Trial Outcomes & Findings for Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs (NCT NCT03077711)
NCT ID: NCT03077711
Last Updated: 2020-01-14
Results Overview
Patients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
up to 12 months
Results posted on
2020-01-14
Participant Flow
104 patients actually signed consent to participate but 12 were excluded due to screening failure, decision to decline participation after signing consent, renal failure discovered after enrolling patient, and one unrelated death
Participant milestones
| Measure |
Patients With Recurrent UTIs Arm 1
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent urinary tract infections (UTIs).
|
Patients With Recurrent UTIs Arm 2
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections (UTIs).
Trimethoprim: suppressive antibiotic.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
45
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Patients With Recurrent UTIs Arm 1
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent urinary tract infections (UTIs).
|
Patients With Recurrent UTIs Arm 2
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections (UTIs).
Trimethoprim: suppressive antibiotic.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
noncompliant taking medication
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With Recurrent UTIs Arm 1
n=47 Participants
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
|
Patients With Recurrent UTIs Arm 2
n=45 Participants
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
Trimethoprim: suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 15.4 • n=47 Participants
|
73 years
STANDARD_DEVIATION 10.5 • n=45 Participants
|
72 years
STANDARD_DEVIATION 13 • n=92 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=47 Participants
|
45 Participants
n=45 Participants
|
92 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=47 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
47 Participants
n=47 Participants
|
45 Participants
n=45 Participants
|
92 Participants
n=92 Participants
|
|
BMI
|
30 kg/m2
STANDARD_DEVIATION 6.4 • n=47 Participants
|
30 kg/m2
STANDARD_DEVIATION 7.7 • n=45 Participants
|
30 kg/m2
STANDARD_DEVIATION 6.9 • n=92 Participants
|
|
Parity
|
2.7 number of births
STANDARD_DEVIATION 2.2 • n=47 Participants
|
2.3 number of births
STANDARD_DEVIATION 1.4 • n=45 Participants
|
2.5 number of births
STANDARD_DEVIATION 1.9 • n=92 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsPatients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free.
Outcome measures
| Measure |
Patients With Recurrent UTIs Arm 2
n=43 Participants
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
Trimethoprim: suppressive antibiotic.
|
Patients With Recurrent UTIs Arm 1
n=43 Participants
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs.
|
|---|---|---|
|
Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI
|
119 days
Standard Deviation 94
|
101 days
Standard Deviation 84.4
|
PRIMARY outcome
Timeframe: up to 12 monthsThe number of patient who had a recurrence of UTI within 12 months
Outcome measures
| Measure |
Patients With Recurrent UTIs Arm 2
n=43 Participants
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
Trimethoprim: suppressive antibiotic.
|
Patients With Recurrent UTIs Arm 1
n=43 Participants
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs.
|
|---|---|---|
|
Recurrent UTI
|
28 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsThe number of infections at a 12 month follow up time period as defined by symptoms and positive urine culture.
Outcome measures
| Measure |
Patients With Recurrent UTIs Arm 2
n=43 Participants
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
Trimethoprim: suppressive antibiotic.
|
Patients With Recurrent UTIs Arm 1
n=43 Participants
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs.
|
|---|---|---|
|
Number of Infections
|
1.6 urinary tract infections
Standard Deviation 1.9
|
1.5 urinary tract infections
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: up to 12 monthsThe percentage of patients complaining of adverse effects of each medication, including dyspepsia, dysuria, rash, pruritus, nausea, epigastric pain, vomiting, glossitis, taste changes, fever, and photosensitivity.
Outcome measures
| Measure |
Patients With Recurrent UTIs Arm 2
n=45 Participants
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
Trimethoprim: suppressive antibiotic.
|
Patients With Recurrent UTIs Arm 1
n=47 Participants
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs.
|
|---|---|---|
|
Adverse Effects
diarrhea
|
2 Participants
|
1 Participants
|
|
Adverse Effects
rash
|
0 Participants
|
2 Participants
|
|
Adverse Effects
clostridium difficele infection
|
0 Participants
|
1 Participants
|
|
Adverse Effects
weakness
|
0 Participants
|
2 Participants
|
|
Adverse Effects
abdominal pain
|
1 Participants
|
0 Participants
|
|
Adverse Effects
kidney stone
|
1 Participants
|
0 Participants
|
|
Adverse Effects
no adverse event
|
41 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: We were not able to obtain the Morisky medication survey on all participants.
Morisky Medication Adherence Scale-8 (MMAS-8). Patient tolerability of medications using a tolerability survey. Minimum and maximum scores are 0 and 8 respectively. 0 means no adherence and 8 is maximal adherence. Low adherence corresponds to a score less than 6, medium adherence is between 6 and \<8, and 8 is high adherence.
Outcome measures
| Measure |
Patients With Recurrent UTIs Arm 2
n=21 Participants
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
Trimethoprim: suppressive antibiotic.
|
Patients With Recurrent UTIs Arm 1
n=30 Participants
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs.
|
|---|---|---|
|
Morisky Medication Adherence Survey
|
6.94 units on a scale
Standard Deviation 1.6
|
7.28 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: up to 12 monthsUrine cultures and sensitivities for positive urine cultures
Outcome measures
| Measure |
Patients With Recurrent UTIs Arm 2
n=45 Participants
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
Trimethoprim: suppressive antibiotic.
|
Patients With Recurrent UTIs Arm 1
n=47 Participants
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs.
|
|---|---|---|
|
Bacterial Infection Prevalence and Types
Escherichia coli
|
50 infections
|
43 infections
|
|
Bacterial Infection Prevalence and Types
Klebsiella pneumonia
|
6 infections
|
11 infections
|
|
Bacterial Infection Prevalence and Types
Enterococcus faecalis
|
9 infections
|
3 infections
|
|
Bacterial Infection Prevalence and Types
Extended spectrum beta lactamase Escherichia coli
|
9 infections
|
6 infections
|
|
Bacterial Infection Prevalence and Types
Other bacteria
|
12 infections
|
15 infections
|
|
Bacterial Infection Prevalence and Types
Strains pan sensitive to all antibiotics
|
20 infections
|
5 infections
|
|
Bacterial Infection Prevalence and Types
Strains resistant to trimethoprim
|
30 infections
|
58 infections
|
|
Bacterial Infection Prevalence and Types
Strains resistant to abx other than trimethoprim
|
29 infections
|
10 infections
|
Adverse Events
Patients With Recurrent UTIs Arm 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Patients With Recurrent UTIs Arm 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients With Recurrent UTIs Arm 1
n=47 participants at risk
Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.
Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs.
|
Patients With Recurrent UTIs Arm 2
n=45 participants at risk
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.
Trimethoprim: suppressive antibiotic.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
2.1%
1/47 • Over 1 year from entry into the study
|
4.4%
2/45 • Over 1 year from entry into the study
|
|
Skin and subcutaneous tissue disorders
rash
|
4.3%
2/47 • Over 1 year from entry into the study
|
0.00%
0/45 • Over 1 year from entry into the study
|
|
Gastrointestinal disorders
clostridium difficele colitis
|
2.1%
1/47 • Over 1 year from entry into the study
|
0.00%
0/45 • Over 1 year from entry into the study
|
|
General disorders
weakness
|
4.3%
2/47 • Over 1 year from entry into the study
|
0.00%
0/45 • Over 1 year from entry into the study
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/47 • Over 1 year from entry into the study
|
2.2%
1/45 • Over 1 year from entry into the study
|
|
Renal and urinary disorders
kidney stone
|
0.00%
0/47 • Over 1 year from entry into the study
|
2.2%
1/45 • Over 1 year from entry into the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place