URINE&ME: Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Bupivacaine + epinephrine
|
Drug: Bupivacaine
10ml 0.5% bupivacaine
Other Names:
Drug: Epinephrine
1:200,000 epinephrine
|
Placebo Comparator: Saline + epinephrine
|
Drug: Saline
10ml 0.9% sodium chloride
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling [2 weeks]
Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual.
Secondary Outcome Measures
- Post-operative Pain Scores at 2-3 Hours Post op [2-3 hours]
Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)
- Post-operative Pain Scale at 6-7 Hours Post op [6-7 hours]
Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)
- Visual Analog Scale for Pain: Pre-operative. [At enrollment]
Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures
Exclusion Criteria:
-
Undergoing procedure in addition to the sling
-
Not competent to give consent
-
Using intermittent self catheterization pre-operatively
-
Known allergy to local anesthetic
-
Undergoing spinal anesthesia for the procedure
-
Prisoners
-
Non-English speaker
-
Under 18 years of age
-
Has a condition that would contra-indicate the use of local anesthetic or epinephrine
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Massachusetts | Worcester | Massachusetts | United States | 01655 |
Sponsors and Collaborators
- University of Massachusetts, Worcester
Investigators
- Principal Investigator: Michael Flynn, MD, University of Massachusetts, Worcester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14197
Study Results
Participant Flow
Recruitment Details | Subjects with stress incontinence or stress-predominant mixed urinary incontinence who were scheduled to undergo a retropubic midurethral sling with no concomitant procedures at UMass Memorial Healthcare, Inc. Enrollment occurred from March 2012 to June 2015 with study presented and consent sought at time of preoperative appointment. |
---|---|
Pre-assignment Detail | 10 participants did not receive allocated intervention--patient-initiated cancellation of surgery. (Saline + Epinephrine n=6, Bupivavane + Epinephrine n=4). Midway through study, indigo carmine became unavailable and surgical team opted for phenazopyridine. Failed to obtain 6-7 hour pain score in 24 out of 80 subjects. |
Arm/Group Title | Marcaine + Epinephrine | Saline + Epinephrine |
---|---|---|
Arm/Group Description | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine |
Period Title: Overall Study | ||
STARTED | 45 | 45 |
COMPLETED | 41 | 39 |
NOT COMPLETED | 4 | 6 |
Baseline Characteristics
Arm/Group Title | Marcaine + Epinephrine | Saline + Epinephrine | Total |
---|---|---|---|
Arm/Group Description | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine | Total of all reporting groups |
Overall Participants | 41 | 39 | 80 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
46.0
(11.6)
|
50.5
(11.1)
|
48.1
(11.3)
|
Sex: Female, Male (Count of Participants) | |||
Female |
41
100%
|
39
100%
|
80
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||
United States |
41
100%
|
39
100%
|
80
100%
|
Visual Analog Scale for Pain: Preoperative (Units on a Scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Units on a Scale] |
0.0
(1)
|
0.0
(1.4)
|
0.0
(1.2)
|
Outcome Measures
Title | Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling |
---|---|
Description | Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual. |
Time Frame | 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Passed void trial |
Arm/Group Title | Marcaine + Epinephrine | Saline + Epinephrine |
---|---|---|
Arm/Group Description | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine |
Measure Participants | 41 | 39 |
Count of Participants [Participants] |
31
75.6%
|
32
82.1%
|
Title | Post-operative Pain Scores at 2-3 Hours Post op |
---|---|
Description | Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain) |
Time Frame | 2-3 hours |
Outcome Measure Data
Analysis Population Description |
---|
Please notice that the number of subjects is different because we only analyzed the pain scores from the subjects who were randomized and had the surgery. We also had some missing pain scores |
Arm/Group Title | Marcaine + Epinephrine | Saline + Epinephrine |
---|---|---|
Arm/Group Description | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine |
Measure Participants | 41 | 39 |
Mean (Standard Deviation) [units on a scale] |
3
(2)
|
2.9
(2.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Marcaine + Epinephrine, Saline + Epinephrine |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.837 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Post-operative Pain Scale at 6-7 Hours Post op |
---|---|
Description | Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain) |
Time Frame | 6-7 hours |
Outcome Measure Data
Analysis Population Description |
---|
Study team failed to obtain 6-7 hour pain score for 24 out of the 80 participants. The overall number of participants analyzed reflects this occurence. |
Arm/Group Title | Marcaine + Epinephrine | Saline + Epinephrine |
---|---|---|
Arm/Group Description | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine |
Measure Participants | 29 | 27 |
Mean (Standard Deviation) [units on a scale] |
3.1
(1.6)
|
4.1
(1.9)
|
Title | Visual Analog Scale for Pain: Pre-operative. |
---|---|
Description | Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain. |
Time Frame | At enrollment |
Outcome Measure Data
Analysis Population Description |
---|
Please noticed that there is a discrepancy with the number of subjects. We include the data from all subjects who were randomized and had the intervention. |
Arm/Group Title | Marcaine + Epinephrine | Saline + Epinephrine |
---|---|---|
Arm/Group Description | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine |
Measure Participants | 41 | 39 |
Mean (Standard Deviation) [Reported Pain Level score on VAS] |
0.0
(1)
|
0.0
(1.4)
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Marcaine + Epinephrine | Saline + Epinephrine | ||
Arm/Group Description | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine | ||
All Cause Mortality |
||||
Marcaine + Epinephrine | Saline + Epinephrine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/45 (0%) | 0/45 (0%) | ||
Serious Adverse Events |
||||
Marcaine + Epinephrine | Saline + Epinephrine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/45 (0%) | 0/45 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Marcaine + Epinephrine | Saline + Epinephrine | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/45 (0%) | 0/45 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Michael Flynn, MD |
---|---|
Organization | UMass Worcester |
Phone | 508-334-9840 |
michael.flynn@umassmemorial.org |
- 14197