Indwelling vs Intermittent Catheterization Pilot Study

NCT05354921 | Unknown DMC

• 1 other identifier: 20220067-01H
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Safety-Related Outcomes - Rates of UTI

  30 days

• Safety-Related Outcomes - Rates of POUR

  30 days

• patient experience questionnaire

  pre-operatively, and post-operative day six or at discharge

Study Arms (2)

Indwelling

EXPERIMENTAL

Foley catheterization upon admission and removed the morning following surgery.

Device: Indwelling Catheter

Intermittent

EXPERIMENTAL

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

Device: Intermittent Catheterization

Interventions

Indwelling Catheter DEVICE

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.

Indwelling

Intermittent Catheterization DEVICE

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.

Intermittent

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (10)

• Health Quality Ontario, M.o.H.a.L.-T.C., Quality Based Procedures Clinical Handbook for Hip Fracture. 2013.

  BACKGROUND

• Dodd AC, Bulka C, Jahangir A, Mir HR, Obremskey WT, Sethi MK. Predictors of 30-day mortality following hip/pelvis fractures. Orthop Traumatol Surg Res. 2016 Oct;102(6):707-10. doi: 10.1016/j.otsr.2016.05.016. Epub 2016 Aug 3.

  PMID: 27496661 RESULT

• Skelly JM, Guyatt GH, Kalbfleisch R, Singer J, Winter L. Management of urinary retention after surgical repair of hip fracture. CMAJ. 1992 Apr 1;146(7):1185-9.

  PMID: 1555145 RESULT

• Smith NK, Albazzaz MK. A prospective study of urinary retention and risk of death after proximal femoral fracture. Age Ageing. 1996 Mar;25(2):150-4. doi: 10.1093/ageing/25.2.150.

  PMID: 8670545 RESULT

• Hedstrom M, Grondal L, Ahl T. Urinary tract infection in patients with hip fractures. Injury. 1999 Jun;30(5):341-3. doi: 10.1016/s0020-1383(99)00094-7.

  PMID: 10505128 RESULT

• Kamdar A, Yahya A, Thangaraj L. Retrospective observational study of the incidence of short-term indwelling urinary catheters in elderly patients with neck of femur fractures. Geriatr Gerontol Int. 2009 Jun;9(2):131-4. doi: 10.1111/j.1447-0594.2008.00490.x.

  PMID: 19740355 RESULT

• Schneider MA. Prevention of catheter-associated urinary tract infections in patients with hip fractures through education of nurses to specific catheter protocols. Orthop Nurs. 2012 Jan-Feb;31(1):12-8. doi: 10.1097/NOR.0b013e3182419619.

  PMID: 22278644 RESULT

• Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.

  PMID: 20156062 RESULT

• Thomas S, Harris N, Dobransky J, Grammatopoulos G, Gartke K, Liew A, Papp S. Urinary catheter use in patients with hip fracture: Are current guidelines appropriate? A retrospective review. Can J Surg. 2021 Nov 25;64(6):E630-E635. doi: 10.1503/cjs.014620. Print 2021 Nov-Dec.

  PMID: 34824151 RESULT

• Excellence, N.I.f.H.a.C., Hip fracture: management. 2011.

  RESULT

MeSH Terms

Conditions

Urinary Tract Infections; Hip Fractures

Interventions

Catheters, Indwelling; Intermittent Urethral Catheterization

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies; Urinary Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• George Grammatopoulos, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

• Steven Papp, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Horton

CONTACT

613-737-8899; ihorton@ohri.ca

George Grammatopoulos, MD

CONTACT

ggrammatopoulos@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A clinical research coordinator that is blinded to the arm patients are randomized to will be responsible for recording all outcome measures of interest prospectively in the study's database from the patient's electronic medical records.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 2, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)