A Clinical Study to Evaluate the Performance and Safety of the Incontinence Management Device â??Contisphere Â®â?? in Women with Urinary Stress Incontinence

Blue Neem Medical Devices Pvt Ltd0 sites0 target enrollmentStarted: TBDLast updated: January 9, 2023

Trial Snapshot

No summary available.

•1- Female Patient is 18 years or older
•2- Patient has a diagnosis of Grade II or III urinary stress incontinence, or intrinsic sphincteric
•deficiency proven by a positive provocative stress test or Patient (with mixed incontinence) in
•whom the bladder instability finding is not prominent
•3- Patient has positive pad weight test (urine loss within 1 hour ï?³ 2 g)
•4- Patient is a failure of surgical treatment and/or refuses surgical intervention
•5- Patient uses appropriate contraception or is post-menopausal
•6- Patient is willing to comply with study requirements
•7- Patient is capable of giving informed consent

•1-Patient (with mixed incontinence) in whom the bladder instability finding is prominent
•2- Patient has an active urinary tract infection or has had 2 diagnosed urinary tract infections in the
•past 6 months
•3- Patient has hematuria that has not been previously evaluated and treated
•4- Patientâ??s status is compromised by interstitial cystitis, severe diabetes, neurogenic bladder,
•bladder cancer, urethral structures and/or significant genital prolapse
•5- Patient is carrying a pacemaker
•6- Patient does suffer from reduced bladder sensation
•7- Patient is pregnant (pregnancy must be ruled out by a pregnancy test for patients of childbearing
•8- Patient has bladder tumors or stones
•9- Patient is taking medication that has an effect on continence

Sponsor

Blue Neem Medical Devices Pvt Ltd