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

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ClinicalTrials.gov Identifier: NCT01583166
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Stress Urinary Incontinence Drug: Bupivicaine + epinephrine Drug: Sodium chloride + epinephrine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Study Start Date : March 2012
Primary Completion Date : May 2016
Study Completion Date : May 2016


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Voided volume and post-void residual [ Time Frame: 2 weeks ]
    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 :
  1. Post-operative pain [ Time Frame: 2 hours ]
    Visual analog score at 2 hours post op will be compared in the two groups.

  2. Post-operative pain [ Time Frame: 6 hours ]
    Visual analog scale at 6 hours post-op will be compared in the two groups


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Michael Flynn, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01583166     History of Changes
Other Study ID Numbers: 14197
First Posted: April 23, 2012    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

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