Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01583166
First received: April 19, 2012
Last updated: June 8, 2016
Last verified: June 2016
  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


Enrollment: 50
Study Start Date: March 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Michael Flynn, MD University of Massachusetts, Worcester
  More Information

Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01583166     History of Changes
Other Study ID Numbers: 14197 
Study First Received: April 19, 2012
Last Updated: June 8, 2016
Health Authority: United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Bupivacaine
Anesthetics, Local
Anesthetics
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on December 07, 2016