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Because the study investigator is no longer following these patients as part of this study. They are followed as part of SOC as the study investigator's patients.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Patients with negative and positive urine culture | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hiprex | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Urinary Tract Infections | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Oral Antibiotic Use | Total number of calendar days on which a participant received one or more doses of an oral antibiotics | 1 year |
| Number of Participants That Used Oral Anti-biotic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Zimmern, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT-Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Urinary Tract Infections | 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. | 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) | Posted | Number | UTI events | 1 year | urine culture samples | urine culture samples |
|
one year
No adverse events occurred
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philippe Zimmern, M.D. | University of Texas Southwestern Medical Center | 214-645-8765 | philippe.zimmern@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2022 | Nov 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2022 | Nov 26, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C011481 | methenamine hippurate |
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|
Number of participants who used oral-antibiotics to treat symptomatic UTI episodes during 1 year of Hiprex administration
| 1 year |
| Number of Hospital Re-admissions at 1 Year | Number of hospital re-admissions at 1 year due to urosepsis and pyelonephritis. | 1 year |
| Frequency and Severity of Adverse Events Related to Hiprex | Number of participants who experienced adverse events >= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCA version 5.0 | 1 year |
| Urine Acidity Levels | Urine acidity levels will be measured by urinary pH at each visit. Lower pH will yield a better outcome. | 1 year |
| Number of Urinary Tract Infection Episodes | Number of UTI episodes will be measured for this outcome. | up to 1 year |
| Number of Urinary Tract Infection Episodes | Number of UTI episodes will be measured for this outcome. | up to 2 years |
| Severity of UTI Symptoms as Measured by the UTI Symptom Assessment Questionnaire | 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 | 1 year |
| Duration of Intervals Between UTI Episodes | Duration of intervals will be measured between one UTI episode to the next UTI episode | 1 year |
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| positive cultures | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| urine culture samples |
|
|
| Secondary | Frequency of Oral Antibiotic Use | Total number of calendar days on which a participant received one or more doses of an oral antibiotics | 7 participants used Hiprex which was administered orally | Posted | Mean | Standard Deviation | days | 1 year |
|
|
|
| Secondary | Number of Participants That Used Oral Anti-biotic | Number of participants who used oral-antibiotics to treat symptomatic UTI episodes during 1 year of Hiprex administration | 7 participants used Hiprex which was administered orally | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Number of Hospital Re-admissions at 1 Year | Number of hospital re-admissions at 1 year due to urosepsis and pyelonephritis. | Posted | Number | events | 1 year |
|
|
|
| Secondary | Frequency and Severity of Adverse Events Related to Hiprex | Number of participants who experienced adverse events >= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCA version 5.0 | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Urine Acidity Levels | Urine acidity levels will be measured by urinary pH at each visit. Lower pH will yield a better outcome. | Posted | Mean | 5.0% Confidence Interval | mean urinary pH | 1 year |
|
|
|
| Secondary | Number of Urinary Tract Infection Episodes | Number of UTI episodes will be measured for this outcome. | Posted | Number | UTI episodes | up to 1 year |
|
|
|
| Secondary | Number of Urinary Tract Infection Episodes | Number of UTI episodes will be measured for this outcome. | Posted | Number | UTI episodes | up to 2 years |
|
|
|
| Secondary | Severity of UTI Symptoms as Measured by the UTI Symptom Assessment Questionnaire | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| Secondary | Duration of Intervals Between UTI Episodes | Duration of intervals will be measured between one UTI episode to the next UTI episode | 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. | Posted | 1 year |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |