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This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IRBs. The sample size will consist of approximately 50 participants. Participants will undergo an initial control period in which preweighed pads will be worn for 7 consecutive days for 12 hours. This will be followed by device usage for 14 consecutive days where participants will wear both device and preweighed pads simultaneously. for 12 hours.
The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) disposable stress urinary incontinence (SUI) pessary device. Specifically, this study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 50 women with Stress Urinary Incontinence (SUI). Efficacy will be assessed by mean pad weight gain per hour, reduction of stress urinary incontinence events per day, and a quality of life questionnaire. The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RS-2 SUI Device | Other | Comparing use of device to non-treatment phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUI Device | Device | Pessary SUI device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase. | Pad weight gain (PWG) was measured by weighing used pads returned by participants and subtracting the pre-weight of that pad to obtain the total weight of leakage. The total weight of leakage was then divided by the number of hours the pad was worn by the participant to calculate the PWG/hr. The average PWG/hr for baseline was calculated by averaging the PWG/hr for the entire 7 days of the baseline phase. The average treatment PWG/hr for treatment phase was calculated by averaging the PWG/hr of the last 7 days of treatment phase. The percent change from baseline to treatment phase was then calculated. The objective was to show that PWG/hr is reduced by >50% during treatment phase. Thus, the null hypothesis is that the mean weight gain reduction per hour is <=50%, and the alternative is that it is >50%, from the control period (no device) to the treatment period (women wearing the device). | 7 days of the baseline phase and 7 days of treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase | Change in mean number of SUI episodes per day from the 7-day baseline period to the last 7 days of the 14-day device treatment period. Participants will record SUI episodes in the Study Diary during the baseline (7 days) and treatment (14 days) periods. Negative values are indicative of efficacious outcome. Each subject will have a change in the number of episodes per day from the control period to the treatment period. Specifically, the number of episodes will be recorded each day in the diary. For the control phase, there will be (at most) 7 days of data. The mean number of SUI episodes per day will be computed for each subject. The same measures will occur in the treatment period for the analysis period, the last 7 days. |
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Inclusion Criteria:
• Provision of signed and dated informed consent form
Exclusion Criteria:
• Is pregnant, or planning to become pregnant during the study
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| Name | Affiliation | Role |
|---|---|---|
| Omar Felipe Duenas Garcia, MD | West Virginia University Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| Allegheny Health Network/East Suburban OB/GYN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32453209 | Derived | Duenas-Garcia OF, Shapiro RE, Gaccione P. Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):360-364. doi: 10.1097/SPV.0000000000000861. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RS-2 SUI Device | All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
| |||||||||||||
| Baseline Phase |
| |||||||||||||
| Treatment Phase |
|
Analysis conducted on mITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | RS-2 SUI Device | Comparing use of device to non-treatment phase SUI Device: Pessary SUI device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | All analyses performed on mITT population. |
| 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 Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase. | Pad weight gain (PWG) was measured by weighing used pads returned by participants and subtracting the pre-weight of that pad to obtain the total weight of leakage. The total weight of leakage was then divided by the number of hours the pad was worn by the participant to calculate the PWG/hr. The average PWG/hr for baseline was calculated by averaging the PWG/hr for the entire 7 days of the baseline phase. The average treatment PWG/hr for treatment phase was calculated by averaging the PWG/hr of the last 7 days of treatment phase. The percent change from baseline to treatment phase was then calculated. The objective was to show that PWG/hr is reduced by >50% during treatment phase. Thus, the null hypothesis is that the mean weight gain reduction per hour is <=50%, and the alternative is that it is >50%, from the control period (no device) to the treatment period (women wearing the device). | mITT Population | Posted | Mean | 98.33% Confidence Interval | percent change | 7 days of the baseline phase and 7 days of treatment phase |
|
Through study completion, an average of 21 days.
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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 | RS-2 SUI Device | Comparing use of device to non-treatment phase SUI Device: Pessary SUI device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Disorders and Administration Site Conidtions - Other, Specify | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Manager | Rinovum Subsidiary 2, LLC. | 7242418932 | hwhitelam@rinovum.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2017 | Mar 25, 2019 | Prot_SAP_000.pdf |
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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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Efficacy and Safety Study, Single Group, Open Study, Open Label
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| 7 days of baseline period and last 7 days of treatment phase |
| Change in Quality of Life From Before Treatment Phase to After Treatment Phase | Change in Quality of Life as measured by the ICIQ-LUTSqol - The Quality of Life Questionnaire to be performed at baseline, before, and after treatment phase of the study is based on 20 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, 1 = 'Not at all,' 2= 'Slightly,' 3 = 'Moderately,' or 4 'A lot.' Each area is then assessed on a scale of 1-10 to see how much it bothers them. The Questionnaire is scored by taking the average score of items and then multiplying that value by 25 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 at the end of the Treatment Phase from post-baseline/before Treatment Phase, reflects improved quality of life. A reduction in score of > 3.7 is considered the Minimum Clinically Important Difference (MCID). | Before Treatment Phase and After Treatment Phase is complete |
| Adverse Events and Labs Evaluation to Determine Safety of the Device | Evaluation and analysis of AEs to determine safety as recommended in FDA SUI Clinical Trial Guidance - The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination. | 21 days |
| Monroeville |
| Pennsylvania |
| 15146 |
| United States |
| West Virginia University Medicine | Morgantown | West Virginia | 26501 | United States |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | All analyses performed on mITT population. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | RS-2 SUI Device | All participants underwent a baseline phase, followed by a two week treatment phase wearing the RS-2 SUI pessary for 14 consecutive days, 12 hours per day. Treatment phase leakage was then compared to baseline leakage for each individual patient to evaluate change in leakage while wearing RS-2 device. |
|
|
| Secondary | Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase | Change in mean number of SUI episodes per day from the 7-day baseline period to the last 7 days of the 14-day device treatment period. Participants will record SUI episodes in the Study Diary during the baseline (7 days) and treatment (14 days) periods. Negative values are indicative of efficacious outcome. Each subject will have a change in the number of episodes per day from the control period to the treatment period. Specifically, the number of episodes will be recorded each day in the diary. For the control phase, there will be (at most) 7 days of data. The mean number of SUI episodes per day will be computed for each subject. The same measures will occur in the treatment period for the analysis period, the last 7 days. | mITT population | Posted | Mean | 95% Confidence Interval | number of episodes | 7 days of baseline period and last 7 days of treatment phase |
|
|
|
| Secondary | Change in Quality of Life From Before Treatment Phase to After Treatment Phase | Change in Quality of Life as measured by the ICIQ-LUTSqol - The Quality of Life Questionnaire to be performed at baseline, before, and after treatment phase of the study is based on 20 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, 1 = 'Not at all,' 2= 'Slightly,' 3 = 'Moderately,' or 4 'A lot.' Each area is then assessed on a scale of 1-10 to see how much it bothers them. The Questionnaire is scored by taking the average score of items and then multiplying that value by 25 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 at the end of the Treatment Phase from post-baseline/before Treatment Phase, reflects improved quality of life. A reduction in score of > 3.7 is considered the Minimum Clinically Important Difference (MCID). | mITT population | Posted | Mean | 95% Confidence Interval | Change in QoL score | Before Treatment Phase and After Treatment Phase is complete |
|
|
|
| Secondary | Adverse Events and Labs Evaluation to Determine Safety of the Device | Evaluation and analysis of AEs to determine safety as recommended in FDA SUI Clinical Trial Guidance - The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination. | Safety population | Posted | Number | events | 21 days |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 22 |
| 73 |
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Renal and Urinary Disorders - Other, Specify (Asymptomatic Bacteruria) | Renal and urinary disorders | Systematic Assessment |
|
| Renal and Urinary Disorders - Other, Specify (Nocturia) | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Genital Edema | Reproductive system and breast disorders | Systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Uterine Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Dryness | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Hemorrhage (Spotting) | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Pain of Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Research results and associated data will be considered confidential until the earlier of: (i) the first publication or presentation thereof data according to the terms of this agreement; (ii) one (1) year after conclusion, abandonment, or termination of the Research at all sites.
| 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 |