Health Condition 1: N393- Stress incontinence (female) (male)
Conditions
Interventions
Intervention1: Contisphere ®: The ContiSphere System is an intravesical device intended for women diagnosed with grade II or grade
III SUI. It is designed for single use. This device is classified a
Sponsors
Blue Neem Medical Devices Pvt Ltd
Eligibility
Inclusion 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
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 potential) 8- Patient has bladder tumors or stones 9- Patient is taking medication that has an effect on continence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To use 0 to 1 absorbent pad per day less than 7 pads per week valuated for the indwelling period of day 1 of ContiSphere insertion to Day 90 No de-novo UTI during its indwelling periodTimepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Successful and safe insertion and retrieval of ContiSphere Balloon 2. Less patient discomfort during insertion and retrieval of ContiSphere Balloon as feedback 3. Less patient discomfort while ContiSphere Balloon in bladder as feedback 4. To use 0-1 absorbent pad per day for 90 days of continuous use 5. Adverse events induced by the ContiSphere Balloon or its accessories 6. QOL Timepoint: 1 day for successful and safe insertion and discomfort at insertion time feedback and 90 days for other outcomes. | — |
Countries
India
Contacts
Public ContactSubham Dutta
Blue Neem Medical Devices
Outcome results
None listed