Urinary Tract Infections
Conditions
Brief summary
The purpose of this study is to measure the concentration of formaldehyde in the urine of women with recurrent urinary tract infections on Hiprex; and then, assuming its urinary presence is confirmed at the proper acid urinary pH, evaluate if such a therapy has favorable effects in decreasing the rate of recurrent urinary tract infections over time.
Interventions
DRUGHiprex
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.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Female 2. Age 50 - 85 3. Have RUTIs (at least 2 UTIs within the past 6 months or 3 within the past year) -
Exclusion criteria
1. Being on antibiotics at baseline (i.e. suppressive therapy or antibiotic therapy for urinary or non-urinary infections) 2. Neurogenic bladder condition 3. Using urinary catheters (including Foley catheter, intermittent catheterization, and suprapubic catheter) 4. Uncontrolled diabetes (HbA1c \> 9) 5. Chronic renal failure defined as serum creatinine \> 1.5 mg/dL 6. History of liver disease 7. Patients from out of town, in whom follow-up will not be possible 8. Pregnancy 9. Allergy to Hiprex 10. Inability to take Hiprex reliably at home, such as having psychosis, dementia, or swallowing disorders 11. Non-English speakers -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Urinary Tract Infections | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Oral Antibiotic Use | 1 year | Total number of calendar days on which a participant received one or more doses of an oral antibiotics |
| Number of Participants That Used Oral Anti-biotic | 1 year | Number of participants who used oral-antibiotics to treat symptomatic UTI episodes during 1 year of Hiprex administration |
| Number of Hospital Re-admissions at 1 Year | 1 year | Number of hospital re-admissions at 1 year due to urosepsis and pyelonephritis. |
| Frequency and Severity of Adverse Events Related to Hiprex | 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 |
| Urine Acidity Levels | 1 year | Urine acidity levels will be measured by urinary pH at each visit. Lower pH will yield a better outcome. |
| Number of Urinary Tract Infection Episodes | up to 1 year | Number of UTI episodes will be measured for this outcome. |
| Severity of UTI Symptoms as Measured by the UTI Symptom Assessment Questionnaire | 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 |
| Duration of Intervals Between UTI Episodes | 1 year | Duration of intervals will be measured between one UTI episode to the next UTI episode |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPhilippe Zimmern, MD
University of Texas Southwestern Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| positive cultures | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
None listed