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

Johnson & Johnson0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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).
•11. Nursing, pregnant or intends future pregnancy.
•12. In the investigator*s opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.

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