The POUR (Postoperative Urinary Retention) Study

Postoperative Urinary Retention Clinical Trial

— POUR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276804
• Other study ID #: IRB00083113
• Secondary ID: 01-22-45E
• Status: Recruiting
• Phase: Phase 3
• Start date: April 13, 2022
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Brant T Heniford, MD
• Phone: 704-355-3168
• Email: Todd.Heniford[@]AtriumHealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Urinary Retention
• Urinary Retention

Intervention

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.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of stay (Days)	Patients will be followed from post surgery until discharge to determine the interim time	From post up to discharge (up to 365 days)
Secondary	Hospital Cost	Patient costs associated with procedure and hospital stay	At discharge (up to 365 days)
Secondary	Quality of life - Carolinas Comfort Scale	Score range 0-115 . Lower scores indicate more favorable health	Postop clinic visit (typically 1-2 weeks post surgery)