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Completed

NCT Number: NCT05276804

The POUR (Postoperative Urinary Retention) Study

The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents

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Key information

Conditions

Postoperative Urinary Retention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

About this study

Postoperative urinary retention following laparoscopic inguinal hernia repair occurs in approximately one out of ten patients. The more rapid reversal of neuromuscular blockade with Sugammadex has empirically been associated with low rates of postoperative urinary retention. In this study, patients will receive Sugammadex following laparoscopic inguinal hernia repair and then be retrospectively matched against a group of patients who did not receive Sugammadex. The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents (e.g. neostigmine which has a retention rate of 5-11%). We will also examine difference in cost and quality of life between the two groups. Our hypothesis is that the use of Sugammadex will decrease rate of postoperative urinary retention, decrease associated cost, such as need for admission, and not negatively impact quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over the age of 18
  • Undergoing laparoscopic inguinal hernia repair at Carolinas Medical Center by attending surgeons within the Division of Gastrointestinal and Minimally Invasive Surgery
  • Unilateral or bilateral inguinal hernia repair; may have concurrent umbilical hernia repair performed
  • Agreeable to participation in the study

Exclusion criteria

  • Patients who are having concurrent ventral or flank hernias repaired at time of operation or are having an inguinal hernia repair along with another operation (e.g.

laparoscopic cholecystectomy)

  • End-stage renal disease (Creatinine clearance less than 30)
  • Neuromuscular disease
  • Prior adverse reactions to Sugammadex
  • Patients who do not provide consent for the study

Treatment and study plan

Sugammadex

Drug

The dosing for Sugammadex is 4mg/kg for a deep reversal and a 2mg/kg for a standard reversal, which will be more common for this study. Sugammadex comes in 200mg/2mL and 500mg/5mL vials. Because of the variability in weight of the patients and the type of reversal needed (deep vs standard), 140 5mL vials will be required.

Primary outcomes

  1. Number of Participants With Urinary Retention

    Time frame: 6 hours postop

    Urinary retention is defined as the inability to void at six hours postoperatively, which will be recorded in the postoperative recovery area and the same definition for urinary retention will be applied to the comparative retrospective cohort

Secondary outcomes

  1. Length of Stay (Days)

    Time frame: From post op to discharge (up to 365 days)

    Patients will be followed from post surgery until discharge to determine the interim time

  2. Hospital Cost

    Time frame: At discharge (up to 365 days)

    Patient costs associated with procedure and hospital stay

Other outcomes

  1. Quality of Life Survey

    Time frame: Week 2

    Quality of life survey given post hernia repair to evaluate mesh sensation, pain and movement limitations. 23 total items. Each item is scored 0 (no symptoms) to 5 (disabling symptoms). Total score range is 0-115 with a low score indicating surgery had no negative impact on quality of life.

  2. Operation Time

    Time frame: Day 1

    Number of minutes the operation lasted

  3. Morphine Milligram Equivalents

    Time frame: Day 1

    Morphine milligram equivalents (MME) represents the potency of an opioid dose relative to morphine. MME is intended to help clinicians make safe, appropriate decisions concerning changes to opioid regimens.

  4. Number of Participants With Clean Wounds at Follow Up

    Time frame: Up to Week 2

    Number of participants with clean wounds based on the Center for Disease Control and Prevention (CDC) Wound guidelines. CDC wound classification options are Clean, Clean-Contaminated, Contaminated, and Dirty/Infected.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary Retention (POUR) Following Laparoscopic Inguinal Hernia Repair

Acronym: POUR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2022
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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