Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Saline
* Drug: Epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine + epinephrine<br> | Drug: Bupivacaine<br>* 10ml 0.5% bupivacaine<br>* Other names: Marcaine;Drug: Epinephrine<br>* 1:200,000 epinephrine<br>|
| Placebo Comparator: Saline + epinephrine<br> | Drug: Saline<br>* 10ml 0.9% sodium chloride<br>* Other names: Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2-3 hours | 
| 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) | 6-7 hours | 
| 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. | At enrollment |