Back to resultsPre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Primary Purpose
Urinary Retention Postoperative
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Retention Postoperative
Eligibility Criteria
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
Sites / Locations
- Banner University Medical Center- Phoenix
- Banner University Medical Center- Tucson
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tamsulosin- intervention group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
Time to spontaneous void
Secondary Outcome Measures
Time to discharge from the hospital
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04859660
Brief Title
Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Official Title
Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
June 24, 2023 (Actual)
Study Completion Date
June 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin- intervention group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Time to spontaneous void
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Time to discharge from the hospital
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Banner University Medical Center- Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Banner University Medical Center- Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
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