Skip to main content
OpenTrials
Completed

NCT Number: NCT04859660

Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Retention Postoperative

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Banner University Medical Center- Phoenix, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

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

Drug

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.

Primary outcomes

  1. Time to Spontaneous Void

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Time to Discharge From the Post-anesthesia Care Unit

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2021
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.