Phase 4
N=98
Assessing Pyridium for Post-Sling Urinary Retention
Urinary Retention
Bottom Line
View on ClinicalTrials.gov: NCT03302936 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants Considered to Have Passed Their Voiding Trial — 30; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Phenazopyridine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Considered to Have Passed Their Voiding Trial |
30; 30 | — |
| PRIMARY Incidence of Urinary Retention |
16; 15 | — |
| SECONDARY Pain Scale |
3; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03302936). 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.