What side effects are associated with this type of intervention?

Common treatments for urinary retention, such as alpha-blockers and anticholinergics, have several known side effects. Alpha-blockers can cause dizziness, headache, fatigue, and orthostatic hypotension. Anticholinergics may lead to dry mouth, constipation, blurred vision, and cognitive impairment. Sugammadex, used for reversing neuromuscular blockade, is generally well-tolerated but can cause side effects like nausea, vomiting, hypotension, and allergic reactions. Glycopyrrolate/neostigmine, used for similar purposes, can cause bradycardia, dry mouth, and gastrointestinal disturbances.

What prior FDA approvals exist?

Sugammadex is an FDA-approved drug specifically designed to encapsulate and reverse the effects of certain neuromuscular blocking agents like rocuronium and vecuronium, which are used during surgical procedures. This drug works by binding to these agents, thereby reversing their muscle-relaxing effects and facilitating the return of normal muscle function, which can help in reducing postoperative urinary retention. Other treatments for urinary retention may include alpha-adrenergic antagonists and 5-alpha reductase inhibitors, but these do not function in the same way as Sugammadex.

What other types of research exist?

Promising alternatives to Sugammadex for urinary retention patients could include the use of glycopyrrolate/neostigmine combination for reversing neuromuscular blockade. Additionally, non-pharmacological methods like percutaneous tibial nerve stimulation may also be considered for managing urinary retention.

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Selective Relaxant Binding Agent

Sugammadex for Postoperative Urinary Retention

Q: What is the mechanism of action of this treatment?

Sugammadex works by encapsulating neuromuscular blocking agents, reversing their effects, and aiding in the recovery of normal muscle function, including those involved in urination. This is particularly important for urinary retention patients as it helps restore bladder control post-surgery. Other common treatments include anticholinergic agents, which relax the bladder muscle, and alpha-blockers, which relax the muscles in the prostate and bladder neck, facilitating easier urination. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the underlying cause of urinary retention.

Phase 1 & 2

Recruiting

Led By Omar Duenas Garcia, MD

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients undergoing a vaginal hysterectomy with the indications of pelvic organ prolapse or abnormal uterine bleeding

Be older than 18 years old

Must not have

Patients undergoing a conventional laparoscopic or robotic approach

Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 hours postop

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods for reversing muscle relaxation during surgery. One method acts like a magnet to remove muscle relaxants, while the other helps the body naturally counteract muscle relaxation. The study focuses on patients having a total vaginal hysterectomy with or without additional pelvic procedures.

Who is the study for?

This trial is for female patients having a vaginal hysterectomy due to pelvic organ prolapse or abnormal bleeding. It excludes those with voiding issues, severe kidney problems, risk of malignant hyperthermia, allergies to study drugs or anesthesia meds, recent participation in other trials, pregnancy, and certain surgical approaches.

What is being tested?

The study tests Sugammadex against a standard glycopyrrolate/neostigmine combo during surgery under general anesthesia. It's randomized and double-blinded; neither the doctors nor the patients know who gets which treatment until after the study.

What are the potential side effects?

Sugammadex may cause side effects like allergic reactions or changes in heart rate. The usual combination of glycopyrrolate/neostigmine can also have side effects including dry mouth, blurred vision, and difficulty urinating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman having a hysterectomy for prolapse or abnormal bleeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My surgery will be done using a laparoscopic or robotic method.

Select...

I am on dialysis or have severe kidney problems.

Select...

I will take toremifene around the same time as the study medication.

Select...

I do not wish to participate in the study.

Select...

I cannot take certain drugs used in this study due to allergies or side effects.

Select...

I or someone in my family has had malignant hyperthermia.

Select...

I am having a sling procedure along with my vaginal hysterectomy.

Select...

I cannot have certain muscle relaxant reversal drugs after surgery due to my condition or past surgery.

Select...

I am a male.

Select...

I am allergic or might be allergic to the study drug, painkillers, muscle relaxants, or anesthesia medications.

Select...

I do not have any health conditions that would prevent me from taking the study medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 hours postop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 hours postop

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 hours postop for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Void Test (Fail)

Void Test (Pass)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard of CareActive Control1 Intervention

Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg)

Group II: SugammadexActive Control1 Intervention

Sugammadex dose=4 mg x kg

0 / 12Eligibility 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

Sugammadex works by encapsulating neuromuscular blocking agents, reversing their effects, and aiding in the recovery of normal muscle function, including those involved in urination. This is particularly important for urinary retention patients as it helps restore bladder control post-surgery. Other common treatments include anticholinergic agents, which relax the bladder muscle, and alpha-blockers, which relax the muscles in the prostate and bladder neck, facilitating easier urination. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the underlying cause of urinary retention.

Effect of distigmine combined with propiverine on bladder activity in rats with spinal cord injury.