TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence
This study has been completed.
Information provided by:
First received: April 18, 2007
Last updated: January 26, 2009
Last verified: January 2009
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).
Stress Urinary Incontinence
Device: GYNECARE TVT-SECUR* System
||Observational Model: Cohort
Time Perspective: Prospective
||An Evaluation of the GYNECARE TVT-SECUR* System (Tension-Free Support for Incontinence) for the Treatment of Stress Urinary Incontinence *Trademark
Primary Outcome Measures:
- Clinical performance of TVT-SECUR* [ Time Frame: Screening and Day 35 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2007 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Women with stress urinary incontinence
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463554
|Michigan Institute of Women's Health
|Dearborn, Michigan, United States, 48124 |
|Good Samaritan Hospital
|Cincinnati, Ohio, United States, 45220-2489 |
|The Institute for Female Pelvic Medicine and Reconstructive Surgery
|Allentown, Pennsylvania, United States, 18104 |
|Nashville, Tennessee, United States, 37232 |
|Helsinki University Central Hospital
|Helsinki, Finland, 00028 |
|University of Padova
|Padova, Italy, 35128 |
||David Robinson, MD
No publications provided
||Judith Gauld, BSc (Hons), Ethicon Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 18, 2007
||January 26, 2009
||United States: Institutional Review Board
Italy: Ethics Committee
Finland: Ethics Committee
Keywords provided by Ethicon, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms