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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
Must not have
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)
Neuromuscular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at discharge (up to 365 days)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing whether Sugammadex can help patients urinate more easily after hernia surgery. Sugammadex helps patients wake up from anesthesia faster by reversing muscle relaxants. The study aims to see if it reduces urinary problems and costs without affecting quality of life.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am having a hernia repair at the same time as another surgery.
Select...
I have a neuromuscular disease.
Select...
My kidneys are in end-stage failure.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with urinary retention
Secondary study objectives
Hospital Cost
Length of stay (Days)
Quality of life - Carolinas Comfort Scale
Awards & Highlights
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.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for urinary retention include alpha-blockers, which relax the muscles in the bladder neck and prostate to improve urine flow, and anticholinergics, which reduce bladder muscle contractions to prevent involuntary urination. Cholinesterase inhibitors can enhance bladder muscle activity by increasing acetylcholine levels.
Sugammadex, used in the trial, encapsulates and inactivates neuromuscular blocking agents, reversing muscle relaxation. This is relevant for urinary retention patients as it can help restore normal bladder function postoperatively by reversing the effects of muscle relaxants used during surgery.
Effect of distigmine combined with propiverine on bladder activity in rats with spinal cord injury.Qualitative and quantitative expression profile of muscarinic receptors in human urothelium and detrusor.
Effect of distigmine combined with propiverine on bladder activity in rats with spinal cord injury.Qualitative and quantitative expression profile of muscarinic receptors in human urothelium and detrusor.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,392 Previous Clinical Trials
2,452,715 Total Patients Enrolled
2 Trials studying Urinary Retention
13 Patients Enrolled for Urinary Retention
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,298 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.
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