Ignite Creation Date:
2024-05-06 @ 2:20 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04285320
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2020-02-17
Brief Title:
Antibiotic Bladder Instillations vs Oral Suppression for the Treatment of Recurrent Urinary Tract Infections
Sponsor:
Atlantic Health System
Organization:
Atlantic Health System
Study Overview
Official Title:
Intravesical Antibiotic Instillations Versus Oral Suppression for the Treatment of Recurrent Urinary Tract Infections in Post-menopausal Women
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 participants 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 instillationsweek according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol
Amikacin-30 mg in 60 ml of sterile water
Gentamycin-80mg in 60ml sterile water
Tobramycin-80 mg in 100 ml of sterile water
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 participants allergy and antibiotic resistance profile
Trimethoprim daily 100 mg
Trimethoprimsulfamethoxazole daily 40 mg200 mg
Trimethoprimsulfamethoxazole every 3 days 40 mg200 mg
Nitrofurantoin monohydratemacrocrystals daily 50 mg
Nitrofurantoin monohydratemacrocrystals daily 100 mg
Cephalexin daily 125 mg
Cephalexin daily 250 mg
Fosfomycin every 10 days 3 grams All medications used in this study are approved by the FDA to treat urinary tract infections
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 endpointoutcome
To compare the number of women developing urinary tract infections during the 3 months following treatment between the two groups
Secondary endpointsoutcomes
To compare the rate of antibiotic resistance of isolated pathogens after intravesical antibiotic instillation vs oral antibiotic suppressive therapy
To compare side effects of the two treatment modalities
In the bladder instillation arm based on the participants 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 instillationsweek according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol
Amikacin-30 mg in 60 ml of sterile water
Gentamycin-80mg in 60ml sterile water
Tobramycin-80 mg in 100 ml of sterile water
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 participants allergy and antibiotic resistance profile
Trimethoprim daily 100 mg
Trimethoprimsulfamethoxazole daily 40 mg200 mg
Trimethoprimsulfamethoxazole every 3 days 40 mg200 mg
Nitrofurantoin monohydratemacrocrystals daily 50 mg
Nitrofurantoin monohydratemacrocrystals daily 100 mg
Cephalexin daily 125 mg
Cephalexin daily 250 mg
Fosfomycin every 10 days 3 grams All medications used in this study are approved by the FDA to treat urinary tract infections
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 endpointoutcome
To compare the number of women developing urinary tract infections during the 3 months following treatment between the two groups
Secondary endpointsoutcomes
To compare the rate of antibiotic resistance of isolated pathogens after intravesical antibiotic instillation vs oral antibiotic suppressive therapy
To compare side effects of the two treatment modalities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None