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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: Completed Phase 3 study, sponsored by Endeavor Health.
NCT06258785 is a Phase 3 study that has completed, run by Endeavor Health. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine the postoperative urinary retention rates in patients undergoing a sacrospinous ligament suspension after postoperative administration of tizanidine. This will be determined immediately postoperative in the postoperative recovery room based on whether patients pass or fail their voiding trial described above. The result will be documented in electronic medical records and obtained from chart review.
Interventions
- DRUG Tizanidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2025-10-24 |
| Phase | Phase 3 |
What the finished NCT06258785 record still lists
NCT06258785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Tizanidine is the first listed.
NCT06258785 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06258785's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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