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).
Study Type
OBSERVATIONAL
Enrollment
195
There 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.
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States
RECRUITINGBio-Medical University Rome
Rome, Italy
RECRUITINGOspedale San Pietro Fatebenefratelli
Rome, Italy
RECRUITINGCough 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 yrs
Patient Global Impression of Improvement (PGI-I)
Time frame: Post-surgery through study completion, approximately 10 yrs
International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline and post-surgery through study completion, approximately 10 yrs
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: Baseline and post-surgery through study completion, approximately 10 yrs
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 yrs
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Ospedale Regionale Beata Vergine
Mendrisio, Switzerland
RECRUITING