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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK140224-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Texas | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this clinical trial is to learn if the drug Nitrofurantoin (NF) taken as a daily antibiotic, works to treat cystitis compared to electrofulguration (EF) and Nitrofurantoin (NF) daily antibiotic.
This is a study for women age 18 -85 with a well-documented history of rUTI (recurrent urinary tract infection) for at least one year. This randomized multicentric clinical trial will determine the efficacy of conventional 6 months Nitrofurantoin (NF) daily antibiotic prophylaxis alone versus electrofulguration (EF) associated with a 6 months NF daily antibiotic prophylactic course for early stages of chronic cystitis (stages 1 and 2) as determined on office cystoscopy.
This study will ask the participant (n=104) to return to the Urology clinic at UT Southwestern Medical Center (n=52) or The University of Kansas Medical Center (n=52) for a total of 8 compensated visits throughout 30 months after the start of this randomized trial to make sure that the treatment worked well for them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrofurantoin (NF) daily antibiotic prophylaxis | Active Comparator | Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months. |
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| Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrofulguration (EF) | Procedure | Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of cystitis with NF vs EF+NF | Rate of culture documented symptomatic UTIs following the completion of each 6-month study arm intervention. Specifically, from 6 to 18 months (first year) after the completion of the original intervention and, 18 to 30 months (second year). | Baseline to 30 months after enrollment to completion of study |
| Measure | Description | Time Frame |
|---|---|---|
| No recurring cystitis | Comparison of patient characteristics between the two enrolling institutions. | Baseline to 30 months after enrollment to completion of study |
| Rate comparison of culture-documented breakthrough |
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Inclusion Criteria:
Exclusion Criteria:
Biologically born female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meghan Leak | Contact | 214-645-8787 | utswuti@utsouthwestern.edu | |
| Philippe Zimmern, M.D. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Zimmern, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas | Not yet recruiting | Kansas City | Kansas | 66160 | United States |
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|
| Nitrofurantoin (NF) | Drug | Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months. |
|
Rate of culture-documented breakthrough UTIs between the two treatment arms.
| Baseline to 30 months after enrollment to completion of study |
| Rate of multi-drug resistant organisms | Rate of urine cultures showing multi-drug resistant organisms in each treatment arm. | Baseline to 30 months after enrollment to completion of study |
| Rate of non-urine culture | Rate of non-urine culture documented symptomatic UTI episodes for 12 months and 24 months following end of treatment arms, as determined by the Urinary Tract Infection Symptom Assessment (UTISA) (a total score of 3 or higher, or any individual score of 2 or 3) between the two treatment arms. | Baseline to 30 months after enrollment to completion of study |
| Rate of behavior changes | Rate of behavior changes in both groups (fluid increases or use of non-antibiotic therapies, e.g., cranberry, D-mannose, urinary analgesics, hormonal therapy) in each treatment arm. | Baseline to 30 months after enrollment to completion of study |
| Rate of score differences in symptoms and quality of life | Rate of score differences in patient symptoms and quality of life assessments using validated questionnaires- the Urinary Tract Infection Symptom Assessment (UTISA), Urinary Distress Inventory, Short Form (UDI-6), and Quality of Life scale (QoL) by Visual Analogue Scale (VAS) between both treatment arms. | Baseline to 30 months after enrollment to completion of study |
| Rate of UTI episodes | Rate of UTI episodes (after first and second year of the completion of the intervention) compared to the rate of UTI episodes prior to the start of study | Baseline to 30 months after enrollment to completion of study |
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| D009582 | Nitrofurantoin |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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