To assess the safety and performance of the CytaCoat Foley catheter through a randomized, controlled trial with two parallel groups.

Assessing the safety and performance of the novel CytaCoat Foley catheter: A prospective randomized controlled study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086528

Enrollment

Registered

2025-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: N30-N39- Other diseases of the urinary system

Interventions

Intervention1: CytaCoat Foley catheter: The CytaCoat catheter is a flexible silicone tube with an inflatable balloon on its tip with one drainage funnel, one inflation access port at the proximal end

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults, male and female, aged 18 to 84 years 2.Subjects in need of a urinary catheter for a minimum of 72 hours 3.Subjects who can accommodate a size of 14, 16 and 18 French Foley catheter 4.Written informed consent 5.Subject to be conscious

Exclusion criteria

Exclusion criteria: 1.Pregnant or breastfeeding women 2.Critically ill subjects with a life-threatening disorder (Subjects having an APACHE II score greater equal 28) 3.Subject with a known silicone allergy or sensitivity 4.Previous enrolment in the present study 5.Simultaneous participation in another clinical study that may impact the primary endpoint 6.Subject with pre-existing urinary catheter for more than 48 hours 7.Subject with symptomatic genitourinary pathology 8.Expected severe non-compliance to the protocol as judged by the principal investigator

Design outcomes

Primary

Measure	Time frame
Adverse events (AEs) and serious adverse events (SAEs) are further divided into adverse device effects (ADEs) and serious ADEs (SADEs).Timepoint: 1.Minimum of 72 hours 2.Maximum of 14 days of catheter use 3.Telephonic follow-up 7 1 days of catheter removal.	—

Secondary

Measure	Time frame
The secondary endpoint assesses the overall performance related to the medical device, based on Foley catheter usability experience by the healthcare personnel and subjects: 1. Assessment of usability of the Foley catheter by a responsible nurse/physician with the NRS scale (0-10) using a questionnaire. 2. Assessment immediately after removal of the catheter of pain, irritation, and discomfort measured with the NRS scale (0-10) using a questionnaire asking subjects about their experience using the catheter. 3. Telephonic follow-up assessment between 7 1 days after removal of the catheter using a questionnaire asking subjects about their experience using the catheter.Timepoint: 1.Minimum of 72 hours 2.Maximum of 14 days of catheter use 3.Telephonic follow-up 7 1 days of catheter removal.	—

Measure

Time frame

The secondary endpoint assesses the overall performance related to the medical device, based on Foley catheter usability experience by the healthcare personnel and subjects: 1. Assessment of usability of the Foley catheter by a responsible nurse/physician with the NRS scale (0-10) using a questionnaire. 2. Assessment immediately after removal of the catheter of pain, irritation, and discomfort measured with the NRS scale (0-10) using a questionnaire asking subjects about their experience using the catheter. 3. Telephonic follow-up assessment between 7 1 days after removal of the catheter using a questionnaire asking subjects about their experience using the catheter.Timepoint: 1.Minimum of 72 hours 2.Maximum of 14 days of catheter use 3.Telephonic follow-up 7 1 days of catheter removal.

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Countries

India

Contacts

Public ContactDr Soumya Madhusudhan

St.Johns Medical College Hospital

soumyadnb@gmail.com8301856818

Outcome results

None listed

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