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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Nitrofurantoin
Receives once daily nitrofurantoin 100mg
Patients will receive nitrofurantoin 100mg once daily or a placebo. Pills will be identical.
Other Name: Macrobid
Placebo Comparator: Placebo
Receives matching placebo
- 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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Erin S Lavelle, MD||University of Pittsburgh|