Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial
1 other identifier
interventional
161
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2021
CompletedFirst Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2023
CompletedResults Posted
Study results publicly available
February 29, 2024
CompletedFebruary 29, 2024
June 1, 2023
2.2 years
April 20, 2021
July 19, 2023
February 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Time to Discharge From the Post-anesthesia Care Unit
8 weeks
Study Arms (2)
Tamsulosin- intervention group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Women 18-80 undergoing outpatient minimally invasive hysterectomy
You may not qualify if:
- Inability to provide informed consent
- Bladder malignancy
- Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization
- Plan for sling or anterior repair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Banner University Medical Center- Phoenix
Phoenix, Arizona, 85006, United States
Banner University Medical Center- Tucson
Tucson, Arizona, 85718, United States
Related Publications (1)
Gabra M, Hall C, McCann L, Shah J, Jones I, Masjedi A, Runke S, Hsu CH, Aguirre A. Tamsulosin and Time to Spontaneous Void After Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2024 Dec 1;144(6):810-816. doi: 10.1097/AOG.0000000000005724. Epub 2024 Sep 12.
PMID: 39265173DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Martina Gabra
- Organization
- University of Arizona
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2021
First Posted
April 26, 2021
Study Start
April 16, 2021
Primary Completion
June 24, 2023
Study Completion
June 24, 2023
Last Updated
February 29, 2024
Results First Posted
February 29, 2024
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share