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

This study is currently recruiting participants.
Verified November 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: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Drug: Bupivicaine + epinephrine
Drug: Sodium chloride + epinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 160
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Marcaine + epinephrine Drug: Bupivicaine + epinephrine
10ml 0.5% bupivicaine plus 1:200,000 epinephrine
Placebo Comparator: Saline + epinephrine Drug: Sodium chloride + epinephrine
10ml 0.9% sodium chloride plus 1:200,000 epinephrine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583166

Contacts
Contact: Danielle Patterson, MD, MSc 508-334-9189 danielle.patterson@umassmemorial.org
Contact: Sharon Smith 508-334-6678 sharon.smith@umassmemorial.org

Locations
United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Principal Investigator: Danielle Patterson, MD MSc         
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Danielle Patterson, MD, MSc University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Danielle Patterson, Assistant Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01583166     History of Changes
Other Study ID Numbers: 14197
Study First Received: April 19, 2012
Last Updated: November 5, 2013
Health Authority: United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Urination Disorders
Urinary Incontinence
Urinary Incontinence, Stress
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Epinephrine
Epinephryl borate
Bupivacaine
Anesthetics, Local
Anesthetics
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 14, 2014