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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 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.

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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.

Conditions Studied

Pelvic Organ Prolapse

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

FieldValue
Enrollment Target 154 participants
Start Date 2016-08
Est. Completion 2018-05-12
Phase Phase 4

Sponsor

Halina M Zyczynski, MD

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02727322

The ClinicalTrials.gov registry entry for NCT02727322 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 141-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target. The listed sponsor is Halina M Zyczynski, MD, which has 3 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.