Phase 4
Completed N=98
Assessing Pyridium for Post-Sling Urinary Retention
Urinary Retention
Source: ClinicalTrials.gov NCT03302936 ↗
Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants Considered to Have Passed Their Voiding Trial — 30; 30 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.