Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT03302936
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 receive pyridium pre-operatively, while the other group will have routine preoperative care. Both groups will have their bladder tested prior to going home. It will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.
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Notify Me18 year and older
Female
Interventional
Phase 4
New York, 10029, United States
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 by computerized random numbers using a 1:1 allocation to pyridium and routine perioperative care. The study is powered to see a difference in incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling, the patient will have an active voiding trial performed as described by Pulvino et al. The patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed 20 minutes to void. The patient must void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial. The timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of concomitant surgery, the patient being alert, ambulating, with tolerable pain.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
to be given preoperatively
Other names: Pyridium
Time frame: Day 1
Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
Time frame: Day 1
Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
Time frame: Day 1: 6-8 hours after surgery
Pain scale from 0-10. 0-being no pain, 10-being the most pain
Icahn School of Medicine at Mount Sinai
Other
A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention
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