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NCT04859660 Clinical Trial

Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy

Urinary Retention Postoperative Clinical Trial

Official title:
Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04859660
Other study ID # 2102483026
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 16, 2021
Est. completion date June 24, 2023

Study information
Verified date June 2023
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date June 24, 2023
Est. primary completion date June 24, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Women 18-80 undergoing outpatient minimally invasive hysterectomy Exclusion Criteria: - Inability to provide informed consent - Bladder malignancy - Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization - Plan for sling or anterior repair

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tamsulosin
Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.
• Placebo
Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.

Locations
Country Name City State
United States Banner University Medical Center- Phoenix Phoenix Arizona
United States Banner University Medical Center- Tucson Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Spontaneous Void Each participant underwent a void trial post-operatively by backfilling their bladder with 200cc normal saline at the conclusion of the case and removing the foley. Patients needed to void at least 100cc to be considered to have "passed" their void trial. 8 weeks
Secondary Time to Discharge From the Post-anesthesia Care Unit The time from the patient leaving the OR to the time they were discharged home from the Post-anesthesia care unit was recorded to determine the Time to discharge. 8 weeks
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