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NCT03913845 · ClinicalTrials.gov registry record · Phase 4
The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling
A Phase 4 study, sponsored by West Penn Allegheny Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT03913845: Completed Phase 4 study, sponsored by West Penn Allegheny Health System.
NCT03913845 is a Phase 4 study that has completed, run by West Penn Allegheny Health System. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03913845, a Phase 4 study, has completed, sponsored by West Penn Allegheny Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study 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.
Primary Outcome
To compare the number of subjects with urinary retention following retropubic midurethral sling placement in those women receiving normal saline vs lidocaine for retropubic hydrodissection.
Interventions
- DRUG lidocaine with epinephrine
- DRUG Normal saline with epinephrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-11-25 |
| Est. Completion | 2024-11-14 |
| Phase | Phase 4 |
What the finished NCT03913845 record still lists
NCT03913845 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which lidocaine with epinephrine is the first listed.
NCT03913845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03913845 about?
NCT03913845 is a clinical study titled "The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling". 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 ...
What is the current status of trial NCT03913845?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2019-11-25. Estimated completion is 2024-11-14.
What interventions are being tested in trial NCT03913845?
The interventions under investigation include: lidocaine with epinephrine (DRUG), Normal saline with epinephrine (DRUG).
Who is sponsoring clinical trial NCT03913845?
This trial is sponsored by West Penn Allegheny Health System, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03913845's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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