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Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life.
The purpose of this study is to evaluate the performance of new designs of the TIPI device, a conservative, disposable, treatment for temporary management of SUI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIPI vaginal pessary | Experimental | Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all types of SMD's |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIPI vaginal pessary | Device | TIPI vaginal pessary G3 model, and TIPI SMD's |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage of Pad Weight Gain (PWG) Change | All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages. The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula: % Reduction = 1-(Device/Baseline )*100 Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period. | up to 8 hours of use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elan Ziv, MD, OBGYN | Urodynamic Unit, Assuta Medical Centers, Tel Aviv, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urodynamic Unit, Assuta Medical Centers | Tel Aviv | Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | TIPI Vaginal Pessary | Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all SMD'S TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TIPI Vaginal Pessary | Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's |
| 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 | Mean Percentage of Pad Weight Gain (PWG) Change | All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages. The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula: % Reduction = 1-(Device/Baseline )*100 Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period. | Posted | Mean | Standard Deviation | Mean percentage of PWG change | up to 8 hours of use |
|
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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 | TIPI Vaginal Pessary | Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spotting | General disorders | Non-systematic Assessment | Six (6) spotting (small blood spots detected on the TIPI cover after removal) events out of 55 usages were recored with the main TIPI SMDs. All adverse events were considered to be mild, minimal and temporary, and resolved with no sequelae. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elan Ziv | ConTIPI LTD. | 972-4-627-6066 | eziv@contipi.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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| Years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| SMD 12 2008 |
5 subjects used SMD 12 for up to 8 hours during 2008 |
| OG001 | SMD 12 2009 | 6 subjects used SMD 12 for up to 8 hours during 2009 |
| OG002 | SMD 9 | 7 subjects used SMD 9 for up to 8 hours |
| OG003 | Cleared TIPI Device (G3) | 7 subjects used the cleared TIPI G3 for up to 8 hours |
|
|
| 0 |
| 7 |
| 4 |
| 7 |
|
| Spotting | General disorders | Non-systematic Assessment | Five (5) spotting (small blood spots detected on the TIPI cover after removal) events out of 42 usages were recorded with the cleared TIPI device. All adverse events were considered to be mild, minimal and temporary, and resolved with no sequela. |
|
| Discomfort | General disorders | Non-systematic Assessment | Two (2) discomfort events out of 42 usages of the cleared TIPI device were recorded. All adverse events were considered to be mild, minimal and temporary, and resolved with no sequela. |
|
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| 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 |