Sugammadex for Urinary Retention

Carolinas Medical Center, Charlotte, NC
Urinary RetentionSugammadex - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trialwill compare how well two drugs prevent urinary retention after surgery.

Eligible Conditions
  • Postoperative Urinary Retention

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: At discharge (up to 365 days)

6 hours postop
Number of participants with urinary retention
Day 365
Hospital Cost
Day 365
Length of stay (Days)
Week 2
Quality of life - Carolinas Comfort Scale

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Retrospective cohort
1 of 2
Sugammadex
1 of 2

Active Control

Experimental Treatment

140 Total Participants · 2 Treatment Groups

Primary Treatment: Sugammadex · No Placebo Group · Phase 3

Sugammadex
Drug
Experimental Group · 1 Intervention: Sugammadex · Intervention Types: Drug
Retrospective cohortNoIntervention Group · 1 Intervention: Retrospective cohort · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sugammadex
2017
Completed Phase 4
~3410

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at discharge (up to 365 days)

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,733 Previous Clinical Trials
4,973,284 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,172 Previous Clinical Trials
1,057,952 Total Patients Enrolled
2 Trials studying Urinary Retention
13 Patients Enrolled for Urinary Retention
Brant T Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
143 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.