Effect of Indwelling Foley Placement, Immediate Post-Operative Straight Catheterization, or No Catheterization on Post-operative Urinary Retention After Transforaminal Lumbar Interbody Fusions
Phase: NA
Conditions: Transforaminal Lumbar Interbody Fusion
Sponsor: Rush University Medical Center

Protocol Title: 
NCT04645264 
Date:   May 12, 2021 
Effect of Indwelling Foley Placement, Immediate Post-Operative Straight 
Catheterization,or No Catheterization on Post-operative Urinary Retention After 
Transforaminal Lumbar Interbody Fusions

Version Date: 01/14/2020 
 
Study Proposal 
 
 
Title: Effect of Indwelling Foley Placement, Immediate Post-Operative Straight Catheterization, 
or No Catheterization on Post-operative Urinary Retention After Transforaminal Lumbar 
Interbody Fusions 
Principal Investigator: 
Kern Singh, MD  
Co-Investigator:              Matthew Colman, MD 
Study Coordinator: 
Mukesh Ahuja  
 
 
1) BACKGROUND 
 
Post-operative urinary retention (POUR) is one the most common post-operative complications 
after elective spine surgeries. Common causes of POUR include bladder stenosis, distension, 
trauma due to catheterizations, age, and prostate hyperplasia.5 The incidence of POUR increases 
with age, gender, types of surgery conducted, any comorbidities such as cerebral palsy or 
multiple sclerosis, use of drugs such as anticholinergic agents, beta blockers, or 
sympathomimetics, and use of IV fluids.5 This condition has been associated with the 
development of UTIs and sepsis, increased post-operative length of stay (LOS), and 90-day 
readmission after surgery. In the field of spine surgery, the reported incidence of POUR is highly 
variable, and there is no consensus on effective methods of prevention. 
 
2) PURPOSE 
 
To determine if indwelling Foley placement at the onset of the procedure, straight catherization 
at the conclusion of the procedure, or no catheterization whatsoever produces the lowest rates of 
POUR after transforaminal lumbar interbody fusions (TLIFs). 
 
3) HYPOTHESIS 
 
We hypothesize that neither intraoperative indwelling Foley placement nor immediate post- 
operative straight catherization will reduce the incidence of POUR in patients who undergo TLIF 
surgical procedures. 

Version Date: 01/14/2020 
 
4) STUDY QUESTIONS 
 
a) Is there a difference in risk of POUR or other complications when using either an 
indwelling Foley catheter, immediate post-operative straight catheterization, or no 
catheterization during TLIF spinal surgeries? 
b) Is there a difference in hospital length of stay when using either an indwelling Foley 
catheter, immediate post-operative straight catheterization, or no catheterization during 
TLIF spinal surgeries? 
 
5) METHEDOLOGY 
a) Study Design 
a. Prospective randomized controlled trial 
b. Group 1: Indwelling Foley catheterization 
i. Placed in the operating room immediately prior to the TLIF procedure and 
removed the following morning 
c. Group 2: Straight catheterization 
i. In-and-out straight catheterization that will take place at the conclusion of 
case before extubation 
d. Group 3: No catheterization during TLIF surgery 
b) Study Population 
a. Single-level TLIF patients 
i. Patients scheduled to undergo a primary single-level TLIF procedure for 
degenerative conditions will be asked to participate in the study. Potential 
subjects will meet with a research coordinator to discuss the details of the 
study. Those who choose to participate will be consented accordingly. 
ii. Inclusion criteria 
1. Patients undergoing a primary single-level TLIF 
a. Diagnosis: radiculopathy, stenosis, herniated nucleus 
pulposus, degenerative disc disease, spondylosis, 
osteophytic complexes, spondylolysis, spondylolisthesis 
2. Patients able to provide informed consent 
 
iii. Exclusion criteria 
1. Patients with baseline urinary dysfunction requiring manual 
bladder emptying via intermittent straight catheterization, 
suprapubic catheters, or other indwelling catheters. 
2. Allergies or other contraindications to medicines in the post- 
operative urinary retention protocol 
3. Lack of consent 
iv. A priori analysis was conducted using the limited available data and we 
have established a sample size of 40 in each cohort will be sufficient in 
order to identify a difference between cohorts. Kiddoo et al. had study 
design comparing hydrophilic coated versus polyvinylchloride catheters in 
preventing urinary tract infections and used a sample size close to 100 

Version Date: 01/14/2020 
 
patients. Of the 120 patients screens 97 were ultimately included in the 
study. As such, our prospective study will require a similar sample size. 
 
 
c) Data collection: 
a. The institution’s post-operative urinary retention protocol (attached) will be 
followed for all patients and relevant events and values recorded in the electronic 
medical record as is standard institutional practice. 
b. Data Collection & Record Keeping: Data will be recorded from electronic 
medical records and survey studies as previously listed. Information will be 
imported into an excel sheet and maintained in reports included in supplemental 
documentation. As stated above patient identifiable information (name, MRN, 
DOB, etc) will be utilized to collect data on the correct patient. Variables 
collected will be as listed in the study design. After all data has been collected 
patients will be assigned a study serial number in the excel sheet and de-identified. 
EPIC and NextGen will be accessed from MOR and collected directly from the 
patient’s charts. All information regarding the nature of the proposed 
investigation provided to the investigator (with the exception of information 
required by law or regulations to be disclosed to the IRB, the subject, or the 
appropriate regulatory authority) will be kept in confidence by the investigator. 
All personal information will be treated as strictly confidential and not made 
publicly available. All records and appendices are stored in separate locked filling 
cabinets as well as a password protected computer which are accessed only by the 
Principal Investigator and Study Coordinators. All identifiable data will be 
destroyed a year after the study is complete. 
c. Data Privacy & Confidentiality: As stated previously all data will be collected 
directly from the electronic medical records, survey results as previously listed. 
Information will be imported into an excel sheet. Once all data has been collected 
patients will be de-identified and provided a database serial number. This serial 
number will be used to merge files and ensure the data is not mixed up between 
patients. All data will be recorded and accessed from a password-protected 
computer at MOR, to which only the study personnel have access. 
 
6) OUTCOMES 
a) Primary 
a. Ability to spontaneously urinate 
b. Post-void (or attempted void if allotted time for spontaneous void elapsed) 
residual volumes as measured via bedside bladder scanner 
c. Need for straight catheterization or post-operative indwelling Foley catheter 
placement 
d. Initiation of an alpha-1 inhibitor post-operatively 
e. Urologic consultations for evaluation of post-operative urinary complications 
f. Number of patients who were discharged with indwelling Foley catheter or clean 
intermittent catheterization 
g. UTI acquired post-operatively 
h. Length of hospital stay 

Version Date: 01/14/2020 
 
i. The number of hours of hospitalization from entering the recovery room 
(time zero) until patient meets discharge criteria. 
 
b) Secondary 
a. General health status 
(i) Patients will be asked to complete the Short Form-12 Survey (SF-12) for 
general health status questionnaire prior to surgery at their preoperative 
office visit or just prior to surgery in the preoperative waiting area. In the 
post-operative period, patients will be asked to complete the Short Form- 
12 Survey for general health status questionnaire at the follow up office 
visits. 
(ii) Pain Visual Analog Scale (VAS) questionnaire 
(iii)Oswestry Disability Index (ODI) questionnaire 
(iv)Patient-Reported Outcomes Measurement Information System (PROMIS) 
questionnaire 
 
b. Narcotic consumption 
i. The total amount of narcotic use for each subject will be recorded. 
Dosages of narcotics will be converted to morphine equivalents. This 
information will be measured during the hospitalization. 
c. Post-operative complications 
i. Post-operative nausea and vomiting 
1. Any patient complaining of nausea who receives and anti-emetic 
will be considered to have PONV. The medication, dose and 
number of times administered will be obtained from the hospital 
record. 
ii. Venous thromboembolic events 
1. Patients with a positive venous ultrasound were considered to have 
a venous thromboembolism. 
iii. Ileus 
1. Any patient who requires placement of a nasogastric tube or fails 
to pass flatus by post-operative day three will be considered to 
have an ileus. 
iv. Respiratory depression/airway compromise 
1. Oxygen saturation <88% 
2. Respiratory rate <8 in medical record vital signs 
3. Post-operative re-intubation or prolonged (>48 hours intubation) 
v. Renal Insufficiency 
1. Increase in creatinine by 0.5 mg/dL from baseline 
vi. Wound Complication 
1. Surgical site infection 
2. Wound dehiscence 
 
7) Covariates Measured 
A) Demographic 
a. Age, Sex, Ethnicity, Body Mass Index (BMI), Insurance 

Version Date: 01/14/2020 
 
B) Comorbidities 
C) Smoking Status 
D) Duration of spinal symptoms 
E) Previous spinal surgery (other than lumbar spine surgery) 
F) Intraoperative variables 
a. Surgeon 
b. Operative time 
c. Estimated blood loss 
d. Anesthesia used 
e. Unilateral versus bilateral instrumentation 
 
8) Statistical Analysis 
 
Demographic and baseline variables will be presented utilizing descriptive statistics (mean with 
standard deviation, median with interquartile range and proportions). Due to randomization, any 
differences in the study cohorts will be due to chance alone (p<0.05). 
 
Normally distributed outcomes will be compared between the treatment groups utilizing an 
unpaired t test with ANOVA for repeated measures. Mann-Whitney test will be used for those 
outcome variables, which are not normally distributed. Binomial outcomes will be compared 
between treatment groups utilizing Chi square testing. Confidence intervals (95%) and p values 
will be reported where appropriate. 
 
Sources: 
1) Golubovsky JL, Ilyas H, Chen J, Tanenbaum JE, Mroz TE, Steinmetz MP. Risk factors 
and associated complications for postoperative urinary retention after lumbar surgery for 
lumbar spinal stenosis. Spine J. 2018; 
2) Martin MA, Kane C. Nursing considerations in the use of cidofovir for CMV retinitis in 
patients with AIDS: report of a roundtable meeting. J Assoc Nurses AIDS Care. 
1997;8(5):66-74. 
3) Altschul D, Kobets A, Nakhla J, et al. Postoperative urinary retention in patients 
undergoing elective spinal surgery. J Neurosurg Spine. 2017;26(2):229-234. 
4) Hoke N, Bradway C. A Clinical Nurse Specialist-Directed Initiative to Reduce 
Postoperative Urinary Retention in Spinal Surgery Patients. Am J Nurs. 2016;116(8):47- 
52. 
5) Darrah DM, Griebling TL, Silverstein JH. Postoperative urinary retention. Anesthesiol 
Clin. 2009;27(3):465-84, table of contents. 
6) Kiddoo, D et al. Randomized Crossover Trial of Single Use Hydrophilic Coated vs 
Multiple Use Polyvinylchloride Catheters for Intermittent Catheterization to Determine 
Incidence of Urinary Infection. The Journal of Urology. 2015;194(1):174-179.