Mar 11, 2026
Continuous versus intermittent bladder catheterization in epiduralized laboring patients: protocol for a feasibility pilot randomized controlled trial
- Elena Lands1,
- Nicole Meckes2,
- Kai Holder3,
- Jess Sciuva3,
- Lauren Giugale2,
- Anna Binstock1
- 1UPMC Department of Obstetrics and Gynecology, Maternal-Fetal Medicine;
- 2UPMC Department of Obstetrics and Gynecology, Urogynecology;
- 3UPMC Department of Obstetrics and Gynecology
Protocol Citation: Elena Lands, Nicole Meckes, Kai Holder, Jess Sciuva, Lauren Giugale, Anna Binstock 2026. Continuous versus intermittent bladder catheterization in epiduralized laboring patients: protocol for a feasibility pilot randomized controlled trial . protocols.io https://dx.doi.org/10.17504/protocols.io.x54v9be1ql3e/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: December 17, 2025
Last Modified: March 11, 2026
Protocol Integer ID: 235270
Keywords: randomized controlled trial, RCT, urinary retention, postpartum, labor, epidural anesthesia, continuous versus intermittent bladder catheterization, intermittent bladder catheterization, postpartum urinary retention, effects of catheterization method, catheterization method, symptomatic urinary tract infection, voiding dysfunction, laboring patient, pyelonephritis
Funders Acknowledgements:
UPMC Medical Staff Grant
UPMC Volunteer Services Board
Steve N. Caritis Obstetrical Research Grant
Disclaimer
The protocol was approved by the Institutional Review Board. The trial was registered with ClinicalTrials.gov with identifier NCT07125326. Internal institutional funding was utilized. The authors have no relevant financial conflicts of interest.
Abstract
The aims of the P-PURE Trial are to (1) evaluate the effect of continuous versus intermittent bladder catheterization on postpartum urinary retention (primary outcome, hypothesized to decrease) and symptomatic urinary tract infection or pyelonephritis (hypothesized to decrease), (2) estimate the effects of catheterization method on longer term voiding dysfunction, and (3) compare patient and nurse satisfaction for the two methods.
Troubleshooting
Population
English-speaking adult individuals with term singleton living pregnancies admitted to the labor and delivery unit planning a vaginal delivery were identified. Individuals were not eligible for the study if they had a scheduled external cephalic version or cesarean, had a history of neurogenic bladder or overactive bladder symptoms or were performing bladder catheterization prior to admission.
Interventions
Nursing staff on the labor and postpartum units were educated by research staff regarding the existing protocol for bladder management during labor and postpartum. Following written informed consent and neuraxial anesthesia placement, patients received either an indwelling bladder catheter or were catheterized according to the established unit protocol. If patients had a first void of less than 150cc or if they had not voided after 6 hours, unit staff completed a bladder scan assessment of bladder volume. If the patient failed to void >150cc and has a bladder scan volume greater than or equal to 300cc, placement of an indwelling catheter was performed. At 24 hours after catheter replacement, we completed a retrograde voiding trial in which 300cc are instilled into the bladder, the catheter is removed, and if >200cc are voided within thirty minutes, the catheter was replaced.
FoleyCath Protocol diagram.pdf996KB
FoleyCath Protocol diagram.pdf996KB Maternal and neonatal outcomes were abstracted from medical records by research staff greater than six weeks following birth. The investigator making the diagnosis of postpartum urinary retention was blinded to the exposure group. Finally, participants were contacted after 2 and 6 weeks postpartum via secure messaging through the electronic medical record to complete the UDI-6 questionnaire to assess for voiding dysfunction. This tool has previously been applied to the postpartum population.
Outcomes
The primary outcome was feasibility of a randomized control trial to assess the effect of intermittent versus continuous bladder catheterization after epidural placement on rates of postpartum urinary retention. This includes feasibility of recruitment and retention, patient acceptability, and fidelity to the protocol including data collection and study procedure adherence. To assess effectiveness of randomization, demographic and clinical characteristics were compared between groups.
The primary efficacy outcome was urinary retention within three days postpartum, defined as either inability to void spontaneously at six hours after catheter removal or last catheterization, or a PVR greater than 150cc, as defined by the most recent urogynecology data. Factors which were previously proven to influence PUR including delivery type, lacerations, anesthesia dose, neonatal birthweight, and estimated blood loss were collected.
Secondary outcomes included persistent PUR past three days or symptomatic urinary tract infection (UTI) or pyelonephritis within one week postpartum. Patients were excluded from UTI analyses if they received antibiotics intrapartum or had bacteriuria diagnosed by a clean catch specimen showing >100,000 CFU/mL of a single bacterial species regardless of symptoms.
Patient-reported urinary symptoms at two and six weeks postpartum were also assessed with the UDI-6 questionnaire. Patient and nurse satisfaction scores were collected. Rates of adherence to the existing guidelines for intermittent catheterization frequency were examined.
Statistical Analysis
Analyses of the outcomes described above were performed based on the intent-to-treat principle. The primary outcome and the other categorical variables were compared across groups using the chi-squared and Fisher’s exact test. Categorical outcomes were compared using relative risks and 95% confidence intervals. Normally distributed variables were compared using the unpaired t-tests. If variables were not normally distributed, the Mann-Whitney U test was used to compare groups. No imputation was indicated as no primary outcome data were missing. A 2-tailed p >0.05 was considered to indicated statistical significance. Statistical analyses were performed using SPSS.
Protocol references
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