Indwelling vs Intermittent Catheterization Pilot Study

Summary

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.

Conditions

• Urogenital
• Urinary Tract Infections
• Hip Fractures
• Catheter Complications

Interventions

DEVICE

Indwelling Catheter

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.

DEVICE

Intermittent Catheterization

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.

Sponsors & Collaborators

• The Ottawa Hospital

  collaborator OTHER

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• George Grammatopoulos, MD · The Ottawa Hospital

• Steven Papp, MD · The Ottawa Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2023-05-31

Completion

2023-07-31

Countries

• Canada

Study Locations