Indwelling vs Intermittent Catheterization Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Is short term indwelling catheter use associated with reduced incidence of UTI compared to clean intermittent catheterization in patients with hip fracture. 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.

Official Title
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Hip Fracture Patient and the Use of IndwElling vs IntermittEnt Catheterization Pilot Study

Conditions
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Urogenital, Urinary Tract Infections, Hip Fractures, Catheter Complications

Intervention / Treatment
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* Device: Indwelling Catheter
* Device: Intermittent Catheterization


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indwelling<br>Foley catheterization upon admission and removed the morning following surgery. | Device: Indwelling Catheter<br>* Patients in the experimental group will receive foley catheter upon admission, aseptically. The catheter will be discontinued on the morning following surgery. At TOH most (>75%) hip fractures are treated within 48 hours of admission and 95% within 72 hours and hence the indwelling catheter is likely to stay in place for 3-4 days.<br>|
| Experimental: Intermittent<br>Intermittent catheterization when post-void residual volume is greater than 400 mL. | Device: Intermittent Catheterization<br>* Patients randomized to the intermittent catheterization group will have their PVR monitored every 8 hours pre-operatively. If PVR>400 mL, an intermittent catheter will be used. If PVR> 400 mL greater than 3 times pre-operatively, an indwelling catheter will be placed the fourth time. The indwelling catheter will be removed the morning of post-op day 1. It is expected that a small percentage of patients in either group will not have a PVR>400 mL preoperatively. These patients will not be catheterized but will remain in the study. Post-operatively, both treatment groups will have their PVR monitored for 24 hours, or until PVR is less than 200 mL. If PVR>400 mL and the patient is not able to void further, intermittent catheterization will be done every six hours as needed. If post-operative PVR>400 mL greater than 3 times post-operatively, an indwelling catheter will be placed the fourth time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Feasibility - Enrollment | Number of participants enrolled and willingness of participants to be randomized Comparing the Number of patients screened compared to the number of patients meeting eligibility criteria. Tracking crossover between the treatment groups, participant retention, and follow-up rates. | One year | 
| Study Feasibility - Screening | Number of patients screened and number meeting eligibility | One year | 
| Study Feasibility - Retention | Participant retention rate in study | One year | 
| Study Feasibility - Follow-up | Rates of participant follow-up | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety-Related Outcomes - Rates of UTI | Number of patients who present with a post-operative UTI within 30 days of catheterization | 30 days | 
| Safety-Related Outcomes - Rates of POUR | Number of patients who present with post-operative POUR within 30 days of catheterization | 30 days | 
| patient experience questionnaire | the patient experience questionnaire, created by the principal investigator of the study, will be used to assess patients level of urogenital pain and discomfort and satisfaction with catheterization. | pre-operatively, and post-operative day six or at discharge |