Trial Outcomes & Findings for Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial (NCT NCT01583166)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

2 weeks

Results posted on

2018-11-28

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Marcaine + Epinephrine Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine	Saline + Epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
Overall Study STARTED	45	45
Overall Study COMPLETED	41	39
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Marcaine + Epinephrine Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine	Saline + Epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
Overall Study Withdrawal by Subject	4	6

Baseline Characteristics

all subjects were included in the baseline assessments the final numbers in the results section differ due to subject withdrawal or drop out

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Marcaine + Epinephrine n=41 Participants Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine	Saline + Epinephrine n=39 Participants Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine	Total n=80 Participants Total of all reporting groups
Age, Continuous	46.0 years STANDARD_DEVIATION 11.6 • n=5 Participants • all subjects were included in the baseline assessments the final numbers in the results section differ due to subject withdrawal or drop out	50.5 years STANDARD_DEVIATION 11.1 • n=7 Participants • all subjects were included in the baseline assessments the final numbers in the results section differ due to subject withdrawal or drop out	48.1 years STANDARD_DEVIATION 11.3 • n=5 Participants • all subjects were included in the baseline assessments the final numbers in the results section differ due to subject withdrawal or drop out
Sex: Female, Male Female	41 Participants n=5 Participants	39 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants • 45 randomized to each, number analyzed differs due to participant withdrawal	39 Participants n=7 Participants • 45 randomized to each, number analyzed differs due to participant withdrawal	80 Participants n=5 Participants • 45 randomized to each, number analyzed differs due to participant withdrawal
Visual Analog Scale for Pain: Preoperative	0.0 Units on a Scale STANDARD_DEVIATION 1 • n=5 Participants	0.0 Units on a Scale STANDARD_DEVIATION 1.4 • n=7 Participants	0.0 Units on a Scale STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Passed void trial

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.

Outcome measures

Outcome measures
Measure	Marcaine + Epinephrine n=41 Participants Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine	Saline + Epinephrine n=39 Participants Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling	31 Participants	32 Participants

SECONDARY outcome

Timeframe: 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

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)

Outcome measures

Outcome measures
Measure	Marcaine + Epinephrine n=41 Participants Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine	Saline + Epinephrine n=39 Participants Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
Post-operative Pain Scores at 2-3 Hours Post op	3 units on a scale Standard Deviation 2	2.9 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Marcaine + Epinephrine n=29 Participants Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine	Saline + Epinephrine n=27 Participants Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
Post-operative Pain Scale at 6-7 Hours Post op	3.1 units on a scale Standard Deviation 1.6	4.1 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Marcaine + Epinephrine n=41 Participants Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine	Saline + Epinephrine n=39 Participants Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
Visual Analog Scale for Pain: Pre-operative.	0.0 Reported Pain Level score on VAS Standard Deviation 1	0.0 Reported Pain Level score on VAS Standard Deviation 1.4

Adverse Events

Marcaine + Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline + Epinephrine

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

Michael Flynn, MD

UMass Worcester

Phone: 508-334-9840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place