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NCT05753670 · ClinicalTrials.gov registry record · Phase 3
Effect of Preoperative Tamsulosin on Postoperative Urinary Retention
A Phase 3 study, sponsored by Endeavor Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 179
- Enrollment target
NCT05753670 is a Phase 3 study that has completed, run by Endeavor Health. The registered enrollment target is 179 participants.
The verdict
NCT05753670, a Phase 3 study, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 179 participants
- Enrollment target
Study Summary
Approximately 25-30% of patients experience postoperative urinary retention after female pelvic surgery with mid-urethral sling placement. These patients are discharged home with a foley catheter for a few days. Despite being common, many patients consider being discharged home with a foley catheter as a complication of surgery and as the worst part of their experience. Previous studies have demonstrated that 3-5 days of preoperative tamsulosin (a safe and low-cost medication) have been shown to improve postoperative urinary retention rates. Although it takes tamsulosin 5 days to reach a steady-state in a patient, it reaches peak blood volume in 4-5 hours in a fasting patient. The effect of a single dose of preoperative tamsulosin on postoperative urinary retention has not been studied, however would be substantially easier for patients than multiple days of preoperative doses. In this study, the investigators would like to give patients preoperative tamsulosin versus placebo. The investigators would then evaluate for postoperative urinary retention. Previous studies have demonstrated a postoperative urinary retention rate decrease of 65-88% after various tamsulosin protocols. However, the effect of single preoperative dose of tamusloin on postoperative urinary retention has yet to be studied in female pelvic surgery. The investigators hypothesize that a single preoperative dose of tamsulosin will decrease the number of patients with postoperative urinary retention and therefore discharged with a foley catheter. Our goal is to improve patient outcomes and satisfaction postoperatively.
Interventions
- DRUG Placebo
- DRUG Tamsulosin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2024-06-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05753670
The ClinicalTrials.gov registry entry for NCT05753670 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05753670 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05753670 about?
NCT05753670 is a clinical study titled "Effect of Preoperative Tamsulosin on Postoperative Urinary Retention". Approximately 25-30% of patients experience postoperative urinary retention after female pelvic surgery with mid-urethral sling placement. These patients are discharged home with a foley catheter for a few days. Despite being common, many patients consider being discharged home with a foley catheter...
What is the current status of trial NCT05753670?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 179 participants. The study started on 2023-07-01. Estimated completion is 2024-06-02.
What interventions are being tested in trial NCT05753670?
The interventions under investigation include: Placebo (DRUG), Tamsulosin (DRUG).
Who is sponsoring clinical trial NCT05753670?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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