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 - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00688298

Purpose

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

Condition	Intervention	Phase
Stress Urinary Incontinence Intrinsic Sphincter Deficiency	Device: Prefyx PPS™ System Device: Advantage ™ System	Phase IV

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
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

Further study details as provided by Boston Scientific Corporation:

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 [ Time Frame: post procedure ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Physician-Procedure satisfaction questionnaire [ Time Frame: post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The percentage of patients who remain continent or improved following treatment at timed intervals [ Time Frame: 10 days, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	May 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental Female patients Greater than or 18 years of age, diagnosed with Stress Urinary Incontinence (SUI).	Device: Prefyx PPS™ System 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. Device: Advantage ™ System 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.

Arms

Assigned Interventions

Arm 1: Experimental

Female patients Greater than or 18 years of age, diagnosed with Stress Urinary Incontinence (SUI).

Device: Prefyx PPS™ System

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.

Device: Advantage ™ System

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688298

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Chair:	Lind, M.D.	North Shore University Hospital
Study Director:	Walsh, M.D.	Boston Scientific Corporation

More Information

Responsible Party:	Boston Scientific ( Kurt Douglass )
Study ID Numbers:	U0299
Study First Received:	May 28, 2008
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00688298
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009