Clinical trial NCT03302936: Assessing Pyridium for Post-Sling Urinary Retention
Official title: A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Retention
Keywords: Midurethral sling
Pyridium
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Any female patient undergoing a midurethral sling surgery, regardless of concomitant pelvic reconstructive or gynecological surgery

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Considered to Have Passed Their Voiding Trial
timeFrame: Day 1
measure: Incidence of Urinary Retention
timeFrame: Day 1
Secondary outcomes:
measure: Pain Scale
timeFrame: Day 1: 6-8 hours after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Charles Ascher-Walsh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: