Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention

NCT05643950 | Withdrawn DMC

• 2 other identifiers: RM-TCONTROL-2022-012022-002862-34
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention.

Conditions

Urinary Retention; Catheter-Associated Urinary Tract Infection; Catheter Complications

Keywords

Catheterisation; T-Control; Urinary catheter; Foley catheter

Outcome Measures

Primary Outcomes (1)

• Magnitude of infections

  The magnitude of infection will be obtained from the analysis of urine culture samples taken from participants

  Day 14 after inclusion (follow-up visit)

Secondary Outcomes (8)

• Rate of symptomatic and asymptomatic infections

  Day 14 after inclusion (follow-up visit)

• Self-perceived health-related quality of life (HRQoL)

  Day 14 after inclusion (follow-up visit)

• Indication of antibiotic treatments

  Day 14 after inclusion (follow-up visit)

• Determination of the biofilm formed in the catheters

  Day 14 after inclusion (follow-up visit)

• Number of adverse events related to catheterization

  Day 14 after inclusion (follow-up visit)

Study Arms (2)

Control arm (Foley catheter)

ACTIVE COMPARATOR

When randomly allocated to this arm, a conventional Foley-type catheter will be inserted during all the study period (2 weeks). At day 14 after inclusion, the patient will be called for a follow-up visit to remove the catheter.

Device: Foley catheter

T-Control arm

EXPERIMENTAL

When randomly allocated to this arm, the T-Control catheter will be inserted during all the study period (2 weeks). At day 14 after inclusion, the patient will be called for a follow-up visit to remove the catheter.

Device: T-Control catheter

Interventions

Foley catheter DEVICE

Silicone Foley catheters are transurethral balloon catheters used for the treatment of bladder emptying disorders, as well as for drainage of urine from the urinary tract, continuous fluid irrigation, and/or medication administration. Its use is suitable for a prolonged period of no more than 29 days and is used in Urology, Internal Medicine, Surgery, Obstetrics and Gynaecology Services. For this study, conventional Foley-type catheters whose use is approved in Spain for routine use will be used. Silicone Foley catheters, usually available in 2- and 3-way, are made of silicone and consist of a body, drainage funnel, inflation funnel, irrigation funnel (if present, only on 3-way catheters) and balloon valve. The product is sterile and single use.

Control arm (Foley catheter)

T-Control catheter DEVICE

The T-control® catheter is a flexible, sterile silicone tube with an inflatable balloon at the distal tip, a polytetrafluroethylene membrane integrated into its body, and a sliding fluid control valve. The valve, built into the catheter, provides additional functions to the catheter, such as turning urine flow on and off after insertion (functions currently provided by accessories such as caps or valves) and controlling urination during the insertion process (function that is not provided by any other device). In this way, accidental loss of urine can be avoided from the first moment of use until its withdrawal. Additionally, it has a safety cap that reduces the possibility of accidental movements of the valve before use or during transport and fixing. The design has been developed in such a way that, once inserted, it facilitates autonomous use even for the elderly or patients with limited manual dexterity. The device is sterile and single use, like any conventional Foley catheter.

T-Control arm

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with Acute Urine Retention
• Equal or over 50 years of age
• Indication of bladder catheterization for 2 weeks
• Maintained cognitive and physical capacity for self-monitoring the catheter valve
• Signed consent agreement

You may not qualify if:

• Current or recent urinary tract infection in the last 2 weeks
• Use of current treatment/antibiotic in the last 2 weeks
• Immunocompromised patients (diagnosed with advance cancer, Acquired Immunodeficiency Syndrome,...)
• Catheter insertion requiring more than 1 attempt
• Overactive bladder
• Patients with bilateral obstructive uropathy

Sponsors & Collaborators

• Rethink Medical SL: lead

Study Sites (2)

Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Laura Vera, Dr.

  Hospital Universitario Insular de Gran Canaria

  PRINCIPAL INVESTIGATOR

• Adrián Amador, Dr.

  University Hospital of the Nuestra Señora de Candelaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analysis will be blinded to the intervention arm as well as the laboratories that will carry out the analysis of the urine and catheter samples.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 9, 2022
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 2 months after publication.
• Access Criteria: Review requests and criteria for reviewing requests will be carried out by the Principal Investigators and Sponsor.

Locations

ES (2)