Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

NCT06258785 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: EH23-402
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Urinary Retention

  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.

  Immediate postoperative evaluation (1 day)

Secondary Outcomes (2)

• Average Postoperative Pain Score

  Immediate postoperative evaluation (1 day)

• Number of Participants With Postoperative Unanticipated Healthcare Encounters

  30 days

Study Arms (1)

Tizanidine

EXPERIMENTAL

Tizanidine 2mg will be given preoperatively prior to scheduled sacrospinous ligament suspension

Drug: Tizanidine

Interventions

Tizanidine DRUG

Tizanidine 2mg will be given preoperatively prior to scheduled sacrospinous ligament suspension

Also known as: Zanaflex

Tizanidine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: This intervention is applicable for persons assigned female at birth undergoing sacrospinous ligament suspension for pelvic organ prolapse.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sacrospinous ligament suspension (CPT 57282)

You may not qualify if:

• Age \<18
• Planned combined cases with colorectal surgery, general surgery, or gynecology-oncology
• Known history of urinary retention
• Known contraindication to tizanidine

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University Health System

Skokie, Illinois, 60076, United States

Location

Related Publications (13)

• Wang R, Won S, Haviland MJ, Von Bargen E, Hacker MR, Li J, Lefevre R. Voiding trial outcome following pelvic floor repair without incontinence procedures. Int Urogynecol J. 2016 Aug;27(8):1215-20. doi: 10.1007/s00192-016-2975-y. Epub 2016 Feb 17.

  PMID: 26886553 BACKGROUND

• Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.

  PMID: 21860294 BACKGROUND

• Willis-Gray MG, Wu JM, Field C, Pulliam S, Husk KE, Brueseke TJ, Geller EJ, Connolly A, Dieter AA. Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e256-e260. doi: 10.1097/SPV.0000000000000743.

  PMID: 31157716 BACKGROUND

• Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.

  PMID: 20727543 BACKGROUND

• Pomajzl AJ, Siref LE. Postoperative Urinary Retention. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK549844/

  PMID: 31751034 BACKGROUND

• Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.

  PMID: 14710061 BACKGROUND

• Lovatsis D, Drutz HP. Safety and efficacy of sacrospinous vault suspension. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(5):308-13. doi: 10.1007/s001920200067.

  PMID: 12355291 BACKGROUND

• Kondo W, Correa Leite GK, Fernandes R, Kamergorodsky G, Fin FR, Cordeiro Fernandes LF, Romeo A, Tessmann Zomer M. Useful Pelvic Retroperitoneal Neuroanatomy for Benign Gynecologic Surgery: A Cadaveric Dissection. J Minim Invasive Gynecol. 2021 Jan;28(1):20-21. doi: 10.1016/j.jmig.2020.05.013. Epub 2020 May 22.

  PMID: 32450223 BACKGROUND

• Roshanravan SM, Wieslander CK, Schaffer JI, Corton MM. Neurovascular anatomy of the sacrospinous ligament region in female cadavers: Implications in sacrospinous ligament fixation. Am J Obstet Gynecol. 2007 Dec;197(6):660.e1-6. doi: 10.1016/j.ajog.2007.08.061.

  PMID: 18060971 BACKGROUND

• Ghanavatian S, Derian A. Tizanidine. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519505/

  PMID: 30137790 BACKGROUND

• Lovich-Sapola J, Smith CE, Brandt CP. Postoperative pain control. Surg Clin North Am. 2015 Apr;95(2):301-18. doi: 10.1016/j.suc.2014.10.002. Epub 2015 Jan 24.

  PMID: 25814108 BACKGROUND

• Schug SA, Chong C. Pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2009 Dec;22(6):738-43. doi: 10.1097/ACO.0b013e32833020f4.

  PMID: 19606022 BACKGROUND

• Collins SA, Joshi G, Quiroz LH, Steinberg AC, Nihira MA. Pain management strategies for urogynecologic surgery: a review. Female Pelvic Med Reconstr Surg. 2014 Nov-Dec;20(6):310-5. doi: 10.1097/SPV.0000000000000134.

  PMID: 25185632 BACKGROUND

MeSH Terms

Interventions

tizanidine

Results Point of Contact

• Title: Dr. Claudia Paya Ten
• Organization: Endeavor Health

claudia.payaten@endeavorhealth.org

847-570-4729

Study Officials

• Claudia Paya Ten, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endeavor Health Urogynecology Fellow

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: September 17, 2024
• Primary Completion: September 15, 2025
• Study Completion: October 24, 2025
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

Locations

US (1)