Evaluating the Gynecare TVT EXACT® Continence System for treating urinary incontinence in women
A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence
This study is testing if the Gynecare TVT EXACT® Continence System can help women with stress urinary incontinence feel better after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 195 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Ethicon, Inc. Industry-sponsored |
| Locations | 8 sites (Durham, North Carolina and 7 other locations) |
| Trial ID | NCT04829994 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance of the Gynecare TVT EXACT® Continence System in women who are undergoing surgery for stress urinary incontinence (SUI). It involves a single-arm approach where participants will be monitored post-surgery to evaluate the effectiveness of the mid-urethral sling. The study focuses on women aged 21 and older who have been diagnosed with SUI and are seeking surgical correction without additional prolapse procedures. Participants will be required to provide informed consent and attend follow-up visits to track their outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 and older with confirmed stress urinary incontinence who are planning to undergo surgery using a synthetic pubo-urethral vaginal sling.
Not a fit: Patients with physical or psychological conditions that impair their ability to participate in the study or complete required follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for women suffering from stress urinary incontinence.
How similar studies have performed: Other studies evaluating mid-urethral sling systems have shown promising results, indicating that this approach is supported by prior successful outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 1. Stress urinary incontinence symptoms 2. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test 3. Female subjects ≥ 21 years of age requiring treatment of SUI 4. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling 5. Planned surgery for primary stress incontinence without concomitant prolapse surgery 6. Patient able and willing to participate in follow-up 7. Subject or authorized representative has signed the approved informed consent Exclusion Criteria: Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: 1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires 2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product 3. History of previous synthetic, biologic or fascial pubo-urethral sling 4. Pregnancy or plans for future pregnancy 5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice. 6. Current genitourinary fistula or urethral diverticulum 7. Reversible cause of incontinence (i.e. drug effect) 8. Contraindication to surgery
Where this trial is running
Durham, North Carolina and 7 other locations
- Duke University — Durham, North Carolina, United States (Recruiting)
- Institute for Female Pelvic Medicine — North Wales, Pennsylvania, United States (Recruiting)
- Upmc — Pittsburgh, Pennsylvania, United States (Recruiting)
- Ordensklinikum Linz — Linz, Austria (Recruiting)
- Herlev Hospital — Hillerod, Denmark (Recruiting)
- Hopital Jeanne de Flandres — Lille, France (Recruiting)
- Universitatsklinikum Tubingen — Tubingen, Germany (Recruiting)
- Karolinska Institute — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Christine Romanowski
- Email: cromanow@its.jnj.com
- Phone: 908-808-6219
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.