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The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling
Sponsor: West Penn Allegheny Health System
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.
Official title: The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling: A Randomized Placebo Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2019-11-25
Completion Date
2024-11-14
Last Updated
2026-04-30
Healthy Volunteers
Yes
Conditions
Interventions
lidocaine with epinephrine
One of the most commonly used local anesthetic agents in surgical practice is lidocaine. Lidocaine as a local anesthetic is characterized by a rapid onset of action (typically within 2-5 minutes of injection) and intermediate duration of efficacy and thus is often favored in the outpatient setting for pre-incisional injections. Of note, however, its effects general only last up to 2 hours. Epinephrine (adrenaline) vasoconstricts arteries, delaying the resorption of lidocaine, and thus almost doubles the duration of anesthesia.
Normal saline with epinephrine
Several mechanisms could explain the inability to void postoperatively, including nerve conduction impairment from anesthesia. Multiple studies have investigated the use of various types of anesthesia and downstream effects on postoperative urinary retention. It is postulated that denervating the regional pelvic nerves for pain control may lead to denervation of the bladder for a transient period of time, block both the afferent and efferent pathways of the voiding mechanism, affect the urethral retro-resistance pressure and impact urethral length thereby contributing to voiding dysfunction postoperatively. The use of normal saline in this setting may have a reduction in rates and duration of postoperative urinary retention following retropubic midurethral sling placement.
Locations (4)
AHN Bethel Park Health + Wellness Pavilion
Bethel Park, Pennsylvania, United States
AHN Jefferson Hospital
Jefferson Hills, Pennsylvania, United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States
AHN Wexford Health + Wellness Pavilion
Wexford, Pennsylvania, United States