A Prospective, Multi-centre Study to Evaluate the Clinical Performance of TVTO-PA as Treatment for Stress Urinary Incontinence - TVTO_PA

Johnson & Johnson0 sites100 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

•1\. Subjects with demonstrable SUI diagnosed by CST, suitable for surgical repair.
•2\. Age \>\<\=18 years.
•3\. Agrees to participate in the study, including completion of all study\-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent.
•4\. Post\-void residual volume \<100ml as determined prior to the SCST

•1\. Previous surgical treatment for SUI.
•2\. Requirement for any concurrent gynecological procedures.
•3\. Associated pelvic organ prolapse (either symptomatic and/or leading edge \>0cm)
•4\. Exhibits a clinical history of predominantly OAB symptoms.
•5\. Current anti\-cholinergic use.
•6\. Experimental drug or experimental medical device within 3 months prior to the planned procedure.
•7\. Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
•8\. Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
•9\. History of pelvic radiation.
•10\. Systemic disease known to affect bladder or bowel function (e.g. Parkinson\*s disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).