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NCT05753670
Effect of Preoperative Tamsulosin on Postoperative Urinary Retention
Conditions: Postoperative Retention of Urine
Sex: Female
Ages: 18 Years – 99 Years
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 160
Sponsor: NorthShore University HealthSystem
Location: United States
Summary
Approximately 25-30% of patients experience postoperative urinary retention after female pelvic surgery with mid-urethral sling placement.
These patients are discharged home with a foley catheter for a few days.
Despite being common, many patients consider being discharged home with a foley catheter as a complication of surgery and as the worst part of their experience.
Previous studies have demonstrated that 3-5 days of preoperative tamsulosin (a safe and low-cost medication) have been shown to improve postoperative urinary retention rates.
Although it takes tamsulosin 5 days to reach a steady-state in a patient, it reaches peak blood volume in 4-5 hours in a fasting patient.
The effect of a single dose of preoperative tamsulosin on postoperative urinary retention has not been studied, however would be substantially easier for patients than multiple days of preoperative doses.
In this study, the investigators would like to give patients preoperative tamsulosin versus placebo.
The investigators would then evaluate for postoperative urinary retention.
Previous studies have demonstrated a postoperative urinary retention rate decrease of 65-88% after various tamsulosin protocols.
However, the effect of single preoperative dose of tamusloin on postoperative urinary retention has yet to be studied in female pelvic surgery.
The investigators hypothesize that a single preoperative dose of tamsulosin will decrease the number of patients with postoperative urinary retention and therefore discharged with a foley catheter.
Our goal is to improve patient outcomes and satisfaction postoperatively.
Eligibility Criteria
Inclusion Criteria:Mid-urethral sling placementExclusion Criteria:Age <18Planned combined cases with colorectal surgery, general surgery, or gynecology-oncologyPlanned sling revision or history of prior sling placementKnown history of urinary retentionConcomitant intravesical botulinum injectionsConcomitant prolapse surgeryKnown contraindication to tamsulosin
Source: ClinicalTrials.gov (NCT05753670). StuddyBuddy aggregates publicly available trial information.