Trial Outcomes & Findings for The Prefyx PPS™ System eRegistry (NCT NCT00688181)

NCT ID: NCT00688181

Last Updated: 2021-03-01

Results Overview

Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse

• Recruitment status: COMPLETED
• Target enrollment: 44 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-03-01

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	36
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	17
Overall Study Unknown Reason	4
Overall Study Non-clinical Reason	2

Baseline Characteristics

The Prefyx PPS™ System eRegistry

Baseline characteristics by cohort

Measure	Subjects Treated With the Prefyx PPS System n=36 Participants 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.
Age, Continuous	60.4 years STANDARD_DEVIATION 13.8 • n=93 Participants
Age, Customized Age Range in Years	60.4 years n=93 Participants
Sex: Female, Male Female	36 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	36 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 26 patients analyzed at 3 months

Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse

Outcome measures

Measure	Subjects Treated With the Prefyx PPS System n=26 Participants All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use.
Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up	26 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 12 patients analyzed at 12 months

Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse

Outcome measures

Measure	Subjects Treated With the Prefyx PPS System n=12 Participants All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use.
Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up	8 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 11 completed the Global Impression at 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).

Outcome measures

Measure	Subjects Treated With the Prefyx PPS System n=11 Participants All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use.
Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression	7 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Analysis was per protocol

Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness.

Outcome measures

Measure	Subjects Treated With the Prefyx PPS System n=36 Participants All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI) and treated with the Prefyx PPS System, excluding those patients meeting any of the contraindications as noted in the Directions For Use.
Number of Participants With Adverse Events	23 Participants

Adverse Events

Subjects Treated With the Prefyx PPS System

Serious events: 19 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subjects Treated With the Prefyx PPS System n=36 participants at risk 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.
Reproductive system and breast disorders Atrophy, Moderate	2.8% 1/36 • Number of events 1
Reproductive system and breast disorders Erosion, Moderate	2.8% 1/36 • Number of events 1
Renal and urinary disorders Incontinence, Mild	16.7% 6/36 • Number of events 6
Renal and urinary disorders Incontinence, Moderate	11.1% 4/36 • Number of events 4
Infections and infestations Infection, Mild	5.6% 2/36 • Number of events 2
Infections and infestations Infection, Moderate	2.8% 1/36 • Number of events 1
Gastrointestinal disorders Nausea, Moderate	2.8% 1/36 • Number of events 1
Nervous system disorders Numbness, Mild	2.8% 1/36 • Number of events 1
General disorders Other, Mild	2.8% 1/36 • Number of events 1
General disorders Other, Moderate	2.8% 1/36 • Number of events 1
Nervous system disorders Pain, Mild	11.1% 4/36 • Number of events 4
Nervous system disorders Pain, Severe	2.8% 1/36 • Number of events 1
Nervous system disorders Restlessness, Moderate	2.8% 1/36 • Number of events 1
Reproductive system and breast disorders Vaginal Burning, Moderate	2.8% 1/36 • Number of events 1

Other adverse events

Measure	Subjects Treated With the Prefyx PPS System n=36 participants at risk 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.
Reproductive system and breast disorders Atrophy, Moderate	2.8% 1/36 • Number of events 1
General disorders Bleeding, Mild	5.6% 2/36 • Number of events 2
Respiratory, thoracic and mediastinal disorders Difficulty Breathing, Mild	2.8% 1/36 • Number of events 1
Skin and subcutaneous tissue disorders Hematoma, Mild	2.8% 1/36 • Number of events 1
Renal and urinary disorders Hematuria, Mild	2.8% 1/36 • Number of events 1
Renal and urinary disorders Incontinence, Moderate	2.8% 1/36 • Number of events 1
General disorders Other, Mild	2.8% 1/36 • Number of events 1
Nervous system disorders Pain, Mild	8.3% 3/36 • Number of events 3
Nervous system disorders Pain, Moderate	2.8% 1/36 • Number of events 1
Gastrointestinal disorders Vomitting, Moderate	2.8% 1/36 • Number of events 1

Additional Information

Director, Clinical Operations

Boston Scientific Corporation

Phone: (952) 930-6300

Email: Teresa.Takle-Flach@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place