The POUR (Postoperative Urinary Retention) Study

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05276804
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 140
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.6
• Patients Per Site Per Month: 30.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Urinary Retention	Drug: Sugammadex	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary Retention (POUR) Following Laparoscopic Inguinal Hernia Repair
• Actual Study Start Date: Apr 13, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of participants with urinary retention [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 Outcome Measures

1. Length of stay (Days) [From post up to discharge (up to 365 days)]

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

2. Hospital Cost [At discharge (up to 365 days)]

   Patient costs associated with procedure and hospital stay

3. Quality of life - Carolinas Comfort Scale [Postop clinic visit (typically 1-2 weeks post surgery)]

   Score range 0-115 . Lower scores indicate more favorable health

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolinas Medical Center	Charlotte	North Carolina	United States	28204

Sponsors and Collaborators

• Wake Forest University Health Sciences
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Brant T Heniford, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 9, 2021

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT05276804
• Other Study ID Numbers: IRB00083113; 01-22-45E
• First Posted: Mar 11, 2022
• Last Update Posted: Apr 29, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Wake Forest University Health Sciences: Sugammadex
• Additional relevant MeSH terms: Urinary Retention

Study Results

No Results Posted as of Apr 29, 2022