Text Size

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

This study is currently recruiting participants.
Verified May 2013 by University of Massachusetts, Worcester
Sponsor:
Information provided by (Responsible Party):
Danielle Patterson, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01583166
First received: April 19, 2012
Last updated: May 1, 2013
Last verified: May 2013
History of Changes

April 19, 2012
May 1, 2013
March 2012
April 2014   (final data collection date for primary outcome measure)
Voided volume and post-void residual [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
We will assess if 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.
Post-operative voiding function [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01583166 on ClinicalTrials.gov Archive Site
  • Post-operative pain [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Visual analog score at 2 hours post op will be compared in the two groups.
  • Post-operative pain [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Visual analog scale at 6 hours post-op will be compared in the two groups
Post-operative pain [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Stress Urinary Incontinence
  • Drug: Bupivicaine + epinephrine
    10ml 0.5% bupivicaine plus 1:200,000 epinephrine
  • Drug: Sodium chloride + epinephrine
    10ml 0.9% sodium chloride plus 1:200,000 epinephrine
  • Active Comparator: Marcaine + epinephrine
    Intervention: Drug: Bupivicaine + epinephrine
  • Placebo Comparator: Saline + epinephrine
    Intervention: Drug: Sodium chloride + epinephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Danielle Patterson, MD, MSc 508-334-9189 danielle.patterson@umassmemorial.org
Contact: Sharon Smith 508-334-6678 sharon.smith@umassmemorial.org
United States
 
NCT01583166
14197
Yes
Danielle Patterson, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Danielle Patterson, MD, MSc University of Massachusetts, Worcester
University of Massachusetts, Worcester
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP