Stress Urinary Incontinence
Conditions
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.
Interventions
DRUGBupivacaine
10ml 0.5% bupivacaine
DRUGSaline
10ml 0.9% sodium chloride
DRUGEpinephrine
1:200,000 epinephrine
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Marcaine + Epinephrine Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine | 41 |
| Saline + Epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine | 39 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | Total | Marcaine + Epinephrine | Saline + Epinephrine |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 11.3 | 46.0 years STANDARD_DEVIATION 11.6 | 50.5 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 80 Participants | 41 Participants | 39 Participants |
| Sex: Female, Male Female | 80 Participants | 41 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Visual Analog Scale for Pain: Preoperative | 0.0 Units on a Scale STANDARD_DEVIATION 1.2 | 0.0 Units on a Scale STANDARD_DEVIATION 1 | 0.0 Units on a Scale STANDARD_DEVIATION 1.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling
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
Population: Passed void trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Marcaine + Epinephrine | Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling | 31 Participants |
| Saline + Epinephrine | Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling | 32 Participants |
Secondary
Post-operative Pain Scale at 6-7 Hours Post op
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Marcaine + Epinephrine | Post-operative Pain Scale at 6-7 Hours Post op | 3.1 units on a scale | Standard Deviation 1.6 |
| Saline + Epinephrine | Post-operative Pain Scale at 6-7 Hours Post op | 4.1 units on a scale | Standard Deviation 1.9 |
Secondary
Post-operative Pain Scores at 2-3 Hours Post op
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Marcaine + Epinephrine | Post-operative Pain Scores at 2-3 Hours Post op | 3 units on a scale | Standard Deviation 2 |
| Saline + Epinephrine | Post-operative Pain Scores at 2-3 Hours Post op | 2.9 units on a scale | Standard Deviation 2.1 |
p-value: 0.837Fisher Exact
Secondary
Visual Analog Scale for Pain: Pre-operative.
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Marcaine + Epinephrine | Visual Analog Scale for Pain: Pre-operative. | 0.0 Reported Pain Level score on VAS | Standard Deviation 1 |
| Saline + Epinephrine | Visual Analog Scale for Pain: Pre-operative. | 0.0 Reported Pain Level score on VAS | Standard Deviation 1.4 |