A Study of 100% Silicone Foley Balloon Catheter

A prospective, observational and multi-center study to characterize the safety, efficacy and performance of the 100% SILICONE FOLEY BALLOON CATHETER (2-WAY & 3-WAY)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/04/042015

Enrollment

Registered

2022-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: N394- Other specified urinary incontinence

Interventions

Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: -All subjects who undergo urinary catheterization. -Both Male and Female patients will be enrolled. -Patients who have been treated with 100% SILICONE FOLEY BALLOON CATHETER (2WAY & 3-WAY) -All patients who are willing to provide informed consent for participation in the study -Pediatric population using silicone foley catheter

Exclusion criteria

Exclusion criteria: -Subjects not suitable for intervention with 100% SILICONE FOLEY BALLOON CATHETER (2-WAY & 3-WAY). -All subjects who are not willing to provide informed consent for participation in the study

Design outcomes

Primary

Measure	Time frame
To demonstrate clinical safety and efficacy of the 100% Silicone Foley Balloon Catheter (2 Way / 3Way) and to observe any undesirable events under normal condition of use.Timepoint: 6 Months	—

Secondary

Measure	Time frame
To demonstrate the performance of 100% Silicone Foley Balloon Catheter (2 Way / 3Way)Timepoint: 6 Months	—

Countries

India

Contacts

Public ContactDr C R Chandrashekara

Anesthesiologist, Sagar hospitals

drcrc2014@gmail.com9845001061

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026