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Assessing Pyridium for Post-Sling Urinary Retention

Primary Purpose

Urinary Retention

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Phenazopyridine
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention focused on measuring Midurethral sling, Pyridium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pyridium arm

Control arm

Arm Description

Phenazopyridine 200mg tablet, once prior to surgery

No intervention in this group. Routine perioperative care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2017
Last Updated
October 9, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03302936
Brief Title
Assessing Pyridium for Post-Sling Urinary Retention
Official Title
A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
Midurethral sling, Pyridium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pyridium arm
Arm Type
Experimental
Arm Description
Phenazopyridine 200mg tablet, once prior to surgery
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No intervention in this group. Routine perioperative care.
Intervention Type
Drug
Intervention Name(s)
Phenazopyridine
Other Intervention Name(s)
Pyridium
Intervention Description
to be given preoperatively
Primary Outcome Measure Information:
Title
Number of Participants Considered to Have Passed Their Voiding Trial
Description
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
Title
Incidence of Urinary Retention
Description
Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Pain Scale
Description
Pain scale from 0-10. 0-being no pain, 10-being the most pain
Time Frame
Day 1: 6-8 hours after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Ascher-Walsh, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessing Pyridium for Post-Sling Urinary Retention

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