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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 is a Phase 4 study that has completed, run by West Penn Allegheny Health System. The registered enrollment target is 150 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03913845
The ClinicalTrials.gov registry entry for NCT03913845 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is West Penn Allegheny Health System, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lidocaine with epinephrine is the first listed.
NCT03913845 reports 0 study locations.
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.
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