Indwelling vs Intermittent Catheterization Pilot Study (PEE)

Ottawa Hospital Research Institute

Status: Unknown

Conditions: Hip Fractures; Urinary Tract Infections; Catheter Complications; Urogenital

Treatments: Device: Indwelling Catheter; Device: Intermittent Catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT05354921

20220067-01H

Details and patient eligibility

About

The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization. The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this pilot study trial and proceed towards a multi-center trial.

Full description

The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization.

The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this vanguard trial and proceed towards a multi-center trial.

Secondary objectives would be related to safety and patient activity that would be important endpoints for the definitive, large scale trial. These would include the following:

1. Is short term indwelling catheter use associated with reduced incidence of UTI compared to clean intermittent catheterization in patients with hip fracture.
2. How does patient experience compare between these two forms of treatment?

Eligible patients will be approached for consent at admission and, if willing to participate, will be randomized into Group A or Group B using a web-based, computer-generated randomization with permuted blocks of varying sizes.

Data Collection will include:

• Urinary symptoms at admission, pre-fracture
• Date and time of catheter insertion (indwelling or not)
• Date and time of surgery
• Type of anesthesia used
• Date and time of catheter removal
• Number of catheterizations performed during hospital stay
• Type of Antibiotic cover during per-operative period (typically 3 doses provided perioperatively)

A clinical research coordinator (CRC) will oversee study recruitment and assess number of study participants to the total number of patients admitted with a hip fracture which will allow for documentation of ability to recruit into the study. Furthermore, the CRC will prospectively record each patent's journey to assess whether enrolled patients are receiving the treatment they are randomized to. All enrolled patients will be asked to fill in a patient satisfaction score that has been in use already at our institution.

A CRC, blinded to the arm patients were randomized to, will be responsible for recording all outcome measures of interest prospectively in the study's database from the participant's electronic medical records. Validity of data extraction will be tested for a randomly selected 10% of the cohort by a second evaluator (CRC not previously involved in the study).

Data analyses will include:

Descriptive Statistics: Given the feasibility purpose of the vanguard trial, descriptive statistics will be used to summarize demographics and baseline prognostic factors of participants allocated to the two trial arms.

Analysis of Primary Outcome: Our primary endpoint is the rate of enrolment to ensure the ability to undertake a larger multi-centered trial. An average rate of 10 patients/month or greater will be considered as ideal for establishing feasibility. An enrollment of less than 5 patients/month will likely jeopardize the ability to feasibly recruit for the larger trial. Whereas, average monthly enrolment of 5 to 10 patients will require a re-evaluation of our recruitment strategy, intervention specifications, and/or eligibility criteria to improve enrolment.

Analysis of Secondary Outcomes: Given the vanguard nature of this trial, the investigators will not undertake inferential analyses of our secondary outcomes but rather these patients will be carried forward into the larger trial.

Enrollment: 120 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hip fracture (intertrochanteric, femoral neck, femoral head, sub-trochanteric) confirmed by imaging
• Age ≥50 years
• Operative treatment planned
• Admitted under Orthopaedic Surgery
• Willing and able to sign consent (substitute decision maker)

Exclusion criteria

• Periprosthetic hip fracture
• Polytrauma
• Multiple fractures of the lower limbs
• Previous lower urinary tract surgery
• Known (past or current) urogenital cancer (prostate, bladder)
• Urinary tract infection prior to randomization
• Indwelling catheter present on admission (chronic or placed at previous acute setting)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Indwelling

Experimental group

Description:

Foley catheterization upon admission and removed the morning following surgery.

Treatment:

Device: Indwelling Catheter

Intermittent

Experimental group

Description:

Intermittent catheterization when post-void residual volume is greater than 400 mL.

Treatment:

Device: Intermittent Catheterization