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This is a research study that aims to determine if antibiotic bladder instillations (placing an antibiotic directly into the bladder) over several sessions at the office is a good option to prevent recurrent urinary tract infections, in comparison with oral suppression therapy (taking daily antibiotics in the form of pills by mouth). Oral antibiotic suppression therapy is currently the most common treatment route for recurrent urinary tract infections in post-menopausal women. The bladder antibiotic instillation may overcome the disadvantages of oral suppression therapy such as antibiotic resistance, certain side effects, and recurrence of infections after finishing the treatment course.
In this study, the investigators aim to determine the effectiveness of intra-vesical antibiotic instillations for the prophylactic treatment of recurrent urinary tract infections in menopausal women in comparison with oral suppressive therapy. This is a parallel un-blinded randomized-controlled trial. the investigators will randomize post-menopausal women with recurrent urinary tract infections to either receive 6-8 intra-vesical antibiotic instillations at the office or to receive 3 months of oral antibiotic suppressive therapy.
In the bladder instillation arm, based on the participant's allergy and antibiotic resistance profile, one of the following three antibiotics will be instilled intravesically via a latex free BARD® 12 French Foley catheter for a total of 6-8 instillations (2 instillations/week) according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol:
In the antibiotic oral suppression therapy arm, one of the following routinely used antibiotics will be prescribed for a total of 3 months according to the American Urogynecology Society Guidelines and based on the participant's allergy and antibiotic resistance profile:
Participants will be followed for total of 3 months after finishing either treatment course by only reviewing their medical records to collect data regarding development of urinary tract infections after treatment.
Primary endpoint/outcome:
• To compare the number of women developing urinary tract infections during the 3 months following treatment between the two groups.
Secondary endpoints/outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravesical antibiotic instillation | Active Comparator |
| |
| Oral antibiotic suppressive therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravesical antibiotic instillation | Drug | Based on the participant's allergy and antibiotic resistance profile, one of the following three antibiotics will be instilled intravesically via a latex free BARD® 12 French Foley catheter for a total of 6-8 instillations (2 instillations/week) according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol:
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of participants with urinary tract infections following treatment course | To compare the percentage of women developing urinary tract infections during the 3 months following treatment between the two groups. | Assessed starting immediately after the treatment is completed for a total of 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of antibiotic resistance of pathogens in participants developing urinary tract infections after completing the treatment course. | To compare the rate of antibiotic resistance of isolated pathogens when participants develop a urinary tract infection during the 3 months follow up period after intra-vesical antibiotic instillation vs. oral antibiotic suppressive therapy. the percentage of antibiotics on the susceptibility list of urine cultures will be compared between participants developing urinary tract infection in each group during the 3 months follow-up period after completing the treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Sabatino, MPH | Contact | 973-971-7361 | caroline.sabatino@atlantichealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Charbel Salamon, MD, MS | Atlantic Health System - Morristown Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31990805 | Background | Chernyak S, Salamon C. Intravesical Antibiotic Administration in the Treatment of Recurrent Urinary Tract Infections: Promising Results From a Case Series. Female Pelvic Med Reconstr Surg. 2020 Feb;26(2):152-154. doi: 10.1097/SPV.0000000000000810. |
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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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|
| Antibiotic oral suppressive therapy | Drug | In the antibiotic oral suppression therapy arm, one of the following routinely used antibiotics will be prescribed for a total of 3 months according to the American Urogynecology Society Guidelines and based on the participant's allergy and antibiotic resistance profile:
|
|
| Assessed starting immediately after the treatment is completed for a total of 3 months |
| the percentage of patients developing side effects of the 2 treatments | To compare the percentage of patients developing side effects between the two treatment modalities. At their routine follow up visits patients will be asked about whether or not they developed side effects and the type and severity of side effects of the treatment received. The percentage of patients developing side effects (per type and severity) in each arm will be compared. | From the date of randomization until the date of first documented side effect assessed up to 3 months after the treatment is completed in each arm |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |