and connective tissue disorders
Muscle cramping
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14.3%
1/7 • Number of events 1 • Adverse events were collected during the time each participant was active in the study, which was designed to last 24 days.
Mild - Events require minimal or no treatment and do not interfere with the participant's daily activities. Moderate - Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning. Severe - Events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.
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Product Issues
Pinching of tissue during removal
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14.3%
1/7 • Number of events 1 • Adverse events were collected during the time each participant was active in the study, which was designed to last 24 days.
Mild - Events require minimal or no treatment and do not interfere with the participant's daily activities. Moderate - Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning. Severe - Events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place