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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Saline
Epinephrine
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Massachusetts

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine + epinephrine

Saline + epinephrine

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling
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

Post-operative Pain Scores at 2-3 Hours Post op
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)
Post-operative Pain Scale at 6-7 Hours Post op
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)
Visual Analog Scale for Pain: Pre-operative.
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.

Full Information

First Posted
April 19, 2012
Last Updated
October 29, 2018
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT01583166
Brief Title
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Acronym
URINE&ME
Official Title
Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine + epinephrine
Arm Type
Active Comparator
Arm Title
Saline + epinephrine
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
10ml 0.5% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Sodium Chloride
Intervention Description
10ml 0.9% sodium chloride
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
1:200,000 epinephrine
Primary Outcome Measure Information:
Title
Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Post-operative Pain Scores at 2-3 Hours Post op
Description
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)
Time Frame
2-3 hours
Title
Post-operative Pain Scale at 6-7 Hours Post op
Description
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)
Time Frame
6-7 hours
Title
Visual Analog Scale for Pain: Pre-operative.
Description
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.
Time Frame
At enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Flynn, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27682748
Citation
Duenas-Garcia OF, Patterson D, De la Luz Nieto M, Leung K, Flynn MK. Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):56-60. doi: 10.1097/SPV.0000000000000343.
Results Reference
derived

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Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

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