Assessing Pyridium for Post-Sling Urinary Retention

NCT03302936 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GCO 17-0999
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Keywords

Midurethral sling; Pyridium

Outcome Measures

Primary Outcomes (2)

• 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

• Incidence of Urinary Retention

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

  Day 1

Secondary Outcomes (1)

• Pain Scale

  Day 1: 6-8 hours after surgery

Study Arms (2)

Pyridium arm

EXPERIMENTAL

Phenazopyridine 200mg tablet, once prior to surgery

Drug: Phenazopyridine

Control arm

NO INTERVENTION

No intervention in this group. Routine perioperative care.

Interventions

Phenazopyridine DRUG

to be given preoperatively

Also known as: Pyridium

Pyridium arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

Phenazopyridine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Annacecilia Peacher-Holderied
• Organization: Icahn School of Medicine at Mount Sinai

apeacher4@gmail.com

2104887216

Study Officials

• Charles Ascher-Walsh, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 5, 2017
• Study Start: October 24, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 29, 2019
• Results First Posted: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)