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Trial Outcomes & Findings for Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension (NCT NCT06258785)

NCT ID: NCT06258785

Last Updated: 2025-11-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

Immediate postoperative evaluation (1 day)

Results posted on

2025-11-24

Participant Flow

Participant milestones

Participant milestones
Measure
Tizanidine
Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension.
Overall Study
STARTED
20
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tizanidine
n=20 Participants
Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension.
Age, Continuous
69 years
STANDARD_DEVIATION 11 • n=45 Participants
Sex: Female, Male
Female
20 Participants
n=45 Participants
Sex: Female, Male
Male
0 Participants
n=45 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=45 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
n=45 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=45 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=45 Participants
Race (NIH/OMB)
Asian
1 Participants
n=45 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=45 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=45 Participants
Race (NIH/OMB)
White
19 Participants
n=45 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=45 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=45 Participants
Smoking Status
Non-smoker
14 Participants
n=45 Participants
Smoking Status
Prior smoker
5 Participants
n=45 Participants
Smoking Status
Current smoker
1 Participants
n=45 Participants
Menopausal Status
Pre-menopausal
1 Participants
n=45 Participants
Menopausal Status
Post-menopausal
19 Participants
n=45 Participants
BMI
28 kg/m^2
STANDARD_DEVIATION 7 • n=45 Participants

PRIMARY outcome

Timeframe: Immediate 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.

Outcome measures

Outcome measures
Measure
Tizanidine
n=20 Participants
Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension.
Number of Participants With Postoperative Urinary Retention
11 Participants

SECONDARY outcome

Timeframe: Immediate 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.

Outcome measures

Outcome measures
Measure
Tizanidine
n=20 Participants
Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension.
Average Postoperative Pain Score
3 score on a scale
Standard Deviation 3

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome measures
Measure
Tizanidine
n=20 Participants
Patients will receive a single preoperative dose of tizanidine 2mg in the preoperative holding area on the day of scheduled sacrospinous ligament suspension.
Number of Participants With Postoperative Unanticipated Healthcare Encounters
1 Participants

Adverse Events

Tizanidine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Claudia Paya Ten

Endeavor Health

Phone: 847-570-4729

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place