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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pessary | Experimental | disposable, single-use pessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disposable, single-use pessary | Device |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from the 14-day baseline period to the last 7 days of 14-day device usage period |
| Change in Pad Weight Gain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall Severance, MD | Radiant Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Center | Chandler | Arizona | 85224 | United States |
145 subjects entered the 2-week baseline phase and 55 subjects dropped before treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Pessary | disposable, single-use pessary |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat (ITT) population
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| ID | Title | Description |
|---|---|---|
| BG000 | Pessary | disposable, single-use pessary |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Responders for Pad Weight Gain or SUI Episodes | Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 2 | Posted | Number | percentage of subjects | from the 14-day baseline period to the last 7 days of 14-day device usage period |
|
|
two weeks
All adverse events reported by the subject from study initiation [Visit 1 (Screening)] until study completion [Visit 3 (End-of-Treatment)] were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pessary | disposable, single-use pessary |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA v 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mylissa Trowbridge | Procter & Gamble Company Global Clinical Sciences | trowbridge.mm@pg.com |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome. |
| from the 14-day baseline period to the last 7 days of 14-day device usage period |
| 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. | baseline and end-of-treatment |
| 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. | from the 14-day baseline period to the first 7 days of 14-day device usage period |
| Change in Pad Weight Gain | change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome. | from the 14-day baseline period to the first 7 days of a 14-day device usage period |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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. | Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 2 | Posted | Median | Inter-Quartile Range | episodes/usage period | from the 14-day baseline period to the last 7 days of 14-day device 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. | Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 2 | Posted | Median | Inter-Quartile Range | grams/usage period | from the 14-day baseline period to the last 7 days of 14-day device 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. | Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data at end of treatment | Posted | Median | Inter-Quartile Range | units on a scale | baseline and end-of-treatment |
|
|
|
| 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. | Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 1 | Posted | Median | Inter-Quartile Range | number of episodes/usage period | from the 14-day baseline period to the first 7 days of 14-day device 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. | Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 1 | Posted | Median | Inter-Quartile Range | grams/usage period | from the 14-day baseline period to the first 7 days of a 14-day device usage period |
|
|
|
| Secondary | Percentage of Responders for Pad Weight Gain or SUI Episodes | Intent-to-Treat (ITT) population. The "Number of Participants Analyzed" is the number subjects with available (non-missing) data in week 1 | Posted | Number | percentage of subjects | from the 14-day baseline period to the first 7 days of 14-day device usage period |
|
|
|
| 0 |
| 90 |
| 6 |
| 90 |
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
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |