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Several methods are available for use in the prevention of recurrent urinary tract infections (UTIs) over the past few decades. These methods include suppressive antibiotics, estrogen cream, methenamine hippurate, d-mannose, cranberry, probiotics, and vitamin C. Of these, the majority of the literature is in favor of use of suppressive antibiotics for preventing UTIs. However, this data is now about 10 years old. Increasing use of antibiotics over the years has lead to increased resistance of bacteria. In addition, long-term antibiotic use has several adverse effects, some life-threatening. There is recent literature evaluating the use of several of the alternatives to suppressive antibiotics with mixed results. A comparative study of the efficacy of methenamine hippurate to suppressive antibiotics is lacking in the current literature. Several early partly-randomized trials done with methenamine hippurate have shown promising results, but are only as recent as 1987. The primary objective of this prospective, randomized study is to determine whether there is a significant difference in the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive antibiotics. The secondary objective of this study is to determine how well patients are able to tolerate each of these medications and what adverse effects are observed in a given 1 year time period. The long-term goals of this study are to find an alternative to using suppressive antibiotics, potentially with a lower adverse effect profile and less of the dangers of long term antibiotic use. Finding an alternative to suppressive antibiotics would also tackle the issue of antibiotic resistance.
Hypothesis:
The hypothesis of this study is that the group taking trimethoprim will have a lower recurrence rate than those taking methenamine hippurate based on the literature. The investigators aim to identify to what degree that difference is and whether or not it is an acceptable difference given the greater degree of an antibiotic resistance.
Objectives:
The primary objective of this prospective, randomized study is to determine whether there is a significant difference in the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive antibiotics independent of vaginal estrogen use.
The secondary objective of this study is to determine how well patients are able to tolerate each of these medications and what adverse effects are observed in a 1 year time period.
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with recurrent UTIs arm 1 | Active Comparator | Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections. |
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| Patients with recurrent UTIs arm 2 | Active Comparator | Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimethoprim | Drug | suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI | Patients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free. | up to 12 months |
| Recurrent UTI | The number of patient who had a recurrence of UTI within 12 months | up to 12 months |
| Number of Infections | The number of infections at a 12 month follow up time period as defined by symptoms and positive urine culture. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects | The percentage of patients complaining of adverse effects of each medication, including dyspepsia, dysuria, rash, pruritus, nausea, epigastric pain, vomiting, glossitis, taste changes, fever, and photosensitivity. | up to 12 months |
| Morisky Medication Adherence Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore Univeristy HealthSystem | Skokie | Illinois | 60076 | United States |
The investigators are currently only recruiting at one institution and only researchers on the original institutional review board will have access to data. Only the principal investigator and research coordinator will have the data to be analyzed.
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104 patients actually signed consent to participate but 12 were excluded due to screening failure, decision to decline participation after signing consent, renal failure discovered after enrolling patient, and one unrelated death
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Recurrent UTIs Arm 1 | Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections. Methenamine hippurate: antiseptic used in the prevention of recurrent urinary tract infections (UTIs). |
| FG001 | Patients With Recurrent UTIs Arm 2 | Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections (UTIs). Trimethoprim: suppressive antibiotic. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Recurrent UTIs Arm 1 | Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections. Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI | Patients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free. | Posted | Mean | Standard Deviation | days | up to 12 months |
|
Over 1 year from entry into the study
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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 | Patients With Recurrent UTIs Arm 1 | Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections. Methenamine hippurate: antiseptic used in the prevention of recurrent UTIs. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Botros, DO | Lehigh Valley Health Network | 4845917480 | carolyn.botros@lvhn.org |
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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 | Feb 8, 2016 | Jan 4, 2020 | Prot_SAP_000.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 |
|---|---|
| D014295 | Trimethoprim |
| C011481 | methenamine hippurate |
| ID | Term |
|---|---|
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Patients diagnosed with recurrent urinary tract infections are recruited into this study.
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|
| Methenamine hippurate | Drug | antiseptic used in the prevention of recurrent UTIs. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study). |
|
|
Morisky Medication Adherence Scale-8 (MMAS-8). Patient tolerability of medications using a tolerability survey. Minimum and maximum scores are 0 and 8 respectively. 0 means no adherence and 8 is maximal adherence. Low adherence corresponds to a score less than 6, medium adherence is between 6 and <8, and 8 is high adherence. |
| up to 12 months |
| Bacterial Infection Prevalence and Types | Urine cultures and sensitivities for positive urine cultures | up to 12 months |
| BG001 |
| Patients With Recurrent UTIs Arm 2 |
Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections. Trimethoprim: suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
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| Parity | Mean | Standard Deviation | number of births |
|
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| Primary | Recurrent UTI | The number of patient who had a recurrence of UTI within 12 months | Posted | Count of Participants | Participants | up to 12 months |
|
|
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| Primary | Number of Infections | The number of infections at a 12 month follow up time period as defined by symptoms and positive urine culture. | Posted | Mean | Standard Deviation | urinary tract infections | up to 12 months |
|
|
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| Secondary | Adverse Effects | The percentage of patients complaining of adverse effects of each medication, including dyspepsia, dysuria, rash, pruritus, nausea, epigastric pain, vomiting, glossitis, taste changes, fever, and photosensitivity. | Posted | Count of Participants | Participants | up to 12 months |
|
|
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| Secondary | Morisky Medication Adherence Survey | Morisky Medication Adherence Scale-8 (MMAS-8). Patient tolerability of medications using a tolerability survey. Minimum and maximum scores are 0 and 8 respectively. 0 means no adherence and 8 is maximal adherence. Low adherence corresponds to a score less than 6, medium adherence is between 6 and <8, and 8 is high adherence. | We were not able to obtain the Morisky medication survey on all participants. | Posted | Mean | Standard Deviation | units on a scale | up to 12 months |
|
|
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| Secondary | Bacterial Infection Prevalence and Types | Urine cultures and sensitivities for positive urine cultures | Posted | Number | infections | up to 12 months |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 6 |
| 47 |
| EG001 | Patients With Recurrent UTIs Arm 2 | Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections. Trimethoprim: suppressive antibiotic. | 0 | 45 | 0 | 45 | 4 | 45 |
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| clostridium difficele colitis | Gastrointestinal disorders | Non-systematic Assessment |
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| weakness | General disorders | Non-systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| kidney stone | Renal and urinary disorders | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| clostridium difficele infection |
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| weakness |
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| abdominal pain |
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| kidney stone |
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| no adverse event |
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| Enterococcus faecalis |
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| Extended spectrum beta lactamase Escherichia coli |
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| Other bacteria |
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| Strains pan sensitive to all antibiotics |
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| Strains resistant to trimethoprim |
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| Strains resistant to abx other than trimethoprim |
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