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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.
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%.
Each patient after surgery undergoes a "voiding trial" where their voided volume is compared to their post-void residual volume. "Passing" a voiding trial has traditionally been defined as voiding a greater volume than the post-void residual volume. If the patient does not "pass" the voiding trial, the patient is characterized as having postoperative urinary retention and is discharged home with an indwelling catheter to prevent detrusor injury from bladder over-distention, pain and urinary tract infection.
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.
The leading hypotheses regarding the incidence of postoperative urinary retention after sacrospinous ligament suspension includes postoperative pain and pelvic floor muscle spasm leading to retention. The sacrospinous suspension includes a suture that is passed through the sacrospinous ligament and, therefore, through the coccygeus muscle with irritation of the pudendal nerve. The pelvic floor is a synergistic team of muscles that work together to support the pelvic organs and spasm of the coccygeus muscle, rather than an isolated muscle, can cause spasm of the entirety of the pelvic floor leading to retention. 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.
Tizanidine is also frequently given for postoperative pain after sacrospinous ligament suspension and may act as an adjunct to a non-narcotic pain regimen to improve postoperative pain while reducing narcotic use after surgery. Postoperative buttock and posterior thigh pain are common symptoms after SSLF, with immediate pain reported in 6-84% of patients and persistent pain at 6 weeks occurring in 1-15%. Untreated acute postoperative pain has been shown to lead to increased morbidity and mortality. Pain is the most common reason for a postoperative unplanned hospital admission and poor postoperative pain control can lead to decreased ambulation, increased incidence of thromboembolism, and decreased inspiratory effort leading to postoperative pneumonia, therefore postoperative pain control is critical. In a country with rising narcotic-use and dependence, it is critical that we continue to explore non-narcotic alternatives for patients after surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tizanidine | Experimental | Tizanidine 2mg will be given preoperatively prior to scheduled sacrospinous ligament suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tizanidine | Drug | Tizanidine 2mg will be given preoperatively prior to scheduled sacrospinous ligament suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Postoperative Pain Score | Determine average postoperative pain score after postoperative administration of tizanidine utilizing a 10-point Likert scale for pain (0 = no pain, 10 = extreme pain). This data will be obtained by electronic data pull and chart review. | Immediate postoperative evaluation (1 day) |
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Inclusion Criteria:
Exclusion Criteria:
This intervention is applicable for persons assigned female at birth undergoing sacrospinous ligament suspension for pelvic organ prolapse.
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Paya Ten, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University Health System | Skokie | Illinois | 60076 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26886553 | Background | 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. | |
| 21860294 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tizanidine | Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tizanidine | Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Immediate postoperative evaluation (1 day) |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tizanidine | Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Claudia Paya Ten | Endeavor Health | 847-570-4729 | claudia.payaten@endeavorhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2025 | Nov 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C023754 | tizanidine |
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| Number of Participants With Postoperative Unanticipated Healthcare Encounters |
Determine the number of participants with postoperative unanticipated healthcare encounters, including readmissions, office visits or emergency department visit within 30 days after surgery. This data will be collected via chart review. |
| 30 days |
| 31157716 | 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. |
| 20727543 | 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. |
| Background | Pomajzl, A. J., and Larry E. Siref. "Post-Op Urinary Retention." StatPearls, StatPearls Publishing, 2022. PubMed, http://www.ncbi.nlm.nih.gov/books/NBK549844/ |
| 14710061 | 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. |
| 12355291 | 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. |
| 32450223 | 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. |
| 18060971 | 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. |
| 30137790 | Background | Ghanavatian S, Derian A. Tizanidine. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK519505/ |
| 25814108 | 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. |
| 19606022 | Background | Schug SA, Chong C. Pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2009 Dec;22(6):738-43. doi: 10.1097/ACO.0b013e32833020f4. |
| 25185632 | 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Smoking Status | Count of Participants | Participants |
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| Menopausal Status | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Units | Counts |
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| Participants |
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| Secondary | Average Postoperative Pain Score | Determine average postoperative pain score after postoperative administration of tizanidine utilizing a 10-point Likert scale for pain (0 = no pain, 10 = extreme pain). This data will be obtained by electronic data pull and chart review. | Posted | Mean | Standard Deviation | score on a scale | Immediate postoperative evaluation (1 day) |
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| Secondary | Number of Participants With Postoperative Unanticipated Healthcare Encounters | Determine the number of participants with postoperative unanticipated healthcare encounters, including readmissions, office visits or emergency department visit within 30 days after surgery. This data will be collected via chart review. | Posted | Count of Participants | Participants | 30 days |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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