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Phase 3 N=20 Prevention

Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

Postoperative Urinary Retention · Sacrospinous Vaginal Vault Suspension · Reconstructive Pelvic Surgery

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Number of Participants With Postoperative Urinary Retention — 11 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Tizanidine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Endeavor Health
Primary completion
Sep 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Postoperative Urinary Retention
11
SECONDARY
Average Postoperative Pain Score
3
SECONDARY
Number of Participants With Postoperative Unanticipated Healthcare Encounters
1

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.

Eligibility Criteria

Inclusion Criteria

  • Sacrospinous ligament suspension (CPT 57282)

Exclusion Criteria

  • Age <18
  • Planned combined cases with colorectal surgery, general surgery, or gynecology-oncology
  • Known history of urinary retention
  • Known contraindication to tizanidine
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06258785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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