Phase 3 N=152 Randomized Treatment

Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

Urinary Retention Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT03065075 ↗

Enrolled (actual)

152

Serious AEs

0.7%

Results posted

Mar 2019

Primary outcome: Primary: Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) — 30; 25 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Phenazopyridine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Massachusetts, Worcester
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT)	30; 25	—

Summary

To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery.

Eligibility Criteria

Inclusion Criteria

Women undergoing overnight admission after prolapse surgery

Exclusion Criteria

Unable to provide consent
Under 18 years of age
Pregnant women
Prisoners
Using intermittent self-catheterization preoperatively
Neurological disease or spinal cord injury resulting in voiding dysfunction
Undergoing spinal or epidural anesthesia for the procedure
Allergy to phenazopyridine
Renal insufficiency
Liver disease
Intra-operative bladder injury necessitating use of prolonged indwelling Foley catheter

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03065075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.