Study to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter 2-way

Not Applicable

• Conditions: Health Condition 1: N00-N99- Diseases of the genitourinary system

• Registration Number: CTRI/2024/01/061801
• Lead Sponsor: Sterimed Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.All subjects who undergo urinary catheterization indicated for long term catheterization of minimum of 30 days

2.Both Male and Female patients will be enrolled

3.All patients who are willing to provide informed consent for participation in the study

Exclusion Criteria

1.Subjects not suitable for intervention with silicone Foley catheter

2.All subjects who are not willing to provide informed consent for participation in the study

3.Pediatric population

4.Neurogenic bladder condition subjects

5.Immobilized subjects

6.Subjects having urethral strictures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Secondary Endpoint is to evaluate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star or Ribbed model and BH model. <br/ ><br>To determine the activation of periurethral gland The physical verification by the investigator via ease of removal and ease of reinsertion of next catheter (if any). The investigator will rate the catheter based on VAS score based on user experience and patient comfort.Timepoint: A minimum of 30 days after catheterization the activation of periurethral gland of the product will be assessed.

Secondary Outcome Measures

Name	Time	Method
To demonstrate the activation of periurethral gland is maintained during the catheter use and post catheterization by comparing the Star model and BH model.Timepoint: Duration of study is 4 months. <br/ ><br>A telephonic follow-up of subjects will be done after a week of catheter removal.