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
This trial does not accept healthy volunteersQualifiers
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 population
Female subjects ≥ 21 years of age with a diagnosis of SUI, resulting from urethral hypermobility and/or intrinsic sphincter deficiency
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intervention
DeviceThere is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures the subjects would receive as part of SOC.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Cough Stress Test (CST) Assessment Change
Objective cure of Stress Urinary Incontinence (SUI) (treatment success) approximately 5-10 years after surgery, defined as a negative CST
Time frame
Post-surgery through study completion, approximately 5-10 yrsSecondary outcomes
1
Patient Global Impression of Improvement (PGI-I)
Time frame
Post-surgery through study completion, approximately 10 yrs2
International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame
Baseline and post-surgery through study completion, approximately 10 yrs3
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame
Baseline and post-surgery through study completion, approximately 10 yrs4
Wong-Baker FACES® Pain Rating Scale
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to study device or procedure.
Time frame
Post-surgery through study completion, approximately 10 yrsSponsors and contacts
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Source ClinicalTrials.gov