Clinical trial NCT05276804
Conditions: Postoperative Urinary Retention
Keywords: Sugammadex
Sponsor: Wake Forest University Health Sciences
Start date: 2022-04-13; Completion date: 2024-09-03
Enrollment: 171 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents

Detailed description:
Postoperative urinary retention following laparoscopic inguinal hernia repair occurs in approximately one out of ten patients. The more rapid reversal of neuromuscular blockade with Sugammadex has empirically been associated with low rates of postoperative urinary retention. In this study, patients will receive Sugammadex following laparoscopic inguinal hernia repair and then be retrospectively matched against a group of patients who did not receive Sugammadex. The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents (e.g. neostigmine which has a retention rate of 5-11%). We will also examine difference in cost and quality of life between the two groups. Our hypothesis is that the use of Sugammadex will decrease rate of postoperative urinary retention, decrease associated cost, such as need for admission, and not negatively impact quality of life.

Arms: arm 1: 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. arm 2: Retrospective cohort of patients who did not receive Sugammadex
Interventions: intervention 1: Sugammadex
Intervention descriptions: intervention 1: 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.

Protocol documents:
Prot_SAP_001.pdf: 
Version Date: 04/20/2022 
IRB Number: 01-22-45E 
The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary Retention 
(POUR) Following Laparoscopic Inguinal Hernia Repair 
Principal Investigator 
B. Todd Heniford, MD 
Division of GI and Minimally Invasive Surgery 
Carolinas Medical Center 
1025 Morehead Medical Drive, Suite 300 
Charlotte NC, 28204 
(704) 355-1813 
Sub-Investigator(s)/Co-Investigator(s) 
Paul Colavita, MD 
Vedra Augenstein, MD 
Michael Katzen, MD 
 
 
 
 
 
 
 
 
 
 
 
 
 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
Funding Source:  
This project has received preliminary approval from the Merck Investigators Studies Program (MISP) 
with a budget of $72,146.78. The budget for the study includes cost of the drug (Sugammadex), pharmacy 
and IRB fees, and payment for the research team. We will provide the budget for the study along with the 
rest of the protocol.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
 
Study Summary: 
 
Postoperative urinary retention following laparoscopic inguinal hernia repair occurs in 
approximately one out of ten patients.1 The more rapid reversal of neuromuscular blockade with 
Sugammadex has empirically been associated with low rates of postoperative urinary retention. In this 
study, patients will receive Sugammadex following laparoscopic inguinal hernia repair and then be 
retrospectively matched against a group of patients who did not receive Sugammadex. The primary aim of 
this study will be to compare the rate of postoperative urinary retention between patients receiving 
Sugammadex and those receiving traditional reversal agents (e.g. neostigmine which has a retention rate 
of 5-11%). We will also examine difference in cost and quality of life between the two groups. Our 
hypothesis is that the use of Sugammadex will decrease rate of postoperative urinary retention, decrease 
associated cost, such as need for admission, and not negatively impact quality of life. 
Background and Rationale: 
Urinary retention is a common complication following laparoscopic inguinal hernia repair, with 
recent studies citing the rate of postoperative urinary retention anywhere from 5-11%.1–4  Age, history of 
benign prostatic hypertrophy, general anesthesia, male gender and postoperative narcotic use have been 
associated with urinary retention following laparoscopic inguinal hernia repair.1,5 The exact effects of 
general anesthesia and a systemic paralytic agent on bladder function and urinary retention are not 
completely clear. However, it is strongly suggested that the lack of complete bladder musculature 
recovery and function in the immediate postoperative period and may lead to urinary retention.6 
Our institutional database contains over 2,500 patients who have undergone either unilateral or 
bilateral laparoscopic inguinal hernia repair. Currently our overall rate of urinary retention in all patients 
in our database is 7.3%, or 185 of the 2,551 patients. In the 90 patients who were both over the age of 60 
and had benign prostatic hypertrophy symptoms, the rate was 15.6%. Postoperative urinary retention 
potentially requires prolonged post-anesthesia care unit (PACU) stay, overnight hospital admission, return 
to the emergency department, need for an indwelling catheter and further physician assessment, 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
prolonged micturition difficulties, and urinary tract infection and other catheter-related complications.7 
Urinary retention can be detrimental to the overall health of our surgical patients.  
Sugammadex has been anecdotally reported to decrease rates of postoperative urinary retention 
following laparoscopic inguinal hernia repair. The more rapid reversal of neuromuscular blockade helps 
to explain this claim. In other areas of surgery, such as orthopedics, Sugammadex has already been 
associated with reduced anticholinergic usage and decreased rates of postoperative urinary retention.8 The 
cost efficacy of Sugammadex has yet to be determined as it is more expensive than traditional reversal 
counterparts; however, if it significantly decreases rates of postoperative urinary retention it could reduce 
healthcare costs that are downstream.9 Given that the reported incidence of postoperative urinary retention 
is high after laparoscopic inguinal hernia repair, and given this is one of the most common general 
surgery operations performed, the results of this study will certainly be widely applicable.10   
Study Objectives 
Objectives –  
1. The primary objective of this study will be to compare urinary retention rates when using 
Sugammadex for neuromuscular reversal compared to neostigmine. The patients receiving 
Sugammadex will be enrolled prospectively and those who received neostigmine will be 
identified retrospectively on chart review.  
2. We will secondarily evaluate length of stay (in postoperative recovery or in the hospital), charges 
accrued by patients, and quality of life compared to patients who received neostigmine. 
Hypotheses –  
1. We hypothesize that the use of Sugammadex as a neuromuscular reversal agent will decrease 
postoperative urinary retention after laparoscopic inguinal hernia repair compared to patients who 
received neostigmine. 
2. We also hypothesize that there will be decreased postoperative length of stay, total hospital 
charges accrued by patients, and no negative impact on quality of life compared to patients who 
received neostigmine. 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
Study Design/Methods: 
In this study, a prospective cohort of patients undergoing laparoscopic inguinal hernia repair will 
receive Sugammadex and then retrospectively be matched against a cohort of patients who did not receive 
Sugammadex. The patients will be matched based on age, gender, history of BPH, bilateral vs. unilateral 
hernia, opioid usage with morphine milliequivalents, and operative time. The patients will be consented 
when they present to clinic for the evaluation of their inguinal hernia as the primary means of consent or 
in the preoperative area as a secondary means of consent. The operating surgeon will notify the research 
team, consisting of a resident physician and two full time research analysts, when the patient is in clinic 
and expresses interest in the study. One of the members of the research team will see the patient and 
consent them for the study as the primary consent process. Patients will be identified prior to the day of 
surgery and, if not previously contacted in clinic, will be contacted via telephone about participating in 
the study. If the patient agrees to participate prior to the day of surgery, a member of the aforementioned 
research team will consent the patient on the day of surgery prior to the procedure as the secondary 
consent process. Inclusion and exclusion criteria are defined below. Neither the patient nor the surgeon 
will be blinded in this study, but we do not anticipate that this will in any way change management.  
Inclusion Criteria: 
• 
Over the age of 18  
• 
Undergoing laparoscopic inguinal hernia repair at Carolinas Medical Center by attending 
surgeons within the Division of Gastrointestinal and Minimally Invasive Surgery 
• 
Unilateral or bilateral inguinal hernia repair; may have concurrent umbilical hernia repair 
performed 
• 
Agreeable to participation in the study 
Exclusion Criteria:  
• 
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) 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
• 
End-stage renal disease (Creatinine clearance less than 30) 
• 
Neuromuscular disease 
• 
Prior adverse reactions to Sugammadex  
• 
Patients who do not provide consent for the study  
On the day of surgery, the research team will be present in the preoperative area and 
communicate directly with the anesthesia team that this is a patient who will be receiving Sugammadex; 
this communication is important because Sugammadex can only reverse vecuronium or rocuronium.11 
The Investigational Drug Service Department at Atrium Health will be notified the day before that there 
will be a patient included in the study the day prior to the operation. Their pharmacists will have the drug 
present for the anesthesiology team. This will not be a blinded study, so the anesthesia team and even the 
surgeon can know that the patient is receiving Sugammadex. In this study, patients will receive 
Sugammadex, in accordance with FDA approved labeling, following laparoscopic inguinal hernia repair 
and then be retrospectively matched against a group of patients who did not receive Sugammadex. 
The definition that we will be using for urinary retention is the inability to void at six hours 
postoperatively which will be recorded in the postoperative recovery area and the same definition for 
urinary retention will be applied to the comparative retrospective cohort. Patients will be required to void 
prior to their discharge from the hospital. The requirement for urinary catheterization will be secondarily 
recorded. The details of the patient’s operation, postoperative recovery, and potential admission encounter 
will be obtained and enter into the electronic health record into our pre-existing hernia database. Details 
about the cost to the patient will be obtained from a monthly billing statement that is generated for our 
department in EpicTM Systems. Patients will be seen in clinic postoperatively, typically within one to two 
weeks, and a quality of life questionnaire will be administered. This questionnaire is the same form that is 
typically used in our surgical clinics and will provide a means for retrospective comparison. 
The data entry will be performed by two data analysts that are employed by our division. Once 
this data has been entered for all patients, our statistician will perform an analysis using Statistical 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
Analysis Software, version 9.4 (SAS Institute, Inc., Cary, NC) and send this data to the investigators for 
review. The principal investigator (PI) and co-investigators will be responsible for composing the 
abstracts and manuscript for this project.  
Study Flow Chart (Overview): 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruit Patients in Surgery Clinic @ 
CMC or via telephone & Consent 
Sugammadex Cohort to Undergo 
Laparoscopic Inguinal Hernia Repair, 
Assess Post-Op Quality of Life  
Data Entry by Research Analysts into 
Institutional Database 
Propensity Match Sugammadex Cohort 
w/ Non-Sugammadex Cohort (Pre-
existing). Run Stats in SAS. 
Interpretation of Data, Drafting of 
Abstracts and Manuscripts 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
 
 
Specific Drug Supply Requirements:  
 
For the treatment group, 140 patients will require Sugammadex 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. 
Study Duration:  
Conservatively, the Division of Gastrointestinal and Minimally Invasive Surgery group performs 
five laparoscopic inguinal hernia repairs per week. A total of 140 patients will receive Sugammadex in 
the study. If all patients undergoing laparoscopic inguinal hernia repair agreed to participate in the study, 
then it would require 28 weeks for all patients to have surgery. Given that not all patients will not be 
agreeable to participation, and to allow time for statistical analysis, we estimate that 40 weeks will be 
required to complete the study. 
Statistical Analysis and Sample Size Justification:  
Variables/Time Points of Interest – Basic demographic information for each patient will be obtained from 
the medical record, such as age, gender, ASA class, and prior medical histories/surgeries. This 
information will aid in propensity matching for the study. The propensity match will be 1:1 with an equal 
number of patients in each group. The match will ensure that there is no statistical difference in data 
points between the groups and it will be performed by our statistician using SAS. The primary outcome 
variable, postoperative urinary retention, is a categorical variable (yes/no) that will be documented in 
postoperative recovery after the patient’s operation. Length of stay and hospital cost, continuous 
variables, will be recorded at the completion of the patient’s hospital stay. Information about quality of 
life will be obtained postoperatively in clinic. The demographic information, primary and secondary 
outcomes will be entered into our institutional database along with the other information that is typically 
recorded, such as operative characteristics and patient follow up. 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
Statistical Methods - Data will be analyzed using Statistical Analysis Software, version 9.4 (SAS 
Institute, Inc., Cary, NC); this task will be performed by the statistician employed by our division. 
Descriptive statistics will be reported as means with corresponding standard deviations for continuous 
variables and percentages for categorical variables. Continuous and ordinal variables will be evaluated 
with the Wilcoxon-Mann Whitney and the Kruskal-Wallis tests. The Wilcoxon-Mann Whitney test will 
be used when normality exists and there are two variables for comparison, otherwise, the Kruskal-Wallis 
test will be used. For categorical variables, a Pearson chi-square will be used, and a Fisher exact test will 
be utilized with a small sample size (i.e. less than five). A two-sided p-value of <0.05 will be used for all 
significance determinations. 
Power/Sample Size – Using SAS, the power for our study was calculated using the postoperative urinary 
retention rate at our institution, 7%, compared to a current 0.5% postoperative urinary retention rate using 
Sugammadex. With 80% power, we would need to enroll 140 patients per group. The data for this project 
will be interpreted by the PI for the project as well as the co-investigators. 
Risks and Benefits 
 
The risk to the patient is minimal. Common side effects of Sugammadex are dizziness, tremor, 
lightheadedness, hypotension and tachycardia, but they are rare.12 Patients will be excluded with renal 
disease or neuromuscular disease, which could be exacerbated by the use of Sugammadex. Women of 
childbearing age will be encouraged to use a second form of barrier contraceptive to prevent pregnancy. 
Adverse Experience Reporting will proceed in accordance with the policies and standards of Atrium 
Health. Patients in the study will be informed to report any adverse experiences related to this study 
directly to the research staff for the division. Reporting of such events can also be made directly to North 
Carolina Department of Health and Human Services. 
 
Based on the limited amount of patients who have received Sugammadex to this point at CMC, 
we anticipate decreased rates of postoperative urinary retention. A decrease in urinary retention would be 
the main benefit for patients. 
 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
Confidentiality and Data Storage 
 
Data will be collected electronically for this project and be stored on a secure server that is 
accessible only by password to the research team. Information for the study will be de-identified and 
names and medical record numbers will not be used in presentation or publication of the data. The data 
itself will be kept for a period of 5 years after study closure and destroyed by overwriting and deleting the 
file 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of study 
participants.  The principal investigator will be assisted by other members of the study staff. Dr. Ronald 
Sing ((704) 355-3776) will serve as the DSMP for this study. 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes will 
be promptly reported by the principal investigator or designated member of the research team to the IRB 
and sponsor or appropriate government agency if appropriate. 
References: 
 1.  
Patel JA, Kaufman AS, Howard RS, Rodriguez CJ, Jessie EM. Risk factors for urinary retention 
after laparoscopic inguinal hernia repairs. Surg Endosc. 2015;29(11):3140-3145. 
doi:10.1007/s00464-014-4039-z 
2.  
Huerta S, Timmerman C, Argo M, et al. Open, Laparoscopic, and Robotic Inguinal Hernia Repair: 
Outcomes and Predictors of Complications. J Surg Res. 2019;241:119-127. 
doi:10.1016/j.jss.2019.03.046 
3.  
Roadman D, Helm M, Goldblatt MI, et al. Postoperative urinary retention after laparoscopic total 
extraperitoneal inguinal hernia repair. J Surg Res. 2018;231:309-315. 
doi:10.1016/j.jss.2018.05.052 


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
4.  
Arnold MR, Coakley KM, Fromke EJ, et al. Long-term assessment of surgical and quality-of-life 
outcomes between lightweight and standard (heavyweight) three-dimensional contoured mesh in 
laparoscopic inguinal hernia repair. Surg (United States). 2019;165(4):820-824. 
doi:10.1016/j.surg.2018.10.016 
5.  
Scott AJ, Mason SE, Langdon AJ, et al. Prospective Risk Factor Analysis for the Development of 
Post-operative Urinary Retention Following Ambulatory General Surgery. World J Surg. 
2018;42(12):3874-3879. doi:10.1007/s00268-018-4697-4 
6.  
Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: Anesthetic and 
perioperative considerations. Anesthesiology. 2009;110(5):1139-1157. 
doi:10.1097/ALN.0b013e31819f7aea 
7.  
Blair AB, Dwarakanath · A, Mehta · A, et al. Postoperative urinary retention after inguinal hernia 
repair: a single institution experience. Hernia. 2017;21:895-900. doi:10.1007/s10029-017-1661-4 
8.  
Cha J-E, Park SW, Choi YI, et al. Sugammadex use can decrease the incidence of post-operative 
urinary retention by avoiding anticholinergics: a retrospective study. Anesth Pain Med. 
2018;13(1):40-46. doi:10.17085/apm.2018.13.1.40 
9.  
Cammu G. Sugammadex: Appropriate Use in the Context of Budgetary Constraints. Curr 
Anesthesiol Rep. 2018;8(2):178-185. doi:10.1007/s40140-018-0265-6 
10.  
Decker MR, Dodgion CM, Kwok AC, et al. Specialization and the current practices of general 
surgeons. J Am Coll Surg. 2014;218(1):8-15. doi:10.1016/j.jamcollsurg.2013.08.016 
11.  
Herring WJ, Woo T, Assaid CA, et al. Sugammadex efficacy for reversal of rocuronium- and 
vecuronium-induced neuromuscular blockade: A pooled analysis of 26 studies. J Clin Anesth. 
2017;41:84-91. doi:10.1016/j.jclinane.2017.06.006 
12.  
Kim YH. Sugammadex: Watch out for new side effects. Korean J Anesthesiol. 2016;69(5):427-


Version Date: 04/20/2022 
IRB Number: 01-22-45E 
428. doi:10.4097/kjae.2016.69.5.427 
 
 
 

ICF_002.pdf: 
NCT05276804
The POUR Study: Effects of Neuromuscular Reversal 
Agents on Postoperative Urinary Retention (POUR) 
Following Laparoscopic Inguinal Hernia Repair 
IRB Approved Date:  11.20.2023


The POUR Study
Date Written: 12/22/2022
Page 1 of 7
ATRIUM HEALTH
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
AND AUTHORIZATION TO DISCLOSE HEALTH INFORMATION
Sponsor / 
Study Title:
Merck Investigator Studies Program (MISP) / The POUR Study: 
Effects of Neuromuscular Reversal Agents on Postoperative Urinary 
Retention (POUR) Following Laparoscopic Inguinal Hernia Repair
Principal 
Investigator:
(Study Doctor)
B. Todd Heniford, MD
Telephone:
Address:
INTRODUCTION
Dr. Todd Heniford is asking you to participate in this study that aims to improve rate of urinary 
retention following laparoscopic inguinal hernia repair. You are being asked to take part because 
you have been diagnosed with an inguinal hernia and are undergoing surgical repair. The 
purpose of this study is to assess the effect of the Sugammadex, on postoperative urinary 
retention. During surgery, a medicine is given to paralyze muscles. As surgery is ending, 
Sugammadex can be given to reverse muscle paralysis. Relaxed muscles, if not reversed, may 
contribute to urinary retention. The rate of urinary retention is normally 7-8% following inguinal 
hernia repair. Thus far, Sugammadex has been found to reduce the rate of postoperative urinary 
retention. Patients enrolled in this study will be compared to previous patients who underwent 
reversal with the reversal agent neostigmine. 
Please read this form carefully. Take time to ask the study doctor or study staff as many 
questions about the study as you would like. The study doctor or study staff can explain words or 
information that you do not understand. Reading this form and talking to the study doctor or 
study staff may help you decide whether to take part or not. If you decide to take part in this 
study, you must sign and date your name at the end of this form. You cannot take part in this 
research study until you sign and date this form.
HOW THE STUDY WORKS
If you agree to be in the study, you will undergo laparoscopic inguinal hernia repair with one of 
the surgeons in the Division of Gastrointestinal & Minimally Invasive Surgery. The operation 
will be performed in standard fashion. Following surgery, you may or may not receive 
Sugammadex to reverse the paralytic received prior to surgery. This is dependent upon eligibility 
criteria and/or any issues during surgery that may exclude you from participation. Sugammadex 
is FDA approved as a reversal agent and is considered standard of care following laparoscopic 
inguinal hernia repair, however, is not used as standard of care at this facility. You will be 
monitored in the postoperative recovery room. Postoperative urinary retention will be defined as 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083113
Meeting Date Approved 11/20/2023          
Version Valid Until: 11/19/2024


The POUR Study
Date Written: 12/22/2022
Page 2 of 7
the need for catheterization due to lack of urination within six hours after surgery. Other 
operative details (i.e. age, gender, ASA class, length of stay, prior surgeries, etc.) will be 
recorded as well as the cost of the operation and any need for subsequent hospitalization. 
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
One-hundred and forty (140) participants will be enrolled into the prospective group of this 
study. These 140 participants will receive Sugammadex as part of this study. One-hundred and 
forty (140) participants will be included in the retrospective group of this study as a comparison 
group. These 140 participants have had a previous inguinal hernia repair at our institution but did 
not receive Sugammadex. The total number of patients in this study will be 280. 
WHAT IS INVOLVED IN THE STUDY?
This study will consist of the following steps:
Step 1: You will be seen in clinic for a consultation visit
Step 2: The attending surgeon will introduce the study to you
Step 3: A member of the research team (attending surgeon, fellow, resident, research manager or 
research associate) will explain the study to you and, if interested, will consent you to participate 
in the study
Step 4: The attending surgeon will perform your procedure using Sugammadex
Step 5: Post operative urinary retention will be assessed at 6-hours after surgery. This will be 
assessed by the ability to void the bladder (urinate)
Step 5: You will be seen back in clinic 1-2 weeks post-surgery for a standard of care follow up 
visit. At this visit you will be asked to complete a quality of life questionnaire (Carolinas 
Comfort Scale). This questionnaire will allow the research team to compare your quality of life 
after receiving Sugammadex to the quality of life of the patients in the retrospective group who 
did not receive Sugammadex
INCLUSION/EXCLUSION CRITERIA:
Inclusion Criteria:

18 years of age and older

Undergoing laparoscopic inguinal hernia repair at Carolinas Medical Center by attending 
surgeons within the Division of Gastrointestinal and Minimally Invasive Surgery

Unilateral or bilateral inguinal hernia repair; may have concurrent umbilical hernia repair 
performed

Agreeable to participation in the study
Exclusion Criteria: 

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)

End-stage renal disease (Creatinine clearance less than 30)

Neuromuscular disease

Prior adverse reactions to Sugammadex 

Patients who do not provide consent for the study 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083113
Meeting Date Approved 11/20/2023          
Version Valid Until: 11/19/2024


The POUR Study
Date Written: 12/22/2022
Page 3 of 7
RISKS
We overall anticipate minimal risks in participation of this study. Common side effects of 
Sugammadex are dizziness, tremor, lightheadedness, hypotension and tachycardia, but they are 
rare. Patients with kidney disease and neuromuscular disease are not allowed to participate due 
to potentially worsening of those pre-existing conditions. Other risks include loss of 
confidentiality, which will be low as patient information is de-identified and the data is password 
protected.
Reproductive Risks and other Issues to Participating in Research
Due to unknown risks and potential harm to the unborn fetus, sexually active women of 
childbearing potential must use a reliable method of birth control while participating in this 
study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, 
OrthoEvra patch, NuvaRing, intrauterine devices (IUD), Nexplanon implant, DepoProvera, tubal 
ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous 
relationship (same partner). An acceptable, although less reliable, method involves the careful 
use of condoms and spermicidal foam or gel and/or a diaphragm with spermicide with Plan B 
used for any noticed condom or diaphragm failures. We encourage you to discuss this issue 
further with your physicians if you have any questions.
BENEFITS
The possible benefit is that you will not have postoperative urinary retention following 
laparoscopic inguinal hernia repair. This will avoid need for catheterization and potentially 
hospitalization. 
ALTERNATIVE PROCEDURE/TREATMENT
If you choose not to participate in this study, your hernia will continued to be treated with 
standard of care procedures. Throughout the study, your participation will be completely 
voluntary. 
ADDITIONAL COST
You will not have any additional costs as a result of participation in this program. Merck will 
cover the cost of the Sugammadex.
COMPENSATION
There will be no monetary compensation for participating in this study.
COMPENSATION FOR INJURY
In the event that you are harmed as a result of your participation in this study, we will provide or 
arrange for treatment as necessary. This treatment, as well as other medical expenses, will be 
billed to you or your insurance company in the usual manner. You do not waive any legal rights 
by signing this consent form.
WITHDRAWAL
Your participation in this study is completely voluntary. You should feel under no pressure to be 
in the study. If you decide not to be in the study, which will not in any way harm your relations 
with your doctors or with Atrium Health. You are free to stop being in the study if you change 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083113
Meeting Date Approved 11/20/2023          
Version Valid Until: 11/19/2024


The POUR Study
Date Written: 12/22/2022
Page 4 of 7
your mind after entering it. This would not harm your relations with your doctors or Atrium 
Health.

You may always say no. You do not have to take part in the study.

If you start a study, you may stop at any time. You do not need to give a reason.

If you do not want to be in a study or you stop the study at a later time, you will not be 
penalized or lose any benefits.

If you stop, you should tell the study staff and follow the instructions they may give you.
Your part in the research may stop at any time for any reason, such as:

The sponsor or the study doctor decides to stop the study.

The sponsor or the study doctor decides to stop your part in the study for your safety.

You need additional medicine.

You do not follow the study rules.

You have a new injury or illness.

You decide to stop.
You may be asked to stop the study even if you do not want to stop.
NEW INFORMATION ABOUT THE STUDY
You will be told about any new information found during the study that may affect whether you 
want to continue to take part.
CONFIDENTIALITY
The records of this study will be kept private. If any report about this research is published, we 
will not include any information that will make it possible to identify you. However, there is 
some risk that de-identified data might be re-identified. Also, your record for this study may be 
reviewed and/or photocopied by Atrium Health, or by representatives of the Food and Drug 
Administration or other government agencies.
AUTHORIZATION TO USE AND DISCLOSE YOUR PROTECTED HEALTH 
INFORMATION 
If you wish to participate in this research study, you 
___________________________________________________________
Printed Name of Research Subject
must sign this Authorization. By signing this Authorization, you give all healthcare 
providers, including Atrium Health, permission to use or disclose (release) your protected 
health information, both past and present, for the research study described here:
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083113
Meeting Date Approved 11/20/2023          
Version Valid Until: 11/19/2024


The POUR Study
Date Written: 12/22/2022
Page 5 of 7
If you wish to participate in this research study, you must sign this Authorization. By signing this 
Authorization, you give all healthcare providers, including Atrium Health, permission to use or 
disclose (release) your protected health information, both past and present, for the research study 
described here:
The POUR Study: Effects of Neuromuscular Reversal Agents on Postoperative Urinary 
Retention (POUR) Following Laparoscopic Inguinal Hernia Repair
The protected health information that we may use or disclose (release) for this research may 
include all information in your medical record, such as results of physical examinations, medical 
history, lab tests, or certain health information indicating or relating to a particular condition.
The health information listed above may be used by and/or disclosed (released) to:

Study investigator and research staff

Regulatory or other governmental authorities of the United States or other countries 
based on this study

Atrium Health Employees

Atrium Health Institutional Review Board
Atrium Health is required by law to protect your protected health information. By signing this 
Authorization, you authorize Atrium Health to use and/or disclose (release) your protected health 
information for this research study. Those persons who receive your protected health information 
may not be required by Federal privacy laws (such as the Privacy Rule) to protect it and may 
share your protected health information with others without your permission, if permitted by 
laws governing them. Your protected health information may then no longer be protected by the 
Privacy Rule. 
Please note that you do not have to sign this Authorization, but if you do not, you may not 
receive research-related treatment through this study. However, Atrium Health may not 
condition (withhold or refuse) your other Atrium Health providers treating you on whether you 
sign this Authorization. You may change your mind and withdraw (take back) this Authorization 
at any time, except to the extent that Atrium Health or the Sponsor has already used or disclosed 
your protected health information based on this Authorization. To withdraw this Authorization, 
you must write to the Study Doctor at the address listed on the first page of this form.
No publication or public presentation about the research described above will reveal your 
identity without another Authorization from you. If all protected health information that does or 
can identify you is removed, the remaining information will no longer be subject to this 
Authorization or federal rules (such as the Privacy Rule) and may be used or disclosed for other 
purposes.
When the research for which the use or disclosure is made involves treatment and is conducted 
by Atrium Health: To maintain the integrity of this research study, you generally will not have 
access to your personal health information related to this research until the study is complete. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083113
Meeting Date Approved 11/20/2023          
Version Valid Until: 11/19/2024


The POUR Study
Date Written: 12/22/2022
Page 6 of 7
At the conclusion of the research study and at your request, you generally will have access to 
your protected health information. Access to your protected health information in a medical 
record is described in the Notice of Privacy Practices provided to you by Atrium Health. 
When conducting research, the data and results may be used or disclosed for further treatment 
outcomes research or to research a secondary result. This Authorization will remain in effect 
after the end of the current study, and any future related secondary study unless it is revoked by 
the you in writing as described above.
___________________________________________________________
Signature of participant or participant’s Legally Authorized Representative
____________________________________________________________
Printed name of participant or participant’s Legally Authorized Representative
_________________
Date
FINANCIAL INTEREST OF INVESTIGATOR
The doctors will receive no financial benefit in any form by asking you to participate in this 
study.
QUESTIONS
During the study, if you experience any medical problems, suffer a research-related injury, or 
have questions, concerns or complaints about the study, please contact the Investigator at the 
telephone number listed on the first page of this consent document. If you seek emergency care, 
or hospitalization is required, alert the treating physician that you are participating in this 
research study. 
An institutional review board (IRB) is an independent committee established to help protect the 
rights of research subjects. If you have any questions about your rights as a research subject, 
and/or concerns or complaints regarding this research study, please contact the study doctor 
listed on page one of this form. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083113
Meeting Date Approved 11/20/2023          
Version Valid Until: 11/19/2024


The POUR Study
Date Written: 12/22/2022
Page 7 of 7
STATEMENT OF CONSENT 
I have read this form and its contents were explained to me. I agree to be in this research study 
for the purposes listed above. All my questions were answered to my satisfaction. I will receive a 
signed and dated copy of this form for my records. I am not giving up any of my legal rights by 
signing this form. 
_______________________________/____/____ _________
Signature of Research SubjectDate/Time
___________________________________
Printed Name of Research Subject
STATEMENT OF PERSON EXPLAINING CONSENT 
I have carefully explained to the subject the nature and purpose of the above study. There has 
been an opportunity for the subject to ask questions about this research study. I have been 
available to answer any questions that the subject has about this study.
_______________________________/____/____ _________
Signature of Person Explaining ConsentDate/Time
___________________________________
Printed Name of Person Explaining Consent
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00083113
Meeting Date Approved 11/20/2023          
Version Valid Until: 11/19/2024