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Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery

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ClinicalTrials.gov Identifier: NCT02727322
Recruitment Status : Completed
First Posted : April 4, 2016
Results First Posted : May 20, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Halina M Zyczynski, MD, University of Pittsburgh

Brief 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.


Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Drug: Nitrofurantoin Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Nitrofurantoin Prophylaxis During Catheterization for Acute Postoperative Urinary Retention After Pelvic Reconstructive Surgery
Study Start Date : August 2016
Actual Primary Completion Date : March 27, 2018
Actual Study Completion Date : May 12, 2018


Arm Intervention/treatment
Active Comparator: Nitrofurantoin
Receives once daily nitrofurantoin 100mg
Drug: Nitrofurantoin
Patients will receive nitrofurantoin 100mg once daily or a placebo. Pills will be identical.
Other Name: Macrobid

Placebo Comparator: Placebo
Receives matching placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Number of Participants Experiencing Urinary Tract Infection Within 6 Weeks of Surgery [ Time Frame: within 6 weeks of surgery ]

    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.



Secondary Outcome Measures :
  1. Number of Participants Who Experienced at Least One Adverse Event Symptom While Requiring Catheterization [ Time Frame: within 6 weeks of surgery ]
    This is the number of participants who experienced at least one adverse symptom as reported on the diary completed daily while requiring catheterization. These adverse symptoms included: constipation, nausea/vomiting, drowsiness, headache, flatulence, abdominal pain, dizziness, diarrhea, rash/itching, dyspepsia, fever/chills, amblyopia and other.

  2. Frequency of Urine Cultures Positive for Nitrofurantoin-resistant Isolates [ Time Frame: within 6 weeks of surgery ]
    Frequency of urine cultures with one or more organisms resistant to nitrofurantoin. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Women who have undergone surgery for the correction of pelvic organ prolapse and/or urinary incontinence and failed a postoperative voiding trial

Exclusion Criteria:

  • Known drug allergy to nitrofurantoin
  • History of renal insufficiency
  • Renal transplant
  • Renal nephropathy
  • Recent history of more than 3 UTIs per year
  • History of nitrofurantoin-induced pulmonary injury or nitrofurantoin associated cholestatic jaundice/hepatic dysfunction
  • Known immunocompromised condition (organ transplant, chemotherapy, immune suppression associated with autoimmune disease).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727322


Locations
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United States, District of Columbia
Georgetown/MedStar Hospital Center
Washington, District of Columbia, United States, 20007
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Halina M Zyczynski, MD
Investigators
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Principal Investigator: Erin S Lavelle, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Halina M Zyczynski, MD, University of Pittsburgh:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Halina M Zyczynski, MD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02727322     History of Changes
Other Study ID Numbers: PRO15110557
First Posted: April 4, 2016    Key Record Dates
Results First Posted: May 20, 2019
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make participant data available
Additional relevant MeSH terms:
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Urinary Retention
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents