Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections.
Purpose
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.
Condition
- Urinary Tract Infections
Eligibility
- Eligible Ages
- Between 50 Years and 85 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 -
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1 - Patients with negative and positive urine culture |
|
Recruiting Locations
More Details
- NCT ID
- NCT04709601
- Status
- Terminated
- Sponsor
- University of Texas Southwestern Medical Center