The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).
Study Type
OBSERVATIONAL
Enrollment
198
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 subjects would receive as part of SOC.
Duke University
Durham, North Carolina, United States
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Ordensklinikum Linz
Linz, Austria
Cough Stress Test (CST) Assessment Change
Objective cure of Stress Urinary Incontinence (SUI) (treatment success) sproximately 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, approximately 10 yrs completion
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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Herlev Hospital
Hillerød, Denmark
Hopital Jeanne de Flandres
Lille, France
Universitatsklinikum Tubingen
Tübingen, Germany
Karolinska Institute
Stockholm, Sweden