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Completed

NCT Number: NCT03302936

Assessing Pyridium for Post-Sling Urinary Retention

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenazopyridine

Drug

to be given preoperatively

Other names: Pyridium

Primary outcomes

  1. Number of Participants Considered to Have Passed Their Voiding Trial

    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.

  2. Incidence of Urinary Retention

    Time frame: Day 1

    Incidence of participants that do not pass their voiding trial and go home with an indwelling foley

Secondary outcomes

  1. Pain Scale

    Time frame: Day 1: 6-8 hours after surgery

    Pain scale from 0-10. 0-being no pain, 10-being the most pain

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2017
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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