NCT04829357 · Ethicon, Inc.
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
What this study is about
The objective of this single treatment group$1, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
View original scientific description
The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- Stress urinary incontinence symptoms
- Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
- Female subjects ≥ 21 years of age requiring treatment of SUI
- Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
- Planned surgery for primary stress incontinence without concomitant prolapse surgery
- Patient able and willing to participate in follow-up
- 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:
- 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
- Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
- History of previous synthetic, biologic or fascial sub-urethral sling
- Pregnancy or plans for future pregnancy
- History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
- Current genitourinary fistula or urethral diverticulum
- Reversible cause of incontinence (i.e. drug effect)
- Contraindication to surgery
Where
- North Wales, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations