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Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

Effect of Pre-operative Tizanidine on Postoperative Urinary Retention After Sacrospinous Vaginal Vault Suspension: a Pilot Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06258785
Enrollment
20
Registered
2024-02-14
Start date
2024-09-17
Completion date
2025-10-24
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed description

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.

Interventions

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

Sponsors

Endeavor Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Postoperative Urinary RetentionImmediate postoperative evaluation (1 day)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.

Secondary

MeasureTime frameDescription
Average Postoperative Pain ScoreImmediate postoperative evaluation (1 day)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.
Number of Participants With Postoperative Unanticipated Healthcare Encounters30 daysDetermine 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Tizanidine
Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension.
20
Total20

Baseline characteristics

CharacteristicTizanidine
Age, Continuous69 years
STANDARD_DEVIATION 11
BMI28 kg/m^2
STANDARD_DEVIATION 7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Menopausal Status
Post-menopausal
19 Participants
Menopausal Status
Pre-menopausal
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
19 Participants
Sex: Female, Male
Female
20 Participants
Sex: Female, Male
Male
0 Participants
Smoking Status
Current smoker
1 Participants
Smoking Status
Non-smoker
14 Participants
Smoking Status
Prior smoker
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

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.

Time frame: Immediate postoperative evaluation (1 day)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TizanidineNumber of Participants With Postoperative Urinary Retention11 Participants
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.

Time frame: Immediate postoperative evaluation (1 day)

ArmMeasureValue (MEAN)Dispersion
TizanidineAverage Postoperative Pain Score3 score on a scaleStandard Deviation 3
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.

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TizanidineNumber of Participants With Postoperative Unanticipated Healthcare Encounters1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026