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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

ClinicalTrials.gov ID: NCT06258785

Public ClinicalTrials.gov record NCT06258785. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 3:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06258785
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Endeavor Health
Other
Enrollment
20 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 16, 2024
Primary completion
Sep 14, 2025
Completion
Oct 23, 2025
Last update posted
Nov 23, 2025

2024 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
NorthShore University Health System Skokie Illinois 60076

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06258785, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 23, 2025 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06258785 live on ClinicalTrials.gov.

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