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Study never recruited
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Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.
Each participant once enrolled returns with an active Urinary Tract Infection (UTI), confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin treatment for 7 days, or intravesical gentamicin instillation once a day for three days. Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and with a repeated questionnaire for symptom relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nitrofurantoin | Active Comparator | Participants will randomized to oral nitrofurantoin |
|
| Intravesical Gentamicin | Active Comparator | Participants will be randomized to intravesical gentamicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrofurantoin | Drug | Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiologic effect of a chronic acute Urinary Tract Infection | Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days | baseline, 7-10 days |
| Change in symptomatic relief of a chronic acute Urinary Tract Infection | Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot) | baseline, 7-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| To establish the clinical FTE needs for providing urgent intravesical treatments | Nursing needs to provide intravesical treatments of acute Urinary Tract Infections (UTI) in women with chronic recurrent UTIs. Measured in amount of participants and FTE requirement for nursing staff. | baseline, through stufy completion, an average of one year |
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Inclusion Criteria:
Exclusion Criteria:
Premenopausal or perimenopausal healthy female patients with an active urinary tract infection and at least two symptomatic and culture-proven urinary tract infections within the past 12 months
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Lightner, MD | Mayo Clinic | Principal Investigator |
| Audrey N Schuetz, MD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D007239 | Infections |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D009582 | Nitrofurantoin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D005663 | Furans |
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| Gentamicin | Drug | Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days |
|
|
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |