RECRUITING

Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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%. 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.

Official Title

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

Quick Facts

Study Start:2024-09-17
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06258785

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Sacrospinous ligament suspension (CPT 57282)
  1. * Age \<18
  2. * Planned combined cases with colorectal surgery, general surgery, or gynecology-oncology
  3. * Known history of urinary retention
  4. * Known contraindication to tizanidine

Contacts and Locations

Study Contact

Angela Leffelman, MD
CONTACT
224-251-2374
ALeffelman@northshore.org
Jungeun Lee, MS
CONTACT
847-570-4729
JLee5@northshore.org

Principal Investigator

Angela Leffelman, MD
PRINCIPAL_INVESTIGATOR
NorthShore University HealthSystem

Study Locations (Sites)

NorthShore University Health System
Skokie, Illinois, 60076
United States

Collaborators and Investigators

Sponsor: NorthShore University HealthSystem

  • Angela Leffelman, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

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