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Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI)
The overall goal of this project is to assess the feasibility of a larger trial investigating the use of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day). Investigators plan to gain patient perspective regarding preferences for study design and assess associations between the treatments with changes in the postmenopausal urinary microbiome (urobiome).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Standard of care |
|
| Experimental | Experimental | Gentamicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamicin | Drug | administered via bladder |
| |
| Nitrofurantoin |
| Measure | Description | Time Frame |
|---|---|---|
| Assess feasibility of trial recruitment | measure screening ratio (number of people screened versus number enrolled) | 3 months |
| Examine treatment compliance | compare medication compliance between groups, as measured by weekly self-reported number of doses taken in the oral medication group and attendance at installation visits in the intravesical gentamicin group | 3 months |
| Examine trial retention | compare the proportion of participants retained in each group | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| culture-proven UTIs | 3 months | |
| Patient reported outcome measures | UTI Symptom Assessment | 6 weeks, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| urobiome analysis | bacterial presence | 6 weeks, 3 months |
| urobiome analysis | antimicrobial resistance gene presence | 6 weeks, 3 months |
Inclusion criteria:
Exclusion criteria:
postmenopausal women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital | Providence | Rhode Island | 02903 | 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 |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| D009582 | Nitrofurantoin |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009581 | Nitrofurans |
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| Drug |
administered PO |
|
| Patient reported outcome measures |
recurrent UTI symptom scale |
| 6 weeks, 3 months |
| Patient reported outcome measures | recurrent UTI impact questionaire | 6 weeks, 3 months |
| Patient reported outcome measures | short-form-36 | 6 weeks, 3 months |
| Patient reported outcome measures | general anxiety disorder-7 | 6 weeks, 3 months |
| Patient reported outcome measures | patient health questionnaire | 6 weeks, 3 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009574 |
| Nitro Compounds |
| D009930 | Organic Chemicals |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |