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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: Bupivacaine; Drug: Saline; Drug: Epinephrine

• Registration Number: NCT01583166
• Lead Sponsor: University of Massachusetts, Worcester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-23
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2018-05-02
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-29
• Last Update Submitted: 2018-10-29
• Results First Posted: 2018-11-28
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bupivacaine + epinephrine	Bupivacaine	-
Bupivacaine + epinephrine	Epinephrine	-
Saline + epinephrine	Saline	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States