CTRI/2021/04/032834
Recruiting
未知
A Clinical Study to Evaluate the Performance and Safety of the Incontinence Management Device â??Contisphere ®â?? in Women with Urinary Stress Incontinence
Blue Neem Medical Devices Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Blue Neem Medical Devices Pvt Ltd
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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