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Phase 4 N=150 Randomized Quadruple-blind Prevention

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

Stress Urinary Incontinence

Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Number of Subjects With Urinary Retention — 15; 14 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
lidocaine with epinephrine (Drug); Normal saline with epinephrine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
West Penn Allegheny Health System
Primary completion
Nov 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Urinary Retention
15; 14
SECONDARY
Postoperative Pain: VAS Scale
11; 21; 18; 25

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 Criteria

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

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 mL or greater.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03913845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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