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

Sponsor
University of Massachusetts, Worcester (Other)
Overall Status
Completed
CT.gov ID
NCT01583166
Collaborator
(none)
90
1
2
50
1.8

Study Details

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 Phase
N/A

Study Design

Study Type:
Interventional
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 :
Mar 1, 2012
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupivacaine + epinephrine

Drug: Bupivacaine
10ml 0.5% bupivacaine
Other Names:
  • Marcaine
  • Drug: Epinephrine
    1:200,000 epinephrine

    Placebo Comparator: Saline + epinephrine

    Drug: Saline
    10ml 0.9% sodium chloride
    Other Names:
  • Sodium Chloride
  • Outcome Measures

    Primary Outcome Measures

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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Flynn, Principal Investigator, University of Massachusetts, Worcester
    ClinicalTrials.gov Identifier:
    NCT01583166
    Other Study ID Numbers:
    • 14197
    First Posted:
    Apr 23, 2012
    Last Update Posted:
    Nov 28, 2018
    Last Verified:
    Oct 1, 2018

    Study Results

    Participant Flow

    Recruitment Details Subjects with stress incontinence or stress-predominant mixed urinary incontinence who were scheduled to undergo a retropubic midurethral sling with no concomitant procedures at UMass Memorial Healthcare, Inc. Enrollment occurred from March 2012 to June 2015 with study presented and consent sought at time of preoperative appointment.
    Pre-assignment Detail 10 participants did not receive allocated intervention--patient-initiated cancellation of surgery. (Saline + Epinephrine n=6, Bupivavane + Epinephrine n=4). Midway through study, indigo carmine became unavailable and surgical team opted for phenazopyridine. Failed to obtain 6-7 hour pain score in 24 out of 80 subjects.
    Arm/Group Title Marcaine + Epinephrine Saline + Epinephrine
    Arm/Group Description Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
    Period Title: Overall Study
    STARTED 45 45
    COMPLETED 41 39
    NOT COMPLETED 4 6

    Baseline Characteristics

    Arm/Group Title Marcaine + Epinephrine Saline + Epinephrine Total
    Arm/Group Description Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine Total of all reporting groups
    Overall Participants 41 39 80
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.0
    (11.6)
    50.5
    (11.1)
    48.1
    (11.3)
    Sex: Female, Male (Count of Participants)
    Female
    41
    100%
    39
    100%
    80
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    41
    100%
    39
    100%
    80
    100%
    Visual Analog Scale for Pain: Preoperative (Units on a Scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Units on a Scale]
    0.0
    (1)
    0.0
    (1.4)
    0.0
    (1.2)

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Passed void trial
    Arm/Group Title Marcaine + Epinephrine Saline + Epinephrine
    Arm/Group Description Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
    Measure Participants 41 39
    Count of Participants [Participants]
    31
    75.6%
    32
    82.1%
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Please notice that the number of subjects is different because we only analyzed the pain scores from the subjects who were randomized and had the surgery. We also had some missing pain scores
    Arm/Group Title Marcaine + Epinephrine Saline + Epinephrine
    Arm/Group Description Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
    Measure Participants 41 39
    Mean (Standard Deviation) [units on a scale]
    3
    (2)
    2.9
    (2.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Marcaine + Epinephrine, Saline + Epinephrine
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.837
    Comments
    Method Fisher Exact
    Comments
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Study team failed to obtain 6-7 hour pain score for 24 out of the 80 participants. The overall number of participants analyzed reflects this occurence.
    Arm/Group Title Marcaine + Epinephrine Saline + Epinephrine
    Arm/Group Description Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
    Measure Participants 29 27
    Mean (Standard Deviation) [units on a scale]
    3.1
    (1.6)
    4.1
    (1.9)
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Please noticed that there is a discrepancy with the number of subjects. We include the data from all subjects who were randomized and had the intervention.
    Arm/Group Title Marcaine + Epinephrine Saline + Epinephrine
    Arm/Group Description Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
    Measure Participants 41 39
    Mean (Standard Deviation) [Reported Pain Level score on VAS]
    0.0
    (1)
    0.0
    (1.4)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Marcaine + Epinephrine Saline + Epinephrine
    Arm/Group Description Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
    All Cause Mortality
    Marcaine + Epinephrine Saline + Epinephrine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/45 (0%) 0/45 (0%)
    Serious Adverse Events
    Marcaine + Epinephrine Saline + Epinephrine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/45 (0%) 0/45 (0%)
    Other (Not Including Serious) Adverse Events
    Marcaine + Epinephrine Saline + Epinephrine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/45 (0%) 0/45 (0%)

    Limitations/Caveats

    Failure to obtain 6-7 hour pain score for 24/80 participants. Impact of large preponderance of slings placed by a subrapublic approach. Study not designed to examine the effect of phenazopyridine in study.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Michael Flynn, MD
    Organization UMass Worcester
    Phone 508-334-9840
    Email michael.flynn@umassmemorial.org
    Responsible Party:
    Michael Flynn, Principal Investigator, University of Massachusetts, Worcester
    ClinicalTrials.gov Identifier:
    NCT01583166
    Other Study ID Numbers:
    • 14197
    First Posted:
    Apr 23, 2012
    Last Update Posted:
    Nov 28, 2018
    Last Verified:
    Oct 1, 2018