Clinical study on Contisphere ® device.

Not Applicable

• Conditions: Health Condition 1: N393- Stress incontinence (female) (male)

• Registration Number: CTRI/2021/04/032834
• Lead Sponsor: Blue Neem Medical Devices Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

potential)

8- Patient has bladder tumors or stones

9- Patient is taking medication that has an effect on continence

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To use 0 to 1 absorbent pad per day less than 7 pads per week valuated for the indwelling period of day 1 <br/ ><br>of ContiSphere insertion to Day 90 No de-novo UTI during its indwelling periodTimepoint: 90 days

Secondary Outcome Measures

Name	Time	Method
1.Successful and safe insertion and retrieval of ContiSphere Balloon <br/ ><br>2.Less patient discomfort during insertion and retrieval of ContiSphere Balloon as feedback <br/ ><br>3.Less patient discomfort while ContiSphere Balloon in bladder as feedback <br/ ><br>4.To use 0-1 absorbent pad per day for 90 days of continuous use <br/ ><br>5. Adverse events induced by the ContiSphere Balloon or its accessories <br/ ><br>6. QOL <br/ ><br>Timepoint: 1 day for successful and safe insertion and discomfort at insertion time feedback and 90 days for other outcomes.