Stress Urinary Incontinence (SUI)
Conditions
Keywords
single use, disposable, pessary, stress urinary incontinence, sui
Brief summary
This study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 80 women with SUI. Efficacy will be assessed by pad weight gain, frequency of stress urinary incontinence events, and a quality of life questionnaire.
Interventions
DEVICEdisposable, single-use pessary
Sponsors
Procter and Gamble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 receive a signed copy; * be in generally good health as determined by the Investigator; * have a ≥ 3 month history of experiencing SUI (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
* 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 which could impact the safety of the subject or the outcome of the study; * for any reason, the Investigator decides that the subject should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Responders for Pad Weight Gain or SUI Episodes | from the 14-day baseline period to the last 7 days of 14-day device usage period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stress Urinary Incontinence Episodes | from the 14-day baseline period to the last 7 days of 14-day device usage period | change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome. |
| Change in Pad Weight Gain | from the 14-day baseline period to the last 7 days of 14-day device usage period | change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome. |
| Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7) | baseline and 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. |
| Percentage of Responders for Pad Weight Gain or SUI Episodes | from the 14-day baseline period to the first 7 days of 14-day device usage period | — |
Countries
United States
Participant flow
Pre-assignment details
145 subjects entered the 2-week baseline phase and 55 subjects dropped before treatment
Participants by arm
| Arm | Count |
|---|---|
| Pessary disposable, single-use pessary | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Pessary |
|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 11.18 |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
Percentage of Responders for Pad Weight Gain or SUI Episodes
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pessary | Percentage of Responders for Pad Weight Gain or SUI Episodes | 69 percentage of subjects |
Secondary
Change in Pad Weight Gain
change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary | Change in Pad Weight Gain | 4.68 grams/usage period |
Secondary
Change in Pad Weight Gain
change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary | Change in Pad Weight Gain | 5.7 grams/usage period |
Secondary
Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)
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.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary | Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7) | 24 units on a scale |
Secondary
Change in Stress Urinary Incontinence Episodes
change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary | Change in Stress Urinary Incontinence Episodes | 1.3 number of episodes/usage period |
Secondary
Change in Stress Urinary Incontinence Episodes
change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pessary | Change in Stress Urinary Incontinence Episodes | 1.46 episodes/usage period |
Secondary
Percentage of Responders for Pad Weight Gain or SUI Episodes
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pessary | Percentage of Responders for Pad Weight Gain or SUI Episodes | 67 percentage of subjects |