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Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).
Registry to gather information about the long term use of the Prefyx PPS System which utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone) for the treatment of SUI. No additional procedures are required beyond the physician's standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects treated with the Prefyx PPS System | All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI), excluding those patients meeting any of the contraindications as noted in the Directions For Use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Prefyx PPS™ Pre-pubic Sling System | Device | device designed to treat female stress urinary incontinence (SUI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up | Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse | 3 months |
| Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up | Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse | 12 months |
| Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression | Substantial improvement is measured by the participants' subjective feedback of their incontinence if they are cured, improved, same, or worse. Patients' Global Impression measures satisfaction (satisfied, or not satisfied). | 12 months |
| Number of Participants With Adverse Events | Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) should be eligible for enrollment in the PPS eRegistry. However, any patient meeting any of the contraindications should NOT be included as noted in the Directions For Use. Minors are excluded from the registry per contraindications in which mesh implants are contraindicated in 'patients with the potential for future growth'.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Walsh, M.D. | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Florida Urology Center | Pembroke Pines | Florida | 33028 | United States | ||
| OB/GYN Specialists of the Palm Beaches |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 58 patients were enrolled at 5 centers in the United States from November 2006 to November 2008. However, only 36 patients' data are included in this final synopsis report. A total of 22 patients were removed from the study database due to informed consent form non-compliance.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Treated With the Prefyx PPS System | All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI) and treated using the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Treated With the Prefyx PPS System | All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use. |
| 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 | Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up | Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse | 26 patients analyzed at 3 months | Posted | Number | Participants | 3 months |
|
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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 | Subjects Treated With the Prefyx PPS System | All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrophy, Moderate | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrophy, Moderate | Reproductive system and breast disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Boston Scientific Corporation | (952) 930-6300 | Teresa.Takle-Flach@bsci.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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| West Palm Beach |
| Florida |
| 33401 |
| United States |
| Urology Specialists of Atlanta, LLC /Northside Hospital | Atlanta | Georgia | 30328 | United States |
| Affiliates in Urology | Westland | Michigan | 48186 | United States |
| HillCrest Medical Center | Tulsa | Oklahoma | United States |
| years |
|
| Age, Customized | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up | Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse | 12 patients analyzed at 12 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression | Substantial improvement is measured by the participants' subjective feedback of their incontinence if they are cured, improved, same, or worse. Patients' Global Impression measures satisfaction (satisfied, or not satisfied). | 11 completed the Global Impression at 12 months | Posted | Number | Participants | 12 months |
|
|
|
| Primary | Number of Participants With Adverse Events | Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness. | Analysis was per protocol | Posted | Number | Participants | 12 months |
|
|
|
| 19 |
| 36 |
| 13 |
| 36 |
| Erosion, Moderate | Reproductive system and breast disorders |
|
| Incontinence, Mild | Renal and urinary disorders |
|
| Incontinence, Moderate | Renal and urinary disorders |
|
| Infection, Mild | Infections and infestations |
|
| Infection, Moderate | Infections and infestations |
|
| Nausea, Moderate | Gastrointestinal disorders |
|
| Numbness, Mild | Nervous system disorders |
|
| Other, Mild | General disorders |
|
| Other, Moderate | General disorders |
|
| Pain, Mild | Nervous system disorders |
|
| Pain, Severe | Nervous system disorders |
|
| Restlessness, Moderate | Nervous system disorders |
|
| Vaginal Burning, Moderate | Reproductive system and breast disorders |
|
| Bleeding, Mild | General disorders |
|
| Difficulty Breathing, Mild | Respiratory, thoracic and mediastinal disorders |
|
| Hematoma, Mild | Skin and subcutaneous tissue disorders |
|
| Hematuria, Mild | Renal and urinary disorders |
|
| Incontinence, Moderate | Renal and urinary disorders |
|
| Other, Mild | General disorders |
|
| Pain, Mild | Nervous system disorders |
|
| Pain, Moderate | Nervous system disorders |
|
| Vomitting, Moderate | Gastrointestinal disorders |
|
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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 |