Clinical trial NCT00463554: TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence
Official title: An Evaluation of the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: Incontinence
Stress Urinary
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 72
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with stress urinary incontinence

Brief summary: The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR\* System (Tension-free Support for Incontinence) in women with stress urinary incontinence (SUI).

Detailed description: The primary variable for effectiveness is \> 50% improvement on the subjective symptom Visual Analog Scale (VAS) at Visit 3/Week 5 (35 days post-surgery) to be accepted.

Eligibility criteria: Inclusion Criteria:

* Must be female with objective, demonstratable signs of SUI or stress predominant mixed incontinence and requires elective, primary surgical intervention.
* Must be at least 21 years old.
* Must be postmenopausal (amenorrhea) for at least 1 year or surgically sterile (bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of pregnancy) or has a negative pregnancy test prior to study entry and has decided to cease childbearing.
* Agrees to participate in the study, including all study related procedures and evaluations and documents this agreement by signing the IRB/EC-approved informed consent

Exclusion Criteria:

* Have any other coexistent pathology requiring concomitant surgery that may impact this procedure i.e. surgeries that involve the anterior vaginal wall (e.g. anterior colporrhaphy, diverticula, anterior Prolift) Any allowable concomitant surgery must be performed prior to the GYNECARE TVT SECUR System surgery.
* Have intrinsic sphincter deficiency (ISD) \[Urethral Pressure Profile (UPP) with a maximum urethral closing pressure (MUCP) \< 20cm H2O or Leak Point Pressure (LPP) \< 60\].
* Have an active urinary tract infection (UTI) or vaginal infection at time of surgery.
* Have a fixed urethra (\< 30° mobility on Q-Tip Straining Test).
* Have had prior incontinence surgery.
* Have a post-void residual volume \> 100mL.
* Have co-existent pelvic organ prolapse that is symptomatic or extends beyond the hymen.
* Have lower urinary tract pathology in the form of a fistula or diverticulum.
* Have a malignancy or with a history of malignancy within the past 5 years, except for a basal cell carcinoma that has been treated with local excision and is no longer present.
* Are on anticoagulant therapy.
* Have received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment.
* Are deemed by the investigator as medically unfit for surgery or who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the GYNECARE TVT SECUR System IFU.
* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.

Primary outcomes:
measure: Clinical performance of TVT-SECUR*
timeFrame: Screening and Day 35
Secondary outcomes:
measure: Assessment of the results of the standing cough stress test
timeFrame: Screening, Week 5, Months 6 and 12
measure: Intra- and post-operative complications
timeFrame: Intraoperative, Week 5, Months 6 and 12
measure: Physician questionnaire results
timeFrame: Months 2 and 12
measure: Urodynamics
timeFrame: Screening, Week 5, Months 6 and 12 (post-operative optional)
measure: QoL measures
timeFrame: Screening, Week 5, Months 6 and 12
measure: Subject satisfaction.
timeFrame: Month 12
measure: Anesthesia
timeFrame: intraoperative
measure: Operative time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Michigan Institute of Women's Health
state: Michigan
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Padova
country: Italy
facility: University of Padova
Study officials:
affiliation: Ethicon, Inc.
name: David Robinson, MD
role: STUDY_DIRECTOR
References: