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

October 29, 2018 updated by: Michael Flynn, University of Massachusetts, Worcester
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine + epinephrine
Drug: Epinephrine
1:200,000 epinephrine
Drug: Bupivacaine
10ml 0.5% bupivacaine
Other Names:
  • Marcaine
Placebo Comparator: Saline + epinephrine
Drug: Saline
10ml 0.9% sodium chloride
Other Names:
  • Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling
Time Frame: 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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain Scores at 2-3 Hours Post op
Time Frame: 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)
2-3 hours
Post-operative Pain Scale at 6-7 Hours Post op
Time Frame: 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)
6-7 hours
Visual Analog Scale for Pain: Pre-operative.
Time Frame: 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.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Michael Flynn, MD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Urinary Incontinence

Clinical Trials on Epinephrine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe