Health Condition 1: N394- Other specified urinary incontinence
Conditions
Interventions
Intervention1: Nelaton Catheter (FG-6 (Sea Green), 8 (Light Blue), 10 (Black), 12 (White), 14 (Green), 16 (Orange), 18 (Red), 20 (Yellow), 22 (Violet), 24 (Blue)).: Short Term Use- Less than 60 minute
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and Females (Adults & Paediatrics) who are expected to require Nelaton Catheter (Nel Cath). 2.Subject who can provide Informed Consent Form (Adult) in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) can provide Informed Assent Form (Child). 3.The subject is willing and able to comply with the requirement of the follow-up. OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who is willing and able to comply with the requirement of the follow-up.
Exclusion criteria
Exclusion criteria: 1.Subject who present with medical emergency, where treatment is more priority than the informed consent/informed assent process. 2.Subject with a history of urethral stricture, undergone trans-urethral resection of the prostate gland in the previous 48 hours, subject with phimosis, undiagnosed hematuria, urinary tract infection with clinical symptoms, dysuria due to urethral stricture, etc. 3.Subject, who cannot provide Informed Consent Form (Adult) such as unconscious, mentally challenged subject, OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission etc. 4.Any known allergy with any of the material of Nelaton Catheter (Nel Cath) and its component(s). 5.Other conditions, which in the opinion of investigator make the subject unsuitable for enrolment or could, interfere with his/her participation in, and completion of the clinical investigation plan. 6.Subject who is pregnant or breast feeding. 7.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 8.Participation in another research study involving an active investigation within 30 days prior to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful Completion of Performance TimelineTimepoint: Short Term Use- less than 60 minutes to more than 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed