COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling: A Randomized Placebo Controlled Trial

Quick Facts

Study Start:2019-11-25
Study Completion:2024-11-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03913845

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * English speaking
  3. * Competent to give consent
  1. * A known intolerance or allergic reaction to local anesthetics
  2. * Planned spinal anesthesia for the procedure
  3. * Planned concomitant prolapse repair other than anterior repair
  4. * Preoperative voiding dysfunction as evidenced by a postvoid residual (PVR) of 150 mL or greater.

Contacts and Locations

Principal Investigator

Lindsay Turner, MD
PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Allegheny Health Network

Study Locations (Sites)

AHN Bethel Park Health + Wellness Pavilion
Bethel Park, Pennsylvania, 15102
United States
AHN Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
AHN Wexford Health + Wellness Pavilion
Wexford, Pennsylvania, 15090
United States

Collaborators and Investigators

Sponsor: West Penn Allegheny Health System

  • Lindsay Turner, MD, PRINCIPAL_INVESTIGATOR, Department of Obstetrics and Gynecology, Allegheny Health Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-25
Study Completion Date2024-11-14

Study Record Updates

Study Start Date2019-11-25
Study Completion Date2024-11-14

Terms related to this study

Additional Relevant MeSH Terms

  • Stress Urinary Incontinence