Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery
NCT ID: NCT06843538
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
166 participants
INTERVENTIONAL
2025-02-03
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Study Arm
Tamsulosin
This intervention will investigate if tamsulosin will decrease postoperative urinary retention. Subjects will be directed to start taking the medication 5-7 days prior to their procedure; as previous studies have shown, this is when tamsulosin reaches its steady state. Patients will continue to take their assigned pills for 7 days postoperatively.
Control Arm
Placebo
This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.
Interventions
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Tamsulosin
This intervention will investigate if tamsulosin will decrease postoperative urinary retention. Subjects will be directed to start taking the medication 5-7 days prior to their procedure; as previous studies have shown, this is when tamsulosin reaches its steady state. Patients will continue to take their assigned pills for 7 days postoperatively.
Placebo
This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients already on an alpha blocker
* Baseline hypotension
* History of syncope
* Postural orthostatic tachycardia syndrome (POTS)
* Non-English speaker or interpreter unavailable for Spanish-speaking patient
* Impaired cognition impeding proper consenting
* Any other medical contraindication for tamsulosin use
* History of urinary retention requiring continuous or intermittent catheterization
* Patients consented for the study but then due to intraoperative complication, routine voiding trial no longer indicated due to requiring indwelling catheter or intermittent catheterization on discharge will be excluded from primary outcome analysis
* Pregnancy
18 Years
FEMALE
No
Sponsors
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TriHealth Inc.
OTHER
Responsible Party
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Locations
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TriHealth
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-108
Identifier Type: -
Identifier Source: org_study_id
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