What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for urinary retention, such as alpha-1-adrenergic antagonists (e.g., tamsulosin, alfuzosin) and antimuscarinic agents (e.g., oxybutynin, solifenacin), have known side effects. Alpha-1-adrenergic antagonists can cause dizziness, headache, fatigue, and orthostatic hypotension. Antimuscarinic agents may lead to dry mouth, constipation, blurred vision, and cognitive dysfunction. Sugammadex, used for reversing neuromuscular blockade, is generally well-tolerated but can cause side effects such as nausea, vomiting, hypotension, and allergic reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for urinary retention, primarily focusing on medications that manage symptoms or underlying causes. Sugammadex, which encapsulates neuromuscular blocking agents, is being studied for its potential to reduce postoperative urinary retention. While specific FDA approvals for drugs exactly like Sugammadex in this context are not detailed, other treatments for urinary retention include alpha-adrenergic antagonists like tamsulosin and 5-alpha reductase inhibitors such as finasteride, which help alleviate symptoms by relaxing the bladder neck and reducing prostate size, respectively.

What other types of research exist?

Promising alternatives to Sugammadex for urinary retention patients include antispasticity drugs like Ba-34647 (Lioresal) and mirabegron, particularly for those with neurogenic bladder. These treatments have shown effectiveness in managing bladder function and reducing residual urine.

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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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at discharge (up to 365 days) for reporting.

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

0 / 4Eligibility criteria met

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.