FindTrial
Sign In

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

A prospective, interventional, and multi-center study to characterize the efficacy and performance of the 100% Silicone Foley Balloon Catheter 2-way, 100% Silicone Foley Balloon Catheter ? BH model 2-way, and 100% Silicone Foley Balloon Catheter ? Star/ Ribbed model 2-way - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061801
Enrollment
30
Registered
2024-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: 1. 100% Silicone Foley Balloon Catheter (2-way without cap) [SMD 552] 2. 100% Silicone Foley Balloon Catheter ? BH model (2-way with cap) [SMD 517] 3. 100% Silicone Foley Balloon Cathet

Sponsors

Sterimed Group
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. 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

MeasureTime frame
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. A telephonic follow-up of subjects will be done after a week of catheter removal.—

Countries

India

Contacts

Public ContactDr K S Shiva Kumar

Amar Jyothi Nursing Home and PMP Medical Centre

drksshivakumar@yahoo.com9480311799

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026