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

Completed · Phase 4

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT03913845

Run by

West Penn Allegheny Health System

People needed

150

Starts

2019-11-25

Expected to finish

2024-11-14

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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 mL or greater.

Where it is running

• 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

Full record on ClinicalTrials.gov

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