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

Boston Scientific

Status

Completed

Conditions

Intrinsic Sphincter Deficiency

Stress Urinary Incontinence

Treatments

Device: Advantage ™ System

Device: Prefyx PPS™ System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00688298

U0299

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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