Trial Outcomes & Findings for Short-course Methenamine Hippurate for Prevention of Post-operative UTI (NCT NCT02358993)

Results Overview

This is defined as any symptomatic UTI requiring treatment with antibiotics as determined by the development of 2 or more of the following symptoms, in the absence of vaginal symptoms: urinary frequency; urinary urgency; dysuria; fever over 38oC/100.4oF; suprapubic, flank, or back pain; and/or chills.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

201 participants

Primary outcome timeframe

3 weeks post-operative

Results posted on

2022-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Methenamine Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. methenamine hippurate: A urinary antiseptic used for prevention of UTI	Ciprofloxacin Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
Overall Study STARTED	105	96
Overall Study COMPLETED	103	94
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methenamine n=103 Participants Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. methenamine hippurate: A urinary antiseptic used for prevention of UTI	Ciprofloxacin n=94 Participants Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI	Total n=197 Participants Total of all reporting groups
Race/Ethnicity, Customized Caucasion	83 Participants n=101 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.	72 Participants n=93 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.	155 Participants n=194 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.
Race/Ethnicity, Customized Black	15 Participants n=101 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.	18 Participants n=93 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.	33 Participants n=194 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.
Age, Continuous	63.9 years STANDARD_DEVIATION 10.7 • n=103 Participants • In the Ciprofloxacin group, one age datapoint was missing from the dataset.	61.6 years STANDARD_DEVIATION 10.5 • n=93 Participants • In the Ciprofloxacin group, one age datapoint was missing from the dataset.	62.8 years STANDARD_DEVIATION 10.6 • n=196 Participants • In the Ciprofloxacin group, one age datapoint was missing from the dataset.
Sex: Female, Male Female	103 Participants n=103 Participants	94 Participants n=94 Participants	197 Participants n=197 Participants
Sex: Female, Male Male	0 Participants n=103 Participants	0 Participants n=94 Participants	0 Participants n=197 Participants
Race/Ethnicity, Customized Asian American/Pacific Islander	2 Participants n=101 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.	1 Participants n=93 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.	3 Participants n=194 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.
Race/Ethnicity, Customized Did not answer	1 Participants n=101 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.	2 Participants n=93 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.	3 Participants n=194 Participants • Missing race data on 1 participant randomized to the Ciprofloxin arm and 2 participants randomized to the methenamine hippurate arm.
BMI	27.1 kg/m^2 STANDARD_DEVIATION 4.9 • n=103 Participants	28 kg/m^2 STANDARD_DEVIATION 5.3 • n=94 Participants	27.6 kg/m^2 STANDARD_DEVIATION 5.1 • n=197 Participants
Postmenopausal	83 Participants n=103 Participants	71 Participants n=94 Participants	154 Participants n=197 Participants
Current Smoker	3 Participants n=103 Participants	5 Participants n=94 Participants	8 Participants n=197 Participants
History of recurrent UTI	4 Participants n=103 Participants	4 Participants n=94 Participants	8 Participants n=197 Participants
Recent preoperative UTI	4 Participants n=103 Participants	2 Participants n=94 Participants	6 Participants n=197 Participants

PRIMARY outcome

Timeframe: 3 weeks post-operative

Population: Intent to Treat model

This is defined as any symptomatic UTI requiring treatment with antibiotics as determined by the development of 2 or more of the following symptoms, in the absence of vaginal symptoms: urinary frequency; urinary urgency; dysuria; fever over 38oC/100.4oF; suprapubic, flank, or back pain; and/or chills.

Outcome measures

Outcome measures
Measure	Methenamine n=101 Participants Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. methenamine hippurate: A urinary antiseptic used for prevention of UTI	Ciprofloxacin n=93 Participants Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
Treatment of Clinically Suspected UTI - Using Intent to Treat Analysis	13 Participants	12 Participants

PRIMARY outcome

Timeframe: 3 weeks post-operative

Population: Per protocol model

This is defined as any symptomatic UTI requiring treatment with antibiotics as determined by the development of 2 or more of the following symptoms, in the absence of vaginal symptoms: urinary frequency; urinary urgency; dysuria; fever over 38oC/100.4oF; suprapubic, flank, or back pain; and/or chills.

Outcome measures

Outcome measures
Measure	Methenamine n=98 Participants Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. methenamine hippurate: A urinary antiseptic used for prevention of UTI	Ciprofloxacin n=89 Participants Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
Treatment of Clinically Suspected UTI - Per Protocol	12 Participants	12 Participants

SECONDARY outcome

Timeframe: 3 weeks post-operative

All patients will be encouraged to submit urine cultures prior to treatment, but this is not always possible. Amongst patients who undergo urine culture as part of standard of care for UTI, the rate of positive cultures will be identified.

Outcome measures

Outcome measures
Measure	Methenamine n=101 Participants Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. methenamine hippurate: A urinary antiseptic used for prevention of UTI	Ciprofloxacin n=93 Participants Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
Number of Participants With Culture-positive Symptomatic UTI	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 weeks post-operative

All patients who submit urine cultures that are positive will have sensitivities performed as per standard care. The prevalence of bacterial species and sensitivities will be collected

Outcome measures

Outcome measures
Measure	Methenamine n=101 Participants Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. methenamine hippurate: A urinary antiseptic used for prevention of UTI	Ciprofloxacin n=93 Participants Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
Antibiotic Resistance of Culture-positive Symptomatic UTI	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 weeks post-operative

Population: The data for this secondary was not collected. No costs were captured.

Routine costs of prevention of UTI with methenamine hippurate prophylaxis will be compared with costs of prevention of UTI with fluoroquinolone prophylaxis. We plan to capture costs for each direct medical service use, direct non-medical items, and indirect items related to post-operative UTIs in each arm of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 24 hours of administration

Population: The data for this secondary outcome measure was not collected.

Adverse effects from the administration of methenamine and fluoroquinolones will be collected.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks post-operative

We plan to analyze the prevalence of UTI in this population that meet the definitions of symptomatic UTI and catheter-associated UTI according to the National Healthcare Safety Network criteria.

Outcome measures

Outcome measures
Measure	Methenamine n=101 Participants Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. methenamine hippurate: A urinary antiseptic used for prevention of UTI	Ciprofloxacin n=93 Participants Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
Rate of UTI Consistent With NHSN Criteria	10 Participants	6 Participants

Adverse Events

Methenamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ciprofloxacin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Methenamine n=103 participants at risk Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. methenamine hippurate: A urinary antiseptic used for prevention of UTI	Ciprofloxacin n=94 participants at risk Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal. Ciprofloxacin: An antibiotic used for treatment and prevention of UTI
Gastrointestinal disorders nausea	0.00% 0/103 • The AEs were collected from time of surgery to their clinical post-operative visit, usually between 4 and 12 weeks post-op.	2.1% 2/94 • Number of events 2 • The AEs were collected from time of surgery to their clinical post-operative visit, usually between 4 and 12 weeks post-op.
Musculoskeletal and connective tissue disorders muscle pain	0.00% 0/103 • The AEs were collected from time of surgery to their clinical post-operative visit, usually between 4 and 12 weeks post-op.	1.1% 1/94 • Number of events 1 • The AEs were collected from time of surgery to their clinical post-operative visit, usually between 4 and 12 weeks post-op.

Additional Information

Dr Uduak Andy

University of Pennsylvania

Phone: 215-662-7709

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place