Status:
COMPLETED
Assessing Pyridium for Post-Sling Urinary Retention
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Urinary Retention
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
There has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. This study is designed to have two groups of patients. One group will recei...
Detailed Description
This is a prospective randomized controlled trial. It will have two arms with 48 patients in each arm, a total of 98 patients. Patients will be randomized with a block randomization schedule generated...
Eligibility Criteria
Inclusion
- Any female patient undergoing a midurethral sling surgery, regardless of concomitant pelvic reconstructive or gynecological surgery
Exclusion
- Patients with complications from surgery requiring indwelling catheter, bladder/urethral perforation requiring indwelling catheter
- Acute bleeding requiring indwelling catheter for accurate urine output calculation
- Patients undergoing concomitant surgery other than gynecological, preoperative voiding dysfunction defined as postvoid residual \>150cc, or spinal anesthesia
- Women who are pregnant, including women of childbearing age who test positive on preoperative urine pregnancy test
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03302936
Start Date
October 24 2017
End Date
July 1 2019
Last Update
October 29 2019
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029