TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00463554
First received: April 18, 2007
Last updated: January 26, 2009
Last verified: January 2009

April 18, 2007
January 26, 2009
April 2006
January 2007   (final data collection date for primary outcome measure)
Clinical performance of TVT-SECUR* [ Time Frame: Screening and Day 35 ] [ Designated as safety issue: No ]
Clinical performance of TVT-SECUR*
Complete list of historical versions of study NCT00463554 on ClinicalTrials.gov Archive Site
  • Assessment of the results of the standing cough stress test [ Time Frame: Screening, Week 5, Months 6 and 12 ] [ Designated as safety issue: No ]
  • Intra- and post-operative complications [ Time Frame: Intraoperative, Week 5, Months 6 and 12 ] [ Designated as safety issue: Yes ]
  • Physician questionnaire results [ Time Frame: Months 2 and 12 ] [ Designated as safety issue: No ]
  • Urodynamics [ Time Frame: Screening, Week 5, Months 6 and 12 (post-operative optional) ] [ Designated as safety issue: No ]
  • QoL measures [ Time Frame: Screening, Week 5, Months 6 and 12 ] [ Designated as safety issue: No ]
  • Subject satisfaction. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Anesthesia [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • Operative time [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Assessment of the results of the standing cough stress test
  • intra- and post-operative complications
  • Anesthesia
  • Operative time
  • Physician questionnaire results
  • Pre-operative urodynamics (post-operative optional)
  • QoL measures
  • Subject satisfaction.
Not Provided
Not Provided
 
TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence
An Evaluation of the GYNECARE TVT-SECUR* System (Tension-Free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women with stress urinary incontinence

Stress Urinary Incontinence
Device: GYNECARE TVT-SECUR* System
A sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency
Other Name: Sub-urethral sling
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2007
January 2007   (final data collection date for primary outcome measure)

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.
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Finland,   Italy
 
NCT00463554
300-05-002
No
Judith Gauld, BSc (Hons), Ethicon Inc.
Ethicon, Inc.
Not Provided
Study Director: David Robinson, MD Ethicon, Inc.
Ethicon, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP