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Cranberry vs Nitrofurantoin for Urinary Tract Infection Prevention
N/A
Waitlist Available
Led By Jeannine M Miranne, MD, MS
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Summary
This trial will compare the effectiveness of cranberry capsules and nitrofurantoin in preventing urinary tract infections after urogynecologic surgery.
Who is the study for?
This trial is for English-speaking women aged 18 or older who are planning surgery for pelvic organ prolapse or urinary incontinence. It's not suitable for pregnant women, those dependent on catheterization before surgery, with a low kidney function (creatinine clearance <60 mL/min), recurrent UTIs, congenital anomalies, or allergies to cranberries or nitrofurantoin.
What is being tested?
The study compares the use of cranberry capsules versus nitrofurantoin (an antibiotic) to prevent urinary tract infections after urogynecologic surgery. Participants will be randomly assigned to one of these treatments in a double-blind setup where neither they nor the researchers know who gets which treatment.
What are the potential side effects?
Cranberry capsules may cause mild stomach upset and diarrhea. Nitrofurantoin can lead to side effects like nausea, headache, dizziness, and rarely lung problems or liver issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Nitrofurantoin
Secondary study objectives
Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin
Reasons for non-adherence to assigned treatment
Risk factors for postoperative UTI
Trial Design
2Treatment groups
Active Control
Group I: Cranberry capsulesActive Control1 Intervention
Subjects will receive TheraCran® One Cranberry 36mg capsules (Bottle A) once a day until they pass their voiding trial and no longer require transurethral catheterization. Subjects will be switched to another bottle of TheraCran® One Cranberry 36mg capsules (Bottle B) once a day, starting the day after they pass their voiding trial until the end of the 28 day study period.
Group II: Nitrofurantoin prophylaxis/PlaceboActive Control1 Intervention
Subjects will receive Nitrofurantoin 100mg capsules (Bottle A) once a day until they pass their voiding trial and no longer require transurethral catheterization. Subjects will be switched to Placebo capsules (Bottle B) once a day, starting the day after they pass their voiding trial until the end of the 28 day study period.
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Who is running the clinical trial?
Theralogix LLCUNKNOWN
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,482 Total Patients Enrolled
Jeannine M Miranne, MD, MSPrincipal InvestigatorBrigham and Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to use a catheter before surgery.Your kidneys do not filter waste products well (creatinine clearance <60 mL/min).This criterion is not clear and seems to be incomplete. Can you provide more context or specific details for this criterion?You have had surgery to repair a connection between the urinary and genital systems.This criterion is not clear. Can you provide more context or details?You have had three or more confirmed urinary tract infections in the past year.You have plans for surgery to treat pelvic organ prolapse or urinary incontinence.You were born with a urinary or reproductive system problem.You are allergic to cranberry products.You are allergic to nitrofurantoin.
Research Study Groups:
This trial has the following groups:- Group 1: Cranberry capsules
- Group 2: Nitrofurantoin prophylaxis/Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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