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NCT06258785 · ClinicalTrials.gov registry record · Phase 3
Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension
A Phase 3 study, sponsored by Endeavor Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT06258785 is a Phase 3 study that has completed, run by Endeavor Health. The registered enrollment target is 20 participants.
The verdict
NCT06258785, a Phase 3 study, has completed, sponsored by Endeavor Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
Postoperative urinary retention has been defined as the inability to void despite having fluid in the bladder during the postoperative period. Urinary retention after pelvic reconstructive surgery requiring indwelling catheter or self-catheterization usage occurs in approximately 30-60% of patients postoperatively. Our prior retrospective chart review reviewing postoperative urinary retention rates after pelvic reconstructive surgery demonstrated postoperative urinary retention after a sacrospinous vaginal vault suspension to be approximately 78.9%. Many women consider being discharged home with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery. Indwelling catheters are the leading cause of hospital-acquired urinary tract infections (UTIs), are often a source of embarrassment and inconvenience for patients, and often require additional office visits and healthcare utilization. Tizanidine is a muscle relaxant which can work to alleviate this spasm and, theoretically, prevent postoperative urinary retention. Tizanidine also works as an alpha-adrenergic receptor blocker which can increase smooth muscle relaxation around the urethra specifically and, theoretically, improve urine flow. Postoperative urinary retention is extremely common after pelvic reconstructive surgery involving a sacrospinous vaginal vault suspension and is extremely bothersome to patients. Tizanidine is a low-risk, well tolerated, cost-effective medication. No study to date has evaluated preoperative administration of tizanidine for postoperative urinary retention.
Interventions
- DRUG Tizanidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2025-10-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06258785
The ClinicalTrials.gov registry entry for NCT06258785 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 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 1 intervention - of which Tizanidine is the first listed.
NCT06258785 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06258785 about?
NCT06258785 is a clinical study titled "Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension". Postoperative urinary retention has been defined as the inability to void despite having fluid in the bladder during the postoperative period. Urinary retention after pelvic reconstructive surgery requiring indwelling catheter or self-catheterization usage occurs in approximately 30-60% of patients ...
What is the current status of trial NCT06258785?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2024-09-17. Estimated completion is 2025-10-24.
What interventions are being tested in trial NCT06258785?
The interventions under investigation include: Tizanidine (DRUG).
Who is sponsoring clinical trial NCT06258785?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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