A Phase 4 interventional study of Nitrofurantoin 100 MG and Placebo Oral Tablet in Catheter-Associated Urinary Tract Infection, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Prevention
The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheterization following pelvic reconstructive surgery and/or urinary incontinence surgery.
Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail their post-operative voiding trial will be included in the study. Upon successfully passing and in-office voiding trial at the time of catheter removal, they will be randomized to either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily for 5 days following catheter removal. The primary outcome will be the treatment of clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use and medication compliance.
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 32% to 14%, with 80% power, and a two-sided alpha of 0.05, we should recruit a total of 164 patients.
Urinary tract infections (UTI) are the most common hospital-acquired infections, accounting for nearly 30% of cases of nosocomial infections and affecting nearly 1 million people per year.
Following pelvic reconstructive and urinary incontinence surgery, UTIs are one of the most common complications with a risk between 8.9%-34%. The baseline risk of UTI associated with pelvic floor surgery ranges between 5-35%, increasing greatly with catheterization.
Postoperative voiding dysfunction and incomplete bladder emptying is common following pelvic reconstructive and incontinence surgeries, with incidence ranging from 2.5 % to 31%. As a result, these women may have additional catheterization for a short period of time, which increases the risk of UTI. There is a 15-20% risk of developing a postoperative UTI with short-term catheterization, even if the catheter remains in place for merely 24 hours. The risk of UTI increases 5-10% each day the catheter is left in place.
Numerous studies have been conducted to evaluate different prophylactic antibiotic regimens to help decrease the rate of postoperative catheter-associated UTIs. Many of these studies have shown precedent for the use of antibiotic prophylaxis.
Nitrofurantoin has been evaluated as a prophylactic regimen for use during short-term catheterization. These studies had favorable results, decreasing the incidence of UTI postoperatively.
Although there are a few studies showing favorable results for the use of prophylactic nitrofurantoin during catheterization after pelvic surgery, the optimal timing of antibiotic administration and length of dosing regimen is not well defined. The American Urological Association (AUA) recommends empiric antibiotic treatment at the time of external urinary catheter removal in patients with risk factors, such as tobacco use, advanced age, and anatomic abnormalities of the urinary tract. The AUA Panel does cite that bacteriuria in the setting of noninfectious urinary tract disease is a risk factor for bacteremia, and, thus, prophylactic antibiotic treatment at time the of catheter removal may be indicated. The AUA does recommend empiric antibiotic treatment at the removal of an external urinary catheter in patients with risk factors. However, there is no standardization concerning the type of antibiotic to be used or treatment duration.
Although there are a few studies showing favorable results for use of nitrofurantoin during catheterization after pelvic surgery, there are no clearly defined recommendations regarding its use for urinary tract infection prevention after catheter removal. Therefore, the objective of our study is to examine the effects of administration of nitrofurantoin therapy at the time of Foley catheter removal for the prevention of catheter-associated UTI in patients undergoing POP and/or urinary incontinence surgery.
Primary Objective:
To evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheterization following pelvic reconstructive surgery. The primary outcome will be the treatment of clinically suspected and/or culture-proven UTI within 30 days of surgery.
Secondary Objective:
To evaluate adverse outcomes related to study medications in each group and to evaluate medication compliance
Null Hypothesis:
The null hypothesis is that the administration of nitrofurantoin will not reduce the rate of UTI compared with placebo.
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This study's enrollment of 164 is above the median of 70 across 65 interventional studies indexed under Prolapse.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal
Drug: Nitrofurantoin 100 MG
Receives twice daily matching placebo for 5 days following catheter removal
Drug: Placebo Oral Tablet
Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
Matching placebo
UTI
Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery
Time frame: within 30 days of surgery
Adverse Events
Number of participants with an adverse event only related to study drug administration
Time frame: within 30 days of surgery
Medication Compliance
Compliance assessed by use of a medication diary during treatment period
Time frame: within 30 days of surgery
Consecutive women were prescreened for eligibility and introduced to the study prior to surgery. Women with postoperative urinary retention following pelvic organ prolapse and/or incontinence surgery were approached for study inclusion at the time of their postoperative in-office voiding trial between September 2017 and April 2019.
| Milestone | Nitrofurantoin | Placebo |
|---|---|---|
| Started | 82 | 82 |
| Completed | 82 | 76 |
| Not completed | 0 | 6 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery
| Participants | Nitrofurantoin | Placebo |
|---|---|---|
| UTI | 15 | 14 |
Number of participants with an adverse event only related to study drug administration
| Participants | Nitrofurantoin | Placebo |
|---|---|---|
| Allergy | 0 | 0 |
| Nausea | 5 | 2 |
| Vomiting | 0 | 0 |
| Diarrhea | 0 | 0 |
| Other | 0 | 2 |
Compliance assessed by use of a medication diary during treatment period
| ratio | Nitrofurantoin | Placebo |
|---|---|---|
| Medication Compliance | 0.95 ± 0.18 | 0.96 ± 0.15 |
Collected over 30 days (from surgery until 30 days postop). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nitrofurantoin | 0/82 (0%) | 0/82 (0%) | 5/82 (6.1%) |
| Placebo | 0/82 (0%) | 0/82 (0%) | 4/82 (4.9%) |
| Event | Nitrofurantoin | Placebo |
|---|---|---|
| Medication IntoleranceGastrointestinal disorders | 5/82 | 2/82 |
| Medication IntoleranceMusculoskeletal and connective tissue disorders | 0/82 | 1/82 |
| Medication IntoleranceGeneral disorders | 0/82 | 1/82 |
Analyses were conducted on Intention-to-Treat Principle
| Age, Continuous(years) | Nitrofurantoin | Placebo | Total |
|---|---|---|---|
| Mean | 61.6 ± 11.7 | 61.1 ± 12.4 | 61.4 ± 12.0 |
| Sex/Gender, Customized(Participants) | Nitrofurantoin | Placebo | Total |
|---|---|---|---|
| Female | 82 | 82 | 164 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Nitrofurantoin | Placebo | Total |
|---|---|---|---|
| Caucasian | 79 | 72 | 151 |
| Black | 1 | 8 | 9 |
| Other | 2 | 2 | 4 |
| Body Mass Index (BMI), kg/m^2(kg/m^2) | Nitrofurantoin | Placebo | Total |
|---|---|---|---|
| Mean | 27.1 ± 4.7 | 28.6 ± 5 | 27.8 ± 4.9 |
| Parity(Parity) | Nitrofurantoin | Placebo | Total |
|---|---|---|---|
| Median | 2 (1 to 3) | 2 (2 to 3) | 2 (2 to 3) |
| POP-Q Stage(units on a scale) | Nitrofurantoin | Placebo | Total |
|---|---|---|---|
| Median | 2 (2 to 3) | 2 (2 to 3) | 2 (2 to 3) |
| Menopausal Status(Participants) | Nitrofurantoin | Placebo | Total |
|---|---|---|---|
| Premenopausal | 18 | 17 | 35 |
| Postmenopausal | 64 | 64 | 128 |
| Missing data | 0 | 1 | 1 |
| Postmenopausal Hormone Use(Participants) | Nitrofurantoin | Placebo | Total |
|---|---|---|---|
| No Hormone Therapy | 58 | 58 | 116 |
| Vaginal Estrogen Therapy | 20 | 19 | 39 |
| Systemic Hormonal Therapy | 4 | 5 | 9 |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Nitrofurantoin
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