Stress Urinary Incontinence
Conditions
Brief summary
Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).
Detailed description
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.
Interventions
DEVICEThe Prefyx PPS™ Pre-pubic Sling System
device designed to treat female stress urinary incontinence (SUI).
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting for treatment of female Urinary Stress Incontinence (SUI)
Exclusion criteria
* Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies. * Any patients with soft tissue pathology into which the implant is to be placed. * Patients with any pathology which would compromise implant placement. * Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up | 3 months | Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse |
| Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up | 12 months | Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse |
| Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression | 12 months | 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). |
| Number of Participants With Adverse Events | 12 months | Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Non-clinical Reason | 2 |
| Overall Study | Unknown Reason | 4 |
Baseline characteristics
| Characteristic | Subjects Treated With the Prefyx PPS System |
|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 13.8 |
| Age, Customized Age Range in Years | 60.4 years |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 36 |
| serious Total, serious adverse events | 19 / 36 |
Outcome results
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
Time frame: 12 months
Population: 12 patients analyzed at 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Treated With the Prefyx PPS System | Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up | 8 Participants |
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
Time frame: 3 months
Population: 26 patients analyzed at 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Treated With the Prefyx PPS System | Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up | 26 Participants |
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).
Time frame: 12 months
Population: 11 completed the Global Impression at 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Treated With the Prefyx PPS System | Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression | 7 Participants |
Primary
Number of Participants With Adverse Events
Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness.
Time frame: 12 months
Population: Analysis was per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Treated With the Prefyx PPS System | Number of Participants With Adverse Events | 23 Participants |