Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

Launched by ETHICON, INC. · Mar 31, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the Gynecare TVT ABBREVO® Continence System, which is a treatment for women suffering from stress urinary incontinence (SUI). SUI is when activities like coughing, sneezing, or exercising cause urine to leak. The goal of the study is to evaluate how well this system works in helping women who are planning to have surgery to address their SUI. The trial is currently recruiting female participants aged 21 and older who have been diagnosed with SUI and are seeking surgical treatment without needing any additional surgeries at the same time.

To participate, women must have symptoms of SUI confirmed by a specific test and be willing to follow up after the surgery. However, certain conditions could make someone ineligible, such as having had previous surgeries for incontinence, being pregnant, or having other health issues that could affect their participation. If eligible, participants can expect to undergo the planned surgery and will be asked to attend follow-up visits to monitor their progress and the effectiveness of the treatment. This study aims to provide valuable information about the TVT ABBREVO® system to help improve care for women with SUI.

Gender

FEMALE

Eligibility 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. Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
• • 3. Female subjects ≥ 21 years of age requiring treatment of SUI
• • 4. Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
• • 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 sub-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