Health Condition 1: N394- Other specified urinary incontinence
Conditions
Interventions
Intervention1: Self
Adhesive Silicone Male External Catheter (SMEC): The product is an accessory intended to channel urine from the penis to
extension tubing and urinary collection bags for adult mal
Sponsors
CEPHAS MEDICAL PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male above age of 18 years with urinary incontinence who require an effective and secure method for urine collection. 2.Men who are either active and able to self-manage catheter use (community users/self-users), have assistance from a caregiver (home users with nursing care), or are under physician supervision in a hospital setting (hospital users). 3.Men with healthy, undamaged skin on the penis, free from any wounds, rashes or infections. 4.Men who are not sensitive or allergic to silicone or skin-safe adhesives. 5.Men who do not require an indwelling catheter, as this device is designed for external use only. 6.Men seeking a non-invasive solution who prefer a more comfortable alternative to an internal catheter.
Exclusion criteria
Exclusion criteria: 1.Men with a very short or retracted penis where the catheter may struggle to remain securely in place. 2.Men with dermatological conditions such as sores, rashes, swelling, or infections on the penis, which may compromise the effectiveness of the catheter. 3.Men with known sensitivities or allergies to silicone or medical adhesive products, which may lead to adverse reactions. 4.Men who experience heavy perspiration or swelling in the genital area, potentially hindering the catheter s ability to adhere securely. 5.Men with reduced sensation in the genital area (e.g., due to nerve damage), who may be unable to detect discomfort or complications. 6.Men requiring constant or high-volume urine drainage, as this catheter type may not be suitable for managing large fluid volumes consistently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To confirm the performance and gather user feedback on the modified solvent-based adhesive in Self-Adhesive SMEC, among male users from diverse backgrounds in India, including individuals with physical disabilities, elderly users, and those with active lifestyles.Timepoint: Every 24 hours for 6 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the clinical safety and overall effectiveness of the Cephas Silicone Male External Catheter in managing urinary incontinence.Timepoint: Every 24 hours for 6 days | — |
Countries
India
Contacts
Public ContactDr N Rajasekar
Sudha Hospitals
Outcome results
None listed