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Clinical trial

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

ID
Name
2102483026
Description
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 arms
Trial start
2021-04-16
Estimated PCD
2023-06-24
Trial end
2023-06-24
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Tamsulosin- intervention group
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.
Arms:
Placebo group
Size
161
Primary endpoint
Time to Spontaneous Void
8 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 161, 'type': 'ACTUAL'}}
Updated at
2024-02-29

1 organization

2 products

1 indication

Organization
University of Arizona
Product
Tamsulosin
Indication
Postoperative Urinary Retention
Product
Placebo