Trial Outcomes & Findings for Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections. (NCT NCT04709601)

Results Overview

It would be measured by counting the positive urine cultures, or UTI-like episodes requiring antibiotic treatment during the 1 year of the study period.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

1 year

Results posted on

2026-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 - Patients With Negative and Positive Urine Culture Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Overall Study STARTED	14
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 - Patients With Negative and Positive Urine Culture Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Overall Study Lack of Efficacy	2
Overall Study side effects	2
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=14 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Age, Continuous	71.4 years n=58 Participants
Sex: Female, Male Female	14 Participants n=58 Participants
Sex: Female, Male Male	0 Participants n=58 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=58 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=58 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=58 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=58 Participants
Race (NIH/OMB) Asian	0 Participants n=58 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=58 Participants
Race (NIH/OMB) Black or African American	0 Participants n=58 Participants
Race (NIH/OMB) White	14 Participants n=58 Participants
Race (NIH/OMB) More than one race	0 Participants n=58 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=58 Participants
Region of Enrollment United States	14 Participants n=58 Participants
positive cultures	0 Participants n=58 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Data was not collected for this outcome from the seven participants that did not complete the study. This was due to participant withdrawal (n=2), Covid (n=2), recurring urinary tract infection (n=2), and Lost to Follow-up (n=1)

It would be measured by counting the positive urine cultures, or UTI-like episodes requiring antibiotic treatment during the 1 year of the study period.

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 urine culture samples Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Number of Urinary Tract Infections	0 UTI events

SECONDARY outcome

Timeframe: 1 year

Population: 7 participants used Hiprex which was administered orally

Total number of calendar days on which a participant received one or more doses of an oral antibiotics

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Frequency of Oral Antibiotic Use	0.0 days Standard Deviation 0.0

SECONDARY outcome

Timeframe: 1 year

Population: 7 participants used Hiprex which was administered orally

Number of participants who used oral-antibiotics to treat symptomatic UTI episodes during 1 year of Hiprex administration

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Number of Participants That Used Oral Anti-biotic	0 Participants

SECONDARY outcome

Timeframe: 1 year

Number of hospital re-admissions at 1 year due to urosepsis and pyelonephritis.

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Number of Hospital Re-admissions at 1 Year	0 events

SECONDARY outcome

Timeframe: 1 year

Number of participants who experienced adverse events \>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCA version 5.0

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Frequency and Severity of Adverse Events Related to Hiprex	0 Participants

SECONDARY outcome

Timeframe: 1 year

Urine acidity levels will be measured by urinary pH at each visit. Lower pH will yield a better outcome.

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Urine Acidity Levels	6 mean urinary pH Interval 5.5 to 6.5

SECONDARY outcome

Timeframe: up to 1 year

Number of UTI episodes will be measured for this outcome.

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Number of Urinary Tract Infection Episodes	0 UTI episodes

SECONDARY outcome

Timeframe: up to 2 years

Number of UTI episodes will be measured for this outcome.

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Number of Urinary Tract Infection Episodes	2 UTI episodes

SECONDARY outcome

Timeframe: 1 year

UTI Symptom Assessment questionnaire measures severity of UTI symptoms. Possible score range from 0 to 3 (0= Did not have 1= Mild 2=Moderate, and 3=Severe), higher score indicates higher severity of UTI symptoms

Outcome measures

Outcome measures
Measure	Group 1 - Patients With Negative and Positive Urine Culture n=7 Participants Hiprex: Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Severity of UTI Symptoms as Measured by the UTI Symptom Assessment Questionnaire	0.0 score on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: 1 year

Population: Out of 7 subjects, no subject had any UTI episode at 1 year and since 2 or more episodes are needed to calculate "duration of interval", this outcome couldn't be analyzed at 1 year.

Duration of intervals will be measured between one UTI episode to the next UTI episode

Outcome measures

Outcome data not reported

Adverse Events

Group 1 - Patients With Negative and Positive Urine Culture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Philippe Zimmern, M.D.

University of Texas Southwestern Medical Center

Phone: 214-645-8765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place