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

NCT01583166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-11-28

Study results available
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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.

Conditions

  • Stress Urinary Incontinence

Interventions

DRUG

Bupivacaine

10ml 0.5% bupivacaine

DRUG

Saline

10ml 0.9% sodium chloride

DRUG

Epinephrine

1:200,000 epinephrine

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Michael Flynn, MD · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583166 on ClinicalTrials.gov