Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
ConditionStress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorEthicon, Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intervention
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov