Assessing Pyridium for Post-Sling Urinary Retention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03302936
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : October 17, 2018
Information provided by (Responsible Party):
Annacecilia Peacher-Seaney, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Urinary Retention Drug: Phenazopyridine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pyridium arm
Phenazopyridine 200mg tablet, once prior to surgery
Drug: Phenazopyridine
to be given preoperatively
Other Name: Pyridium

No Intervention: Control arm
No intervention in this group. Routine perioperative care.

Primary Outcome Measures :
  1. Voiding trail [ 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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03302936

Contact: Annacecilia Peacher-Seaney, M.D. 210-488-7216
Contact: Charles Ascher-Walsh, M.D. 212-241-7090

United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Joyce Preisinger    212-241-7090   
Principal Investigator: Charles Ascher-Walsh, M.D.         
Sub-Investigator: Annacecilia Peacher-Seaney, M.D.         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Charles Ascher-Walsh, M.D. Icahn School of Medicine at Mount Sinai

Responsible Party: Annacecilia Peacher-Seaney, Principal Investigator, Female Pelvic Medicine and Reconstructive Surgery Fellow, Icahn School of Medicine at Mount Sinai Identifier: NCT03302936     History of Changes
Other Study ID Numbers: GCO 17-0999
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Annacecilia Peacher-Seaney, Icahn School of Medicine at Mount Sinai:
Midurethral sling

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases