Using Tizanidine to Reduce Urinary Retention After Pelvic Surgery
Effect of Pre-operative Tizanidine on Postoperative Urinary Retention After Sacrospinous Vaginal Vault Suspension: a Pilot Study
This study is testing if the muscle relaxant Tizanidine can help women who have surgery for pelvic issues avoid problems with urinating afterward.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Skokie, Illinois) |
| Trial ID | NCT06258785 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effect of Tizanidine, a muscle relaxant, on postoperative urinary retention in women undergoing sacrospinous vaginal vault suspension. Postoperative urinary retention is a common complication, affecting 30-60% of patients, and can lead to the need for indwelling catheters, which are associated with discomfort and increased risk of urinary tract infections. Participants will undergo a voiding trial after surgery to assess their ability to void, and those who do not pass will be treated with Tizanidine to potentially improve their outcomes. The goal is to reduce the incidence of urinary retention and improve patient satisfaction post-surgery.
Who should consider this trial
Good fit: Ideal candidates are women undergoing sacrospinous ligament suspension for pelvic reconstructive surgery.
Not a fit: Patients with a known history of urinary retention or contraindications to Tizanidine will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for indwelling catheters and improve recovery experiences for patients after pelvic reconstructive surgery.
How similar studies have performed: While the use of Tizanidine for this specific purpose is novel, similar interventions targeting postoperative complications have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Skokie, Illinois
- NorthShore University Health System — Skokie, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Angela Leffelman, MD — Endeavor Health
- Study coordinator: Angela Leffelman, MD
- Email: ALeffelman@northshore.org
- Phone: 224-251-2374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.