Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial (URINE&ME)

University of Massachusetts, Worcester

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Drug: Bupivacaine; Drug: Epinephrine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01583166

14197

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Bupivacaine + epinephrine

Active Comparator group

Treatment:

Drug: Epinephrine

Drug: Bupivacaine

Saline + epinephrine

Placebo Comparator group

Treatment:

Drug: Saline