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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01583166
Recruitment Status : Completed
First Posted : April 23, 2012
Results First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Flynn, University of Massachusetts, Worcester

Study Description
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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 Phase
Stress Urinary Incontinence Drug: Bupivacaine Drug: Saline Drug: Epinephrine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 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
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bupivacaine + epinephrine Drug: Bupivacaine
10ml 0.5% bupivacaine
Other Name: Marcaine

Drug: Epinephrine
1:200,000 epinephrine
Placebo Comparator: Saline + epinephrine Drug: Saline
10ml 0.9% sodium chloride
Other Name: Sodium Chloride


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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)

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Michael Flynn, MD University of Massachusetts, Worcester
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Flynn, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01583166    
Other Study ID Numbers: 14197
First Posted: April 23, 2012    Key Record Dates
Results First Posted: November 28, 2018
Last Update Posted: November 28, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
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
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents