Assessing Pyridium for Post-Sling Urinary Retention

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302936
• Other study ID #: GCO 17-0999
• Status: Completed
• Phase: Phase 4
• Start date: October 24, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Drug:
• Phenazopyridine
to be given preoperatively

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Considered to Have Passed Their Voiding Trial	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.	Day 1
Primary	Incidence of Urinary Retention	Incidence of participants that do not pass their voiding trial and go home with an indwelling foley	Day 1
Secondary	Pain Scale	Pain scale from 0-10. 0-being no pain, 10-being the most pain	Day 1: 6-8 hours after surgery