Sugammadex for Postoperative Urinary Retention

(POUR Trial)

Overseen By Gregory T Scarola, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Wake Forest University Health Sciences

Disqualifiers: End-stage renal disease, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Sugammadex, a medication used during surgery, reduces the risk of postoperative urinary retention compared to traditional drugs. It targets individuals undergoing laparoscopic inguinal hernia repair, a procedure to fix a weakness in the groin area. Ideal candidates are those having this specific surgery at Carolinas Medical Center and willing to participate in the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that Sugammadex is likely to be safe for humans?

Research shows that Sugammadex is usually well-tolerated. Studies have found that Sugammadex greatly lowers the risk of postoperative urinary retention (POUR) without causing major side effects. One study found that patients using Sugammadex had fewer issues with POUR compared to those using traditional drugs. Another study showed no significant effect on postoperative pain or the need to return to the hospital within 30 days. While these results are encouraging, safety can vary from person to person. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for postoperative urinary retention, which often include catheterization or medications like alpha-blockers, Sugammadex stands out due to its unique mechanism of action. Sugammadex works by directly reversing neuromuscular blockade, which can help restore normal bladder function more quickly. Researchers are excited about Sugammadex because it offers a potential quick and targeted approach to address urinary retention, reducing the need for longer-term interventions and enhancing patient recovery after surgery.

What evidence suggests that Sugammadex might be an effective treatment for postoperative urinary retention?

Research has shown that sugammadex can greatly lower the risk of postoperative urinary retention (POUR). In this trial, participants undergoing laparoscopic inguinal hernia repair will receive sugammadex to reverse neuromuscular blockade. Several studies have found that patients who received sugammadex experienced fewer issues with POUR compared to those who used traditional drugs. One review of multiple studies found that sugammadex almost halved the chance of developing POUR. Another study highlighted that sugammadex reduced POUR after minimally invasive inguinal hernia repair. These findings suggest that sugammadex effectively reduces urinary problems after surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Brant T Heniford, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to participate in the study.

I am having laparoscopic inguinal hernia repair at Carolinas Medical Center.

I am over 18 years old.

Exclusion Criteria

I am having a hernia repair at the same time as another surgery.

I have a neuromuscular disease.

You have had bad reactions to Sugammadex before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic inguinal hernia repair and receive either Sugammadex or traditional reversal agents

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for urinary retention and other outcomes in the postoperative recovery area

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for quality of life and hospital costs post-surgery

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sugammadex

Trial Overview 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.

How Is the Trial Designed?

Group I: Sugammadex Experimental Treatment 1 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 cohort Active Control 1 Intervention

Retrospective cohort of patients who did not receive Sugammadex

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

In a study of 3345 patients undergoing inguinal hernia repair, those who received sugammadex for neuromuscular blockade reversal had a significantly lower risk of post-operative urinary retention (POUR) at 1.4%, compared to 4.4% in those treated with anticholinesterase.

Overall, sugammadex was associated with a reduced risk of POUR across various surgical contexts, including open and minimally invasive procedures, as well as unilateral and bilateral repairs, indicating its potential safety advantage in post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of neuromuscular blockade reversal on post-operative urinary retention following inguinal herniorrhaphy. Chau, LC., Jarman, A., Prater, A., et al.[2023]

In a study of 485 patients undergoing laparoscopic or robotic hysterectomy, those who received sugammadex had significantly lower odds of experiencing transient postoperative urinary retention (TPOUR) compared to those treated with a combination of glycopyrrolate and neostigmine (GN).

Patients treated with GN were 1.79 times more likely to be discharged with an indwelling catheter, indicating that sugammadex may be a safer option for neuromuscular reversal in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sugammadex on postoperative urinary retention post-laparoscopic and robotic hysterectomy with and without concomitant procedures. Dueñas-Garcia, OF., Shah, T., Fritts, L., et al.[2023]

Neostigmine significantly improves postoperative urinary retention (POUR) compared to traditional Chinese therapies and physical therapy, with a high odds ratio of 7.47 based on a meta-analysis of 20 trials involving 1,850 patients.

Neostigmine acupoint injection is more effective than intramuscular injection, leading to quicker time to first voiding and better urine excretion, indicating a potentially superior method of administration for treating POUR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of neostigmine for urinary retention after surgeries. Cao, M., Wu, X., Xu, J.[2022]

Organ diseases can significantly affect how neuromuscular blocking and reversal drugs work, leading to increased risks of complications like prolonged muscle paralysis and side effects from medications.

Sugammadex has been highlighted as a safer option for reversing neuromuscular block in patients with various organ diseases, showing promising efficacy and safety in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular blocking drugs and their antagonists in patients with organ disease. Craig, RG., Hunter, JM.[2018]

A retrospective analysis of the FDA's Adverse Event Reporting System revealed a significant association between sugammadex and bronchospasm, with a reporting odds ratio indicating a strong link (PRR = 71.95).

There is also a notable association between sugammadex and coronary arteriospasm, with a significant disproportionality signal (PRR = 43.82), suggesting that healthcare providers should be cautious and monitor for these adverse events when administering sugammadex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of bronchospasm and coronary arteriospasm with sugammadex use: a post marketing analysis. Aggarwal, P.[2022]

In a study of 78 women with urinary retention after urogynecologic surgery, patient satisfaction was similar whether the indwelling catheter was removed at home or in the office, with median satisfaction scores of 95 in both groups.

However, the home catheter removal group experienced significantly fewer urinary tract infections (8.3%) compared to the office group (26.3%), suggesting a potential safety advantage for home removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of patient satisfaction with home vs office indwelling catheter removal placed for urinary retention after female pelvic floor surgery: a randomized controlled trial. Popiel, P., Swallow, C., Choi, JE., et al.[2023]

In a study of 61,898 matched adult inpatients and 95,500 matched adult outpatients, patients who received neostigmine with glycopyrrolate for neuromuscular block reversal experienced a two-fold higher incidence of post-operative urinary retention compared to those reversed with sugammadex (5.0% vs 2.4% inpatients; 0.9% vs 0.4% outpatients).

Multivariable analysis confirmed that using neostigmine was independently associated with a greater risk of post-operative urinary retention, with odds ratios of 2.20 for inpatients and 2.57 for outpatients, indicating a significant safety concern with this reversal method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-operative urinary retention is impacted by neuromuscular block reversal agent choice: A retrospective cohort study in US hospital setting. Bash, LD., Turzhitsky, V., Mark, RJ., et al.[2023]

Sugammadex is an effective agent for reversing neuromuscular blockade by encapsulating rocuronium or vecuronium, allowing for rapid recovery even in severe cases, and it has clinical advantages over traditional agents like neostigmine, including fewer side effects such as nausea and pulmonary complications.

While generally safe, there have been reports of anaphylactoid and allergic reactions to sugammadex, highlighting the need for awareness and management strategies for potential hypersensitivity, especially in pediatric cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic Reactions to Sugammadex: A Case Series and Review of the Literature. Banoub, R., Alalade, E., Bryant, J., et al.[2023]

A case study involving a 57-year-old man revealed that administration of 400 mg of sugammadex after cardiac surgery led to sudden ST elevation and cardiac arrest, highlighting a potential risk associated with its use.

Despite the serious complication, the patient recovered fully after treatment for coronary vasospasm, indicating that while sugammadex is generally safe, clinicians should be vigilant about its possible cardiovascular effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac arrest due to coronary vasospasm after sugammadex administration -a case report. Boo, KY., Park, SH., Park, SK., et al.[2023]

A case study highlighted the potential dangers of using oral distigmine bromide for postoperative urinary retention, as it led to a life-threatening 'cholinergic crisis'.

The literature review concluded that the effectiveness of distigmine bromide for this purpose is unproven, suggesting that its use in postoperative urinary retention is not justified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cholinergic crisis following treatment of postoperative urinary retention with distigmine bromide. Hameed, A., Charles, TJ.[2004]

Sugammadex is a highly effective and safe reversal agent for neuromuscular blocking agents (NMBAs) like rocuronium, significantly reducing the risk of postoperative residual curarization (PORC), which can lead to serious complications such as hypoxemia and pneumonia.

In rapid sequence intubation, using rocuronium followed by sugammadex is more effective and safer than succinylcholine, suggesting that hospitals should prioritize making sugammadex available to enhance patient safety during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do we need to use sugammadex at the end of a general anesthesia to reverse the action of neuromuscular bloking agents? Position Paper on Sugammadex use. Della Rocca, G., Di Marco, P., Beretta, L., et al.[2018]

In a study of 899 patients undergoing lumbar fusion surgery, the use of sugammadex as a reversal agent was found to significantly reduce the risk of postoperative urinary retention (POUR), making it a safer option compared to other agents.

Conversely, the use of succinylcholine during anesthesia was associated with a higher likelihood of developing POUR, with an odds ratio of 4.37, indicating a strong link between this anesthetic agent and urinary retention post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Postoperative Urinary Retention After Lumbar Fusion Surgery: Anesthetics and Surgical Approach. Heard, JC., Lee, Y., Lambrechts, MJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12466067/

The effect of sugammadex on postoperative urinary ... Meta-analysis revealed a significant reduction in the incidence of POUR with sugammadex use (Relative Risk (RR): 0.47, 95% Confidence Interval ( ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839741

Sugammadex for Postoperative Urinary Retention in ... In this study, the use of sugammadex in MIS-IHR was associated with a significant reduction in POUR and LOS. While limited by sample size, no ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0952818023002945

Post-operative urinary retention is impacted by ... Single-institution studies have found decreased incidence of post-operative urinary retention associated with sugammadex reversal. ... Data source and patient ...

4. jheor.org jheor.org/article/121641-economic-impact-of-postoperative-urinary-retention-in-the-us-hospital-setting

Economic Impact of Postoperative Urinary Retention in the ... Furthermore, results from a randomized controlled trial to evaluate efficacy of sugammadex vs neostigmine reported urinary retention only in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12505167/

Sugammadex for Postoperative Urinary Retention in ... In this study, the use of sugammadex in MIS-IHR was associated with a significant reduction in POUR and LOS. While limited by sample size, no ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41013221/

The effect of sugammadex on postoperative urinary ... These findings suggest that sugammadex substantially reduces POUR incidence, with no significant impact on POPS or 30-day readmission rates.