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Sugammadex for Postoperative Urinary Retention (POUR Trial)
Phase 3
Recruiting
Led By Brant T Heniford, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing laparoscopic inguinal hernia repair at Carolinas Medical Center by attending surgeons within the Division of Gastrointestinal and Minimally Invasive Surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at discharge (up to 365 days)
Awards & highlights
POUR Trial Summary
This trialwill compare how well two drugs prevent urinary retention after surgery.
Who is the study for?
This trial is for adults over 18 who are having laparoscopic inguinal hernia repair at Carolinas Medical Center and agree to participate. It's not for those with end-stage renal disease, neuromuscular diseases, concurrent major surgeries, or past bad reactions to Sugammadex.Check my eligibility
What is being tested?
The POUR Study is testing whether Sugammadex reduces the rate of urinary retention after surgery compared to traditional reversal agents in patients undergoing laparoscopic inguinal hernia repair.See study design
What are the potential side effects?
Sugammadex may cause side effects such as allergic reactions, changes in heart rhythm, bleeding issues, and potential mild symptoms like nausea or headache. The exact side effects will be monitored throughout the study.
POUR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having laparoscopic inguinal hernia repair at Carolinas Medical Center.
POUR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at discharge (up to 365 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at discharge (up to 365 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with urinary retention
Secondary outcome measures
Hospital Cost
Length of stay (Days)
Quality of life - Carolinas Comfort Scale
POUR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SugammadexExperimental Treatment1 Intervention
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.
Group II: Retrospective cohortActive Control1 Intervention
Retrospective cohort of patients who did not receive Sugammadex
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
2017
Completed Phase 4
~3410
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,097 Total Patients Enrolled
2 Trials studying Urinary Retention
13 Patients Enrolled for Urinary Retention
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,864 Total Patients Enrolled
1 Trials studying Urinary Retention
118 Patients Enrolled for Urinary Retention
Brant T Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
143 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to participate in the study.I am having a hernia repair at the same time as another surgery.I have a neuromuscular disease.I am having laparoscopic inguinal hernia repair at Carolinas Medical Center.You have had bad reactions to Sugammadex before.My kidneys are in end-stage failure.I am over 18 years old.I am having surgery for a hernia in my groin area, and possibly my belly button.
Research Study Groups:
This trial has the following groups:- Group 1: Sugammadex
- Group 2: Retrospective cohort
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being accepted into this research project?
"The information available on clinicaltrials.gov does show that this study is looking for willing participants. The study was originally posted on April 13th, 2022 and updated as recently as October 28th, 2022. Currently, there is a goal to enroll 140 patients at a single site."
Answered by AI
What are the government regulations surrounding Sugammadex?
"This medication has received a score of 3 from our team at Power, meaning that it is considered safe. This is because Sugammadex is a Phase 3 trial, which means that there is some data supporting its efficacy and multiple rounds of data supporting its safety."
Answered by AI
Are there any volunteers still needed for this experiment?
"Yes, this is accurate. The clinical trial in question is still looking for participants, as can be seen on clinicaltrials.gov. The trial was first posted on April 13th, 2022 and was last updated on October 28th, 2022."
Answered by AI
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