Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders
NCT ID: NCT04232683
Last Updated: 2025-05-21
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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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
100 participants
INTERVENTIONAL
2019-12-18
2025-12-31
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
SINGLE
Study Groups
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Preoperative Tamsulosin
The study group will receive one oral dose .4mg of Tamsulosin prior to surgery.
Tamsulosin 0.4Mg Capsule
Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased
Preoperative Placebo
The control group will receive one oral dose of placebo pill prior to surgery.
Placebo oral tablet
Placebo pill given preoperatively
Interventions
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Tamsulosin 0.4Mg Capsule
Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased
Placebo oral tablet
Placebo pill given preoperatively
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings
Exclusion Criteria
ii. Malignancy
iii. History of neurological disease
iv. History of spinal cord injuries
v. Allergy to Tamsulosin
vi. Perioperative complications requiring prolonged postoperative bladder drainage
vii. Incontinence procedures other than mid-urethral slings
FEMALE
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Eric Hurtado
Principal Investigator
Locations
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Cleveland Clinic Florida
Weston, Florida, United States
Countries
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Other Identifiers
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FLA 19-073
Identifier Type: -
Identifier Source: org_study_id
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