Nitrofurantoin and Urinary Tract Infections (UTIs)

A Randomized, Double-blind, Placebo-controlled Trial Examining the Effect of Nitrofurantoin Prophylaxis in Women Performing Clean Intermittent Self-catheterization (CISC) After Surgery for Urinary Incontinence and/or Pelvic Organ Prolapse

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00678041

Acronym

APPIC

Enrollment

Registered

2008-05-15

Start date

2008-05-31

Completion date

2009-05-31

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

urinary catheterization, urinary tract infection, urinary incontinence, pelvic floor prolapse, antibiotics

Brief summary

Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects. This study will not require any additional visits or blood draws. You will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a UTI to your doctor.

Detailed description

Abstract: Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (CISC) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo. Study Design: Randomized double-blind placebo-controlled trial. Methods: 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 and for three subsequent days after stopping CISC. Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis. Symptomatic UTI will be defined using strict culture-based definitions. We anticipate that the study will end within 6 weeks of starting CISC. Data Analysis: Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test. Sample Size: Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33% to 10%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 108 patients.

Interventions

DRUGNitrofurantoin

nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

DRUGPlacebo

Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (CISC) prior to discharge from the hospital

Exclusion criteria

* Known drug allergy to nitrofurantoin * A history of renal insufficiency * Renal transplant * Renal nephropathy * A recent history of more than 3 Urinary Tract Infections (UTIs) per year * Known immunocompromised condition (organ transplant, chemotherapy for cancer or arthritis, autoimmune diseases (lupus etc)).

Design outcomes

Primary

Measure	Time frame	Description
Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation	6 to 8 weeks after surgery	Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.

Secondary

Measure	Time frame	Description
Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.	6 weeks after surgery	0 participants analyzed due to study termination.Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Adherence to CISC	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
Patient Perceptions Regarding CISC	6 weeks after surgery	0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.

Countries

United States

Participant flow

Pre-assignment details

This is a double blind 1:1 randomized trial

Participants by arm

Arm	Count
Arm 1: Nitrofurantoin Group extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC	5
Arm 2: Placebo Group identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC	5
Total	10

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Physician Decision	5	5

Baseline characteristics

Characteristic	Arm 1: Nitrofurantoin Group	Arm 2: Placebo Group	Total
Age, Customized at least 18 yrs of age	5 participants	5 participants	10 participants
Sex/Gender, Customized Female	5 participants	5 participants	10 participants
Sex/Gender, Customized Male	0 participants	0 participants	0 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 5	0 / 5
serious Total, serious adverse events	0 / 5	0 / 5

Outcome results

Primary

Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation

Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.

Time frame: 6 to 8 weeks after surgery

Population: 0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.

Secondary

Adherence to CISC

0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.