Trial Outcomes & Findings for The POUR (Postoperative Urinary Retention) Study (NCT NCT05276804)
NCT ID: NCT05276804
Last Updated: 2025-07-09
Results Overview
Urinary retention is defined as 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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
171 participants
Primary outcome timeframe
6 hours postop
Results posted on
2025-07-09
Participant Flow
74 prospectively enrolled into Sugammadex group 74 retrospectively matched from baseline (non-Sugammadex) group
Participant milestones
| Measure |
Sugammadex
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.
|
Retrospective Cohort
Retrospective cohort of patients who did not receive Sugammadex
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
74
|
|
Overall Study
COMPLETED
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
23
|
0
|
Reasons for withdrawal
| Measure |
Sugammadex
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.
|
Retrospective Cohort
Retrospective cohort of patients who did not receive Sugammadex
|
|---|---|---|
|
Overall Study
screen failure
|
23
|
0
|
Baseline Characteristics
The POUR (Postoperative Urinary Retention) Study
Baseline characteristics by cohort
| Measure |
Sugammadex
n=74 Participants
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.
|
Retrospective Cohort
n=74 Participants
Retrospective cohort of patients who did not receive Sugammadex
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 Years
STANDARD_DEVIATION 15.5 • n=99 Participants
|
59.2 Years
STANDARD_DEVIATION 14.6 • n=107 Participants
|
59.3 Years
STANDARD_DEVIATION 15.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
History of BPH (Benign prostatic hyperplasia)
Yes
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
History of BPH (Benign prostatic hyperplasia)
No
|
64 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Side of Inguinal Repair
Unilateral
|
44 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Side of Inguinal Repair
Bilateral
|
30 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Surgical Repair Technique
Laparoscopic
|
35 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Surgical Repair Technique
Robotic
|
39 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Tobacco Status
Never
|
39 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Tobacco Status
Former
|
30 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Tobacco Status
Current
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Primary vs Recurrent Repair
Primary
|
63 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Primary vs Recurrent Repair
Recurrent
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Diabetes Status
Yes
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Diabetes Status
No
|
68 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Steroids Use
Yes
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Steroids Use
No
|
69 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 hours postopUrinary retention is defined as 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
Outcome measures
| Measure |
Sugammadex
n=74 Participants
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.
|
Retrospective Cohort
n=74 Participants
Retrospective cohort of patients who did not receive Sugammadex
|
|---|---|---|
|
Number of Participants With Urinary Retention
Yes
|
0 Participants
|
11 Participants
|
|
Number of Participants With Urinary Retention
No
|
74 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: From post op to discharge (up to 365 days)Patients will be followed from post surgery until discharge to determine the interim time
Outcome measures
| Measure |
Sugammadex
n=74 Participants
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.
|
Retrospective Cohort
n=74 Participants
Retrospective cohort of patients who did not receive Sugammadex
|
|---|---|---|
|
Length of Stay (Days)
|
0.0 Days
Standard Deviation 0.1
|
0.3 Days
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: At discharge (up to 365 days)Patient costs associated with procedure and hospital stay
Outcome measures
| Measure |
Sugammadex
n=74 Participants
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.
|
Retrospective Cohort
n=74 Participants
Retrospective cohort of patients who did not receive Sugammadex
|
|---|---|---|
|
Hospital Cost
|
57954 USD
Standard Deviation 13448
|
54970 USD
Standard Deviation 19324
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2Population: This outcome measure type was entered incorrectly when the study was initially registered. The QOL survey should have been designated as "other."
Quality of life survey given post hernia repair to evaluate mesh sensation, pain and movement limitations. 23 total items. Each item is scored 0 (no symptoms) to 5 (disabling symptoms). Total score range is 0-115 with a low score indicating surgery had no negative impact on quality of life.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Number of minutes the operation lasted
Outcome measures
| Measure |
Sugammadex
n=74 Participants
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.
|
Retrospective Cohort
n=74 Participants
Retrospective cohort of patients who did not receive Sugammadex
|
|---|---|---|
|
Operation Time
|
105.9 minutes
Standard Deviation 26.8
|
102.1 minutes
Standard Deviation 51.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Morphine milligram equivalents (MME) represents the potency of an opioid dose relative to morphine. MME is intended to help clinicians make safe, appropriate decisions concerning changes to opioid regimens.
Outcome measures
| Measure |
Sugammadex
n=74 Participants
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.
|
Retrospective Cohort
n=74 Participants
Retrospective cohort of patients who did not receive Sugammadex
|
|---|---|---|
|
Morphine Milligram Equivalents
|
38.3 milligrams
Standard Deviation 11.9
|
38.0 milligrams
Standard Deviation 17.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 2Number of participants with clean wounds based on the Center for Disease Control and Prevention (CDC) Wound guidelines. CDC wound classification options are Clean, Clean-Contaminated, Contaminated, and Dirty/Infected.
Outcome measures
| Measure |
Sugammadex
n=74 Participants
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.
|
Retrospective Cohort
n=74 Participants
Retrospective cohort of patients who did not receive Sugammadex
|
|---|---|---|
|
Number of Participants With Clean Wounds at Follow Up
|
74 participants
|
74 participants
|
Adverse Events
Sugammadex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Retrospective Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place