Comparing lidocaine and saline for urinary retention after midurethral sling surgery
The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling: A Randomized Placebo Controlled Trial
This study is testing whether using lidocaine instead of saline after midurethral sling surgery can help women avoid urinary retention and feel better afterward.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | West Penn Allegheny Health System Academic / other |
| Locations | 4 sites (Bethel Park, Pennsylvania and 3 other locations) |
| Trial ID | NCT03913845 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of retropubic lidocaine versus normal saline on the incidence of postoperative urinary retention in women undergoing midurethral sling placement for stress urinary incontinence. The study will compare the rates of failed retrograde voiding trials between the two groups, hypothesizing that lidocaine will result in lower urinary retention rates. Additionally, it will assess postoperative pain levels and patient satisfaction through various assessments conducted in the days following surgery. The trial will involve a standardized approach to measure outcomes and gather data on narcotic use and quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 years or older who are English-speaking and competent to give consent.
Not a fit: Patients with known allergies to local anesthetics or those with preoperative voiding dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced urinary retention rates for women undergoing midurethral sling surgery.
How similar studies have performed: Other studies have explored similar interventions, but the specific comparison of lidocaine versus saline in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethel Park, Pennsylvania and 3 other locations
- AHN Bethel Park Health + Wellness Pavilion — Bethel Park, Pennsylvania, United States (Recruiting)
- AHN Jefferson Hospital — Jefferson Hills, Pennsylvania, United States (Recruiting)
- AHN West Penn Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- AHN Wexford Health + Wellness Pavilion — Wexford, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Lindsay Turner, MD — Department of Obstetrics and Gynecology, Allegheny Health Network
- Study coordinator: Caitlyn Copp-Millward
- Email: Caitlyn.Copp-millward@AHN.ORG
- Phone: 412-578-4368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.