Postoperative Urinary RetentionPhase 1/2NCT05664633
The Role of Sugammadex in Posotoperative Urinary Retention in Patients Undergoing Pelvic Floor Reconstructive Procedures
A Phase 1/2 study testing Sugammadex in people with Postoperative Urinary Retention, run by West Virginia University.
Trial summary
The Investigator will perform a single-institution randomized double-blinded controlled trial comparing intraoperative Sugammadex vs. standard dose of glycopyrrolate/neostigmine combination for participants undergoing a total vaginal hysterectomy with or without pelvic organ prolapse procedures under general… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Urinary Retention
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients undergoing a vaginal hysterectomy with the indications of pelvic organ prolapse or abnormal uterine bleeding
Who cannot join
- Patients who are already known to have voiding dysfunction
- Patients who have a contraindication or intolerance to any of the drugs used in the study
- Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
- Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
- Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min.
- Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.
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- Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.
- Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration.
- Has any condition that would contraindicate the administration of study medication.
- Is pregnant, is attempting to become pregnant, or is lactating.
- Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial.
- Male patients
- Patients undergoing a conventional laparoscopic or robotic approach
- Patients having a midurethral sling in addition to the vaginal hysterectomy
- Patients declining to participate in the study
- Patients allergic to any of the drugs used in the study (sugammadex, neostigmine and/or glycopyrrolate)
About this study
Official title: A Randomized Clinical Trial to Determine the Effect of Transient Postoperative Urinary Retention Using Sugammadex (4 Mg X Kg) Versus Glycopyrrolate and Neostigmine (0.01 Mg/kg - 50mg/kg) in Patients Undergoing Vaginal Hysterectomies with and Without Pelvic Organ Prolapse Procedures: a Pilot Study
The Investigator will perform a single-institution randomized double-blinded controlled trial comparing intraoperative Sugammadex vs. standard dose of glycopyrrolate/neostigmine combination for participants undergoing a total vaginal hysterectomy with or without pelvic organ prolapse procedures under general endotracheal anesthesia.
- Conditions
- Postoperative Urinary Retention
- Being tested
- Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Sugammadex or G/N will be given at the end of the procedure once the surgeon communicates with the anesthesiologist. The surgeon will typically do this at the time of putting the closing sutures.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Active comparator | Sugammadex dose=4 mg x kg Receives: Drug: Sugammadex |
| Standard of Care | No intervention | Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Void Test (Pass)
Number of patients that Pass the Void Test. Once the patients are oriented and before leaving PACU, their bladder will be backfilled with 300 ccs of normal saline or at capacity. Then 30 minutes will be given to void. The voided volume will be measured using a toilet hat, and the post-void residual will then be measured using a bladder scanner.
Measured: Up to 4 hours postop
Void Test (Fail)
Number of patients that Fail the Void Test. Once the patients are oriented and before leaving PACU, their bladder will be backfilled with 300 ccs of normal saline or at capacity. Then 30 minutes will be given to void. If the patients are unable to void or if the post-void residual is > than 100 ml by bladder scanner, then it will be considered that those patients failed the voiding trial
Measured: Up to 4 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study startAug 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: technical aspects - unable to continue with the study. Investigator left institution. No patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Urinary RetentionStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Duenas Garcia, West Virginia University
- Investigators
- Omar Duenas Garcia, MD, Principal investigator, WVU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664633
- Sponsor's protocol ID
- 2107367192
- Status last verified
- Feb 2025
- First submitted
- 15 Dec 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Determine the Effect of Transient Postoperative Urinary Retention Using Sugammadex (4 Mg X Kg) Versus Glycopyrrolate and Neostigmine (0.01 Mg/kg - 50mg/kg) in Patients Undergoing Vaginal Hysterectomies with and Without Pelvic Organ Prolapse Procedures: a Pilot Study
- ClinicalTrials.gov ID
- NCT05664633
- Acronym / sponsor ID
- 2107367192
- Conditions
- Postoperative Urinary Retention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: technical aspects - unable to continue with the study. Investigator left institution. No patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigator will perform a single-institution randomized double-blinded controlled trial comparing intraoperative Sugammadex vs. standard dose of glycopyrrolate/neostigmine combination for participants undergoing a total vaginal hysterectomy with or without pelvic organ prolapse procedures under general endotracheal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Active comparator | Drug: SugammadexSugammadex dose=4 mg x kg |
| Standard of Care | No intervention | –Standard of care= glycopyrrolate and neostigmine (0.01 mg/kg - 50mg/kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patients undergoing a vaginal hysterectomy with the indications of pelvic organ prolapse or abnormal uterine bleeding
Key exclusion criteria (16 listed)
- Patients who are already known to have voiding dysfunction
- Patients who have a contraindication or intolerance to any of the drugs used in the study
- Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
- Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
- Is dialysis-dependent or has severe renal insufficiency, defined as estimated creatinine clearance of <30 mL/min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexSugammadex or G/N will be given at the end of the procedure once the surgeon communicates with the anesthesiologist. The surgeon will typically do this at the time of putting the closing sutures. | Drug | Sugammadex |
Primary outcome
Void Test (Pass)
Time frame: Up to 4 hours postop
Number of patients that Pass the Void Test. Once the patients are oriented and before leaving PACU, their bladder will be backfilled with 300 ccs of normal saline or at capacity. Then 30 minutes will be given to void. The voided volume will be measured using a toilet hat, and the post-void residual will then be measured using a bladder scanner.
Void Test (Fail)
Time frame: Up to 4 hours post-op
Number of patients that Fail the Void Test. Once the patients are oriented and before leaving PACU, their bladder will be backfilled with 300 ccs of normal saline or at capacity. Then 30 minutes will be given to void. If the patients are unable to void or if the post-void residual is > than 100 ml by bladder scanner, then it will be considered that those patients failed the voiding trial
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Duenas Garcia, MD principal investigator
WVU
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sugammadex in people with Postoperative Urinary Retention, run by West Virginia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Void Test (Pass) (time frame: Up to 4 hours postop). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.