The POUR (Postoperative Urinary Retention) Study (POUR)

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Urinary Retention
• Intervention / Treatment: Drug: Sugammadex

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugammadex; Prospective cohort of patients undergoing laparoscopic inguinal hernia repair will receive Sugammadex. Sugammadex will be used for reversal of their neuromuscular blockade. 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.	Drug: Sugammadex; 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.
No Intervention: Retrospective cohort; Retrospective cohort of patients who did not receive Sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Urinary Retention	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	6 hours postop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Cost	Patient costs associated with procedure and hospital stay	At discharge (up to 365 days)
Length of Stay (Days)	Patients will be followed from post surgery until discharge to determine the interim time	From post op to discharge (up to 365 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Survey	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.	Week 2
Operation Time	Number of minutes the operation lasted	Day 1
Morphine Milligram Equivalents	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.	Day 1
Number of Participants With Clean Wounds at Follow Up	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.	Up to Week 2

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Brant T Heniford, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Sugammadex
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention
• Other Study ID Numbers: IRB00083113; 01-22-45E (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes