A Randomized Controlled Trial of Use Versus Non-use of Bladder Catheterization in Elective Cesarean Delivery
Phase: NA
Conditions: Cesarean Section Complications
Sponsor: University of Calgary

Research Protocol 
 
Ethics ID: REB24-0044 
Study Title: Use versus non-use of bladder catheterization in uncomplicated cesarean delivery  
PI: Wood, Nelson 
Version 1.0 -  January 23, 2024 
 
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A Randomized Controlled Trial of use versus non-use of bladder catheterization in elective  
cesarean delivery 
 
 
Investigators 
 
Dr. Stephen Wood, MD FRCP Obstetrics and Gynecology - Principal Investigator  
 
Dr. Gregg Nelson, MD, PhD, FRCSC Obstetrics and Gynecology, Gynecologic Oncology - Principal 
Investigator 
 
Dr. Amy Metcalfe, PhD - Department of Obstetrics and Gynecology - Co-investigator 
 
Dr. Rebecca Carrigan, MD PGY-3 Obstetrics and Gynecology - Resident 
 
 
 
Background 
 
Delivery by Cesarean section (CS) is one of the most commonly performed surgeries in the world. 
Advantages of CS are well described, however it is a major surgery that presents complications 
including those involving the urinary system. Currently it is common practice to place an indwelling 
bladder catheter prior to CS. Although the current recommendation published in the ERAS guideline is 
to remove indwelling catheters immediately post operatively, it is typical that they are left in for 
upwards of 24 hours (1). Indwelling foley catheters are associated with higher rates of urinary tract 
infection (UTI), post-operative pain, and prolonged postoperative hospitalization (2). There is evidence 
to suggest that omitting the use of indwelling catheters during CS could reduce these risks which could 
significantly benefit patients in their post-partum recovery (3).  
 
A Cochrane review completed in 2014 on this subject included only three randomized controlled trials 
comparing use versus non-use of indwelling bladder catheter in CS. UTI was significantly reduced in 
non-catheterized groups in both studies who assessed for bacteriuria (3,4). In one study, patient 
ambulation, first postoperative voiding time, and duration in hospital were all significantly less in the 
non-catheterized group, however this study had significant heterogeneity in their groups particularly 
involving regional versus general anesthetic (3). A common reason for routine bladder catheterization 
is the idea that it reduces bladder injury by increasing visualization of the lower uterine segment, 
however interestingly there were no bladder injuries described across evaluated studies in the non-
catheterized groups (3,4,5). So far, limitations mainly in methodology and sample size in previous 
work have made it difficult to provide sound clinical recommendations when it comes to non-use of 
routine bladder catheterization. Our hope is to conduct a randomized controlled trial at the Foothills 

Research Protocol 
 
Ethics ID: REB24-0044 
Study Title: Use versus non-use of bladder catheterization in uncomplicated cesarean delivery  
PI: Wood, Nelson 
Version 1.0 -  January 23, 2024 
 
2 
 
 
Medical Centre that focuses on sound methodology and clear outcomes to build on the existing 
evidence on this topic.  
 
Primary Research Question 
 
To investigate the impact of routine bladder catheterization in uncomplicated CS on hospitalization 
time (readiness to discharge), time to ambulation, urinary retention, development of UTI, prevention of 
bladder injury, operating time, and patient satisfaction. 
 
Study Design 
 
This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit 
at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients 
awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical 
triage by a trained nurse research assistant. Participants would be randomized into either a catheterized 
or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured 
by using either a central computer generator for randomization if funding permits, otherwise sealed, 
opaque, and sequenced envelopes will be used. Since we anticipate potential differences in patients 
with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in 
treatment groups.  
 
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has 
been administered. It would be removed at 12 hours post CS by postpartum nursing staff. Participants 
in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the 
operating room where they will undergo surgery without an indwelling catheter. If there is an 
intraoperative decision to place an indwelling catheter, the reason for doing so will be recorded on the 
post-operative survey described below. Due to the nature of this study design, blinding of either party is 
not feasible. Inclusion criteria are women who are 18 years of age or older with a singleton pregnancy 
presenting for an elective primary or repeat CS. Exclusion criteria include diagnosis of abnormal 
placentation including placenta previa, vasa previa, or suspected invasive disease.  
 
The primary outcome will be time at readiness for discharge post-surgery. Secondary outcomes will 
include time to ambulation, incidence of urinary retention, incidence of UTI requiring antibiotics in the 
first 4 weeks postpartum, incidence of bladder injury in surgery, operating time, and patient satisfaction 
as measured by the Maternal Satisfaction for Caesarean Section questionnaire (MSCS).   
 
Urinary retention will be defined based on a patient's inability to spontaneously void requiring either -
and-out catheterization or placement of an indwelling catheter during the postoperative course. The 
data for postoperative time at readiness for discharge as well as ambulation time will be collected via a 
form that will be distributed to the postpartum nursing team. It will be important to ensure that the time 
at clinical readiness for discharge be recorded, as there are many variables (such as waiting on 
prescriptions) that could act as confounders to the actual time to discharge.  The operating surgeon will 
provide data on intraoperative observations and complications. This will be collected via an electronic 
post-operative questionnaire using free software such as Qualtrics. This will be used to identify 

Research Protocol 
 
Ethics ID: REB24-0044 
Study Title: Use versus non-use of bladder catheterization in uncomplicated cesarean delivery  
PI: Wood, Nelson 
Version 1.0 -  January 23, 2024 
 
3 
 
 
intraoperative difficulties and complications such as bladder injury, bladder distension, difficulty with 
hysterotomy or bladder avoidance during surgery, and the clinical decision to place indwelling catheter 
either intraoperatively or immediately postoperatively. If the surgeon decides at any point during the 
surgery to place an indwelling catheter, intention to treat analysis will be upheld and those participants 
will to be analyzed according to their original group. 
 
The MSCS is a validated 22-item questionnaire developed initially as an efficient tool for evaluating 
maternal satisfaction in women undergoing CS under regional anesthesia (6). This will also include a 
visual analogue scale (VAS) for simple maternal satisfaction.  This scale was recommended in a large 
comparative review published in BMC as a short option for patient satisfaction specific to maternity 
care with high reliability, and good construct validity. This will be completed by the patient prior to 
discharge  
 
Statistical Analysis 
 
The primary outcomes are  hospitalization time, time to ambulation, urinary retention, development of 
UTI, prevention of bladder injury, and patient satisfaction. For many of these baseline estimates for a 
sample size calculation are not available. However, based on data from FMC the average length of stay 
post CS is 2.1 days. Converting this to hours and assuming a power of 80% and setting alpha at .05 a 
sample 30 subjects would provide 80% power to detect a 50% difference in length of stay. A sample of 
128 would have adequate power to detect a difference in LOS of 25%. We aim to recruit 140 
individuals. Currently FMC performs between 62-100 elective CS per month (2022-march 23 data).  
Therefore, with even a modest recruitment rate we should easily recruit sufficient patients. Time to 
discharge, time to ambulation and patient satisfaction (VAR) will be analysed with a comparison of 
means after appropriate transformations. A t-test will be used to assess statistical significance. Bivariate 
data such as urinary retention, UTI and bladder injury will be described as rates and statistical 
significance assessed with a Fisher’s exact test. 
 
Risks and Benefits 
 
The benefits of the proposed study are the gathering of information that could help guide clinical 
practice with regards to the use of bladder catheterization in uncomplicated cesarean delivery. While 
evidence exists, there are significant issues with methodology that make the results difficult to 
interpret. Based on previous literature, the largest risk to participants is the need for intraoperative 
catheterization based on the surgeon's discretion after abdominal entry. Precaution to maintain a sterile 
environment in this case would be taken.  
 
 
 
 

Research Protocol 
 
Ethics ID: REB24-0044 
Study Title: Use versus non-use of bladder catheterization in uncomplicated cesarean delivery  
PI: Wood, Nelson 
Version 1.0 -  January 23, 2024 
 
4 
 
 
References 
1. Macones GA, Caughey AB, Wood SL, et al. Guidelines for postoperative care in cesarean de- 
livery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3). Am J 
Obstet Gynecol 2019;221:247.e1-9.  
2. Villar J, Carroli G, Zavaleta N, et al. Maternal and neonatal individual risks and benefits 
associated with caesarean delivery: multicentre prospective study. BMJ. 2007;335(7628):1025.  
3. Nasr, A., ElBigawy, A., Abdelamid, A. et al. Evaluation of the use vs nonuse of urinary 
catheterization during cesarean delivery: a prospective, multicenter, randomized controlled 
trial. J Perinatol 29, 416–421 (2009). https://doi-org.ezproxy.lib.ucalgary.ca/10.1038/jp.2009.4 
4. Acharya S, Uprety DK, Pokharel HP, Amatya R, Rai R. Cesarean Section without Urethral 
Catheterization: A Randomized Control Trial. Kathmandu Univ Med J 2012;38(2):18-22.  
5. Ghoreishi J. Indwelling urinary catheters in cesarean delivery. Int J Gynaecol Obstet 
2003;83(3): 267–270.  
6. Morgan PJ, Halpern S, Lo, J. The development of a maternal satisfaction scale for caesarean 
section. International Journal of Obstetric Anesthesia 1999;8(3):165-70