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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nitrofurantoin
Secondary outcome measures
Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin
Number of postoperative UTIs
Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs
+3 moreTrial 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
1,609 Previous Clinical Trials
11,470,185 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
59 Patients Enrolled for Urinary Tract Infection
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have enrolled in this experiment thus far?
"Affirmative. Clinicaltrials.gov documents that this experiment commenced on August 15th 2018 and was recently updated in July 18th 2022, with 142 patients being recruited from a single medical centre."
Answered by AI
Are researchers currently seeking participants for this experiment?
"This clinical trial can be found on the website of clinicaltrials.gov, and it is actively recruiting participants at this time. The initial posting was made on 15th August 2018 with a recent update taking place on 18th July 2022."
Answered by AI
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