The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling

Last updated: February 5, 2024
Sponsor: West Penn Allegheny Health System
Overall Status: Active - Recruiting

Phase

4

Condition

Genitourinary Prolapse

Enuresis

Urinary Incontinence

Treatment

Normal saline with epinephrine

lidocaine with epinephrine

Clinical Study ID

NCT03913845
Retropubic Lidocaine vs Saline
  • Ages 18-99
  • Female
  • Accepts Healthy Volunteers

Study Summary

Stress urinary incontinence affects millions of women worldwide and has a profound impact on the quality of life of older individuals, their subjective health status, levels of depression and need for care. Midurethral sling placement was introduced in 1995 and remains the current gold standard for surgical management of SUI. Although the advantages of midurethral sling surgery include its high success and minimally invasive approach, approximately 10-50% of women experience acute postoperative urinary retention and are subsequently sent home with an indwelling foley catheter or clean intermittent self catheterization. Urinary retention is anxiety provoking for most patients and adds morbidity, cost, and increased utilization of healthcare resources. Additionally, catheterization of the urinary tract results in increased risk of urinary tract infection and potential need for antibiotics.

Several recent studies have reported varying rates of postoperative voiding trial success depending on the type of local anesthetic used for hydrodissection; however the data is sparse and invites a more thorough investigation. Furthermore, to the investigators knowledge, no studies have systematically explored dosage or type of agent used intraoperatively on postoperative voiding function. Based on the preliminary data, the investigators hypothesize that patients receiving normal saline compared to a local anesthetic (e.g., lidocaine) will have a reduction in duration of postoperative urinary retention following retropubic midurethral sling placement.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older
  • English speaking
  • Competent to give consent

Exclusion

Exclusion Criteria:

  • A known intolerance or allergic reaction to local anesthetics
  • Planned spinal anesthesia for the procedure
  • Planned concomitant prolapse repair other than anterior repair
  • Preoperative voiding dysfunction as evidenced by a postvoid residual (PVR) of 150 mLor greater.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Normal saline with epinephrine
Phase: 4
Study Start date:
November 25, 2019
Estimated Completion Date:
December 31, 2025

Study Description

Aim 1: to compare the incidence of urinary retention following retropubic midurethral sling placement in those women receiving normal saline vs lidocaine for retropubic hydrodissection. The investigators will compare rates of failed retrograde voiding trials between patients receiving normal saline to those receiving the same quantity of lidocaine. This will be completed using a standardized retrograde voiding trial 1-2 hours postoperatively (as outlined in "Data and Statistical Methods" below). The investigators hypothesize that patients receiving normal saline compared to a local anesthetic will have a reduction in postoperative urinary retention following retropubic midurethral sling placement.

Aim 2: to assess postoperative pain in women receiving retropubic normal saline vs lidocaine during midurethral sling placement. Postoperatively, subjects will be asked to mark their pain on a VAS scale administered 2 hours and 6 hours following surgery. The initial assessment will be performed by nursing personnel at the time of routine vital sign assessment; the subsequent assessments will be completed by patients with an at-home form through postoperative day #7. Narcotic use will be queried through the electronic medical record as well as with a pain diary administered at time of discharge until postoperative day #7.

Aim 3: to examine differences in patient satisfaction and quality of life following retropubic midurethral sling placement between women receiving retropubic normal saline vs lidocaine at time of midurethral sling placement. Differences in patient satisfaction will be compared using a Likert Scale. Patients will be asked to rate their satisfaction with surgery on a Likert scale (with 1 being the least satisfied and 5 being the most) at their 6 week postoperative follow up visit. The investigators hypothesize that women receiving normal saline for hydrodissection will have improved patient satisfaction as evidenced by higher Likert scores compared to those receiving lidocaine.

Connect with a study center

  • AHN Bethel Park Health + Wellness Pavilion

    Bethel Park, Pennsylvania 15102
    United States

    Active - Recruiting

  • AHN Jefferson Hospital

    Jefferson Hills, Pennsylvania 15025
    United States

    Active - Recruiting

  • AHN West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • AHN Wexford Health + Wellness Pavilion

    Wexford, Pennsylvania 15090
    United States

    Active - Recruiting

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