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This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pessary device | Experimental | pessary (disposable intra-vaginal device) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pessary (disposable intra-vaginal device) | Device | pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 last 7 days of 14-day device usage period |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 14-day device usage period |
| Change in Stress Urinary Incontinence Episodes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders for Pad Weight Gain | from the 14-day baseline period to the last 7 days of 14-day device usage period | |
| Percentage of Responders for SUI Episodes | from the 14-day baseline period to the last 7 days of 14-day device usage period |
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 |
148 subjects entered the 2-week baseline phase and 65 dropped/failed before treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Pessary Device | pessary (disposable intra-vaginal device) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pessary Device | pessary (disposable intra-vaginal device) |
| 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 | 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 |
|
|
2 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 Device | pessary (disposable intra-vaginal device) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection (UTI) | Infections and infestations | Non-systematic Assessment | UTI |
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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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| ID | Term |
|---|---|
| D010570 | Pessaries |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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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 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | 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 1 | Posted | Median | Inter-Quartile Range | grams/usage period | from the 14-day baseline period to the first 7 days of 14-day device 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. | 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 | episodes/usage period | from the 14-day baseline period to the first 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 the end of treatment | Posted | Median | Inter-Quartile Range | units on a scale | baseline and end-of-treatment |
|
|
|
| Other Pre-specified | Percentage of Responders for Pad Weight Gain | 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 |
|
|
|
| Other Pre-specified | Percentage of Responders for 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 |
|
|
|
| 0 |
| 83 |
| 15 |
| 83 |
| vaginal hemorrhage | Reproductive system and breast disorders | Non-systematic Assessment | vaginal bleeding |
|
| vaginal discomfort | Reproductive system and breast disorders | Non-systematic Assessment |
|
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 |