Back to resultsPost Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence, Intrinsic Sphincter Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prefyx PPS™ System
Advantage ™ System
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Female greater than 18 years of age
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Diagnosed with genuine SUI confirmed by urodynamic evaluation (urodynamic evaluations performed in the past 6 months are acceptable) and documented in the source documents as in patients charts, physicians notes, nurses notes, hospital records, etc.
- If the patient has an overactive bladder, the condition must be a minor component of the patient's disorder demonstrated by the urodynamic testing. This is a physician
- discretion for inclusion or exclusion in the study.
- Patients are willing to complete (PFDI-short form 20) and PISQ-12 at baseline, 3 months, 6 months and 12 months post-operatively.
Patient has documented SUI classification and the degree of hypermobility and/ or intrinsic sphincter abnormality (Q-Tip test). Confirm the patient's SUI diagnosis using one or more of the following procedures:
- Vaginal exam
- Cough provocation test
- Cystoscopic exam
- Patients must have a negative urine culture
- Patients' bladder capacity of 350cc or more
- Document voiding diary pre- and post-operatively
- Document post-void residual (PVR) of equal to or less than 100cc
- Patients that require a regional, general anesthesia or monitored anesthesia
- Pad test on baseline that demonstrate 5 grams or greater urine loss
- Patients are mentally competent and able to understand all study requirements
- Patients agree to read and sign the informed consent form prior to any study related procedures (screening/ baseline visit)
Exclusion Criteria:
- Patients who, in the clinical judgment of the investigator, are not suitable for this study
- Patients who, are in the investigator's opinion, mentally or legally incapacitated, or unable to read or understand written material, thereby preventing informed consent
- Patients who have participated in an investigational study (medical device or drug) within 30 days of study entry that may impact analysis of this device or have previously participated in the current trial
- Patients who are pregnant, lactating, or planning future pregnancies
- Patients with Diabetes Mellitus type I or II
- Patients with vesicourethral reflex, upper urinary tract obstruction, spastic bladder, or detrouser muscle instability
- Patient treated with corticosteriod or immunosuppresant agents within 90 days pre-operatively except for patients treated with inhaled steroids for the treatment of asthma
- Patients with compromised immune systems
- Patients with any acute cystitis or urethritis
- Patients that had previous urinary incontinence procedures
- Patients that had a previous radiation to the pelvis
- Patients with coagulopathy and/ or currently on anticoagulant medications
- Patients with known or suspected hypersensitivity to the mesh
- Patients that complain of pelvic pain and/ or dyspareunia
Sites / Locations
- North Shore University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Female patients Greater than or 18 years of age, diagnosed with Stress Urinary Incontinence (SUI).
Outcomes
Primary Outcome Measures
Measuring the amount of time to complete successful pre-pubic delivery approach and placement of the mesh in the mid-urethra and the number of difficulties associated with the placement
Document all types and number of complications associated with the pre-pubic delivery approach and mesh placement in the mid-urethra
Physician-Procedure satisfaction questionnaire
Secondary Outcome Measures
The percentage of patients who remain continent or improved following treatment at timed intervals
The percentage of patients who report substantial improvement and consider the surgery successful, as measured by patient self-reporting
Full Information
NCT ID
NCT00688298
First Posted
May 28, 2008
Last Updated
November 10, 2020
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00688298
Brief Title
Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence
Official Title
A Prospective, Single-Arm, Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
5. Study Description
Brief Summary
The pre-pubic approach of the tension free vaginal sling placement is a new approach in the treatment of SUI. The retropubic approach of the tension free vaginal sling is the standard method of device delivery; in addition a suprapubic and a transobturator approach are alternative methods of delivery. All of these delivery approach systems are intended to place the mesh "tension free" in the mid-urethra.
There are currently no studies that investigate the pre-pubic delivery approach in the United States. However, the largest series of cases in Europe using the pre-pubic system was done by Ulmsten (published in the European Journal of Obstetrics and Gynecology and Reproductive Biology) 107 (2003) 205-207, titled " Pre-Pubic tension free vaginal tape application: an alternative to classic tension free vaginal tape application in selected patients with SUI."
The primary objective of this study is to evaluate the feasibility of using a pre-pubic approach to the placement of a mid-urethral vaginal mesh.
Demonstrate the mesh can be properly placed in the mid-urethra using a pre-pubic approach;
Assess the performance of the delivery device by measuring the ease of use, technical complexity, and instrument difficulties
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Intrinsic Sphincter Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Female patients Greater than or 18 years of age, diagnosed with Stress Urinary Incontinence (SUI).
Intervention Type
Device
Intervention Name(s)
Prefyx PPS™ System
Intervention Description
A mesh implant intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
Intervention Type
Device
Intervention Name(s)
Advantage ™ System
Intervention Description
The Advantage Mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
Primary Outcome Measure Information:
Title
Measuring the amount of time to complete successful pre-pubic delivery approach and placement of the mesh in the mid-urethra and the number of difficulties associated with the placement
Time Frame
post procedure
Title
Document all types and number of complications associated with the pre-pubic delivery approach and mesh placement in the mid-urethra
Time Frame
post procedure
Title
Physician-Procedure satisfaction questionnaire
Time Frame
post procedure
Secondary Outcome Measure Information:
Title
The percentage of patients who remain continent or improved following treatment at timed intervals
Time Frame
10 days, 3 months, 6 months, 12 months
Title
The percentage of patients who report substantial improvement and consider the surgery successful, as measured by patient self-reporting
Time Frame
10 days, 3 months, 6 months, and 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female greater than 18 years of age
Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Diagnosed with genuine SUI confirmed by urodynamic evaluation (urodynamic evaluations performed in the past 6 months are acceptable) and documented in the source documents as in patients charts, physicians notes, nurses notes, hospital records, etc.
If the patient has an overactive bladder, the condition must be a minor component of the patient's disorder demonstrated by the urodynamic testing. This is a physician
discretion for inclusion or exclusion in the study.
Patients are willing to complete (PFDI-short form 20) and PISQ-12 at baseline, 3 months, 6 months and 12 months post-operatively.
Patient has documented SUI classification and the degree of hypermobility and/ or intrinsic sphincter abnormality (Q-Tip test). Confirm the patient's SUI diagnosis using one or more of the following procedures:
Vaginal exam
Cough provocation test
Cystoscopic exam
Patients must have a negative urine culture
Patients' bladder capacity of 350cc or more
Document voiding diary pre- and post-operatively
Document post-void residual (PVR) of equal to or less than 100cc
Patients that require a regional, general anesthesia or monitored anesthesia
Pad test on baseline that demonstrate 5 grams or greater urine loss
Patients are mentally competent and able to understand all study requirements
Patients agree to read and sign the informed consent form prior to any study related procedures (screening/ baseline visit)
Exclusion Criteria:
Patients who, in the clinical judgment of the investigator, are not suitable for this study
Patients who, are in the investigator's opinion, mentally or legally incapacitated, or unable to read or understand written material, thereby preventing informed consent
Patients who have participated in an investigational study (medical device or drug) within 30 days of study entry that may impact analysis of this device or have previously participated in the current trial
Patients who are pregnant, lactating, or planning future pregnancies
Patients with Diabetes Mellitus type I or II
Patients with vesicourethral reflex, upper urinary tract obstruction, spastic bladder, or detrouser muscle instability
Patient treated with corticosteriod or immunosuppresant agents within 90 days pre-operatively except for patients treated with inhaled steroids for the treatment of asthma
Patients with compromised immune systems
Patients with any acute cystitis or urethritis
Patients that had previous urinary incontinence procedures
Patients that had a previous radiation to the pelvis
Patients with coagulopathy and/ or currently on anticoagulant medications
Patients with known or suspected hypersensitivity to the mesh
Patients that complain of pelvic pain and/ or dyspareunia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Walsh, M.D.
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence
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