For Healthcare Professionals

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


About the study

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 take part

You may be eligible to participate in the study if you meet the following 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
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Stress Urinary Incontinence

Age (in years)


Participants needed


Est. Completion Date

Feb 27, 2036

Treatment type



Ethicon, Inc. identifier


Study number


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