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NCT02727322 · ClinicalTrials.gov registry record · Phase 4
Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
A Phase 4 study of Pelvic Organ Prolapse, sponsored by Halina M Zyczynski, MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 154
- Enrollment target
- 2
- Study locations
NCT02727322: Completed Phase 4 study of Pelvic Organ Prolapse, sponsored by Halina M Zyczynski, MD.
NCT02727322 is a Phase 4 study of Pelvic Organ Prolapse that has completed, run by Halina M Zyczynski, MD. The registered enrollment target is 154 participants, roughly in line with the 141-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02727322, a Phase 4 study of Pelvic Organ Prolapse, has completed, sponsored by Halina M Zyczynski, MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 154 participants
- Enrollment target
- 2
- Study locations
Study Summary
The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo for patients undergoing short term indwelling or clean intermittent self-catheterization (CISC) for acute postoperative urinary retention following pelvic organ prolapse and/or urinary incontinence surgery. Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC or while indwelling catheter is in place. The primary outcome will be symptomatic and culture confirmed UTI within six weeks of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use, and incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women. Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33% to 13%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 154 patients.
Primary Outcome
Frequency of symptomatic, culture-proven UTI; included participants who were empirically treated outside of protocol (symptoms but no culture) within 6 weeks of surgery. Positive culture was defined as at least 100,000 colony forming units (cfu)/ml of uropathic bacteria in a catheterized or midstream clean catch voided urine specimen.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nitrofurantoin
Study Locations (2)
District of Columbia
- Georgetown/MedStar Hospital Center - Washington D.C.
Pennsylvania
- Magee-Womens Hospital of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2016-08 |
| Est. Completion | 2018-05-12 |
| Phase | Phase 4 |
What the finished NCT02727322 record still lists
NCT02727322 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 141-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target.
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02727322 reports a single indexed study location in District of Columbia, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02727322 about?
NCT02727322 is a clinical study titled "Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery". The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo for patients undergoing short term indwelling or clean interm...
What is the current status of trial NCT02727322?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 154 participants. The study started on 2016-08. Estimated completion is 2018-05-12.
What conditions does trial NCT02727322 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse.
What interventions are being tested in trial NCT02727322?
The interventions under investigation include: Placebo (DRUG), Nitrofurantoin (DRUG).
Who is sponsoring clinical trial NCT02727322?
This trial is sponsored by Halina M Zyczynski, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02727322 being conducted?
This trial has 2 study locations across District of Columbia, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02727322's enrollment target sits among peer trials
154 10th of 40 higher than 31 of 40 other Pelvic Organ Prolapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Organ Prolapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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