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Completed

NCT Number: NCT01583166

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

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

10ml 0.5% bupivacaine

Other names: Marcaine

Saline

Drug

10ml 0.9% sodium chloride

Other names: Sodium Chloride

Epinephrine

Drug

1:200,000 epinephrine

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Acronym: URINE&ME

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2012
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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