Design, methods and rationale for the prevention of postpartum urinary retention study: protocol of a randomized controlled trial
DOI:
https://doi.org/10.18203/2349-3259.ijct20261385Keywords:
Postpartum urinary retention, Neuraxial anesthesia, Bladder catheterization, Randomized controlled trial, LaborAbstract
Background: Intrapartum bladder overdistension after neuraxial anesthesia can lead to postpartum urinary retention (PUR) as well as long-term voiding dysfunction. This has not yet been assessed as the primary outcome of a randomized controlled trial.
Methods: Patients in labor planning vaginal delivery will be randomized to continuous (CC) versus intermittent catheterization (IC) after receiving neuraxial anesthesia. The primary outcome is urinary retention within three days postpartum, and prespecified secondary outcomes include voiding dysfunction at 2 and 6 weeks via the UDI-6 questionnaire, positive urine cultures within 2 weeks, and patient and nurse satisfaction. We will explain the rationale, review recruitment and screening processes, and describe the interventions, outcome assessments, and planned statistical analyses.
Conclusions: A feasibility trial of ten percent of the planned study population was performed with excellent recruitment and follow-up retention rates. Reasons for protocol deviation were examined and the protocol adjusted as described. Participants of the larger trial will be randomized between December 2025 and May 2026 with final data collection to occur in May 2026. Analyses and submission of results are planned for winter 2026. The prevention of postpartum urinary retention (P-PURE) trial will provide evidence on how bladder catheterization method affects postpartum urinary retention to guide intrapartum catheterization practices.
Trial Registration: Clinicaltrials.gov NCT07125326.
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