Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery

Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery: a Double-blinded Randomized Clinical Trial

We aim to compare the effectiveness of cranberry capsules versus nitrofurantoin prophylaxis in preventing urinary tract infections (UTIs) after urogynecologic surgery by conducting a double-blinded randomized clinical trial involving women with pelvic organ prolapse and/or urinary incontinence scheduled to have surgery with the Urogynecologists who comprise the Brigham and Women's Urogynecology Group.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Urinary Tract Infections
• Intervention / Treatment: Drug: Nitrofurantoin Prophylaxis/Placebo; Drug: Cranberry capsules

Detailed Description

We plan to conduct a double-blinded randomized clinical trial involving women who undergo surgery for pelvic organ prolapse and/or urinary incontinence.

Participants who need transurethral catheterization postoperatively will be randomized to cranberry capsules or nitrofurantoin prophylaxis. Randomization will be performed the day of discharge. Both participants and surgeons will be blinded to treatment allocation. All participants will receive routine perioperative intravenous antibiotic prophylaxis.

Participants who fail their voiding trial after surgery and require transurethral catheterization upon discharge from the hospital will be randomized to either one cranberry capsule (TheraCran one®, Theralogix, LLC, Rockville, Maryland) or one 100 mg capsule of nitrofurantoin by mouth daily beginning postoperative day #1. Participants randomized to the cranberry capsule group will continue to take one cranberry capsule daily for 28 days. Participants randomized to the nitrofurantoin group will continue to take 100 mg of nitrofurantoin each day transurethral catheterization is needed for up to 28 days. All participants will be scheduled for a repeat voiding trial within 48 hours to 1 week after discharge.

All participants will complete a daily catheterization and medication diary to record the type of catheterization used (indwelling or intermittent) and to confirm they are taking the study medication for the duration of the study period. They will also be asked to record any urinary symptoms they experience and will be encouraged to contact the office immediately if they experience urinary symptoms consistent with a UTI.

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeannine M Miranne, MD, MS; Phone Number: 617-732-4838; Email: jmiranne@bwh.harvard.edu
• Study Contact Backup: Name: Alexa Courtepatte; Phone Number: 617-732-4838; Email: acourtepatte@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18
• English-speaking
• Plan for pelvic organ prolapse (POP) or urinary incontinence (UI) surgery

Exclusion Criteria:

• Pregnancy
• Urethral diverticulectomy
• Urogenital fistula repair
• Sacral neuromodulation
• Congenital urogenital anomaly
• Allergy to cranberry products
• Allergy to nitrofurantoin
• Dependent on catheterization preoperatively
• Recurrent UTI's (3 or more culture proven UTI's over the past consecutive 12 months)
• Known creatinine clearance <60 mL/min
• Non-English, Non-Spanish speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nitrofurantoin prophylaxis/Placebo; 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.	Drug: Nitrofurantoin Prophylaxis/Placebo; Drug: Nitrofurantoin Drug: Placebo
Active Comparator: Cranberry capsules; 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.	Drug: Cranberry capsules; Drug: TheraCran® One Cranberry capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome will be treatment for clinically suspected or culture-proven UTI in the cranberry capsule group versus the nitrofurantoin group within 4 weeks (28 days) after surgery.	Clinically suspected treatment will include both empiric treatment based on the development of urinary symptoms alone (dysuria, urinary urgency, and/or urinary frequency) or prescribed based on symptoms suggestive of a UTI and the presence of nitrites and/or leukocyte esterase on urine dipstick analysis. Participants will fill out a daily catheterization and medication diary which asks about the presence or absence of UTI symptoms. They will be encouraged to call the office and/or come in for evaluation if they experience these symptoms. These participants may be treated based on their symptoms alone or based on their symptoms and the presence of nitrites and/or leukocyte esterase on urine dipstick analysis. A culture-proven UTI will be defined as a urine culture result with >100,000 colony-forming units of a single organism.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs		28 days
Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin	A daily catheterization and medication diary will be used to track whether or not participants took their study medication every day for 28 days. Participants will bring their study medication bottle to every study visit and the medication will be counted by study staff to ensure adherence to assigned treatment.	28 days
Reasons for non-adherence to assigned treatment	At office visits throughout the study period, after the participants' study medication is counted and non-adherence to assigned treatment is found, study physicians will ask participants for their reasons for non-adherence.	28 days
Risk factors for postoperative UTI	Risk factors for postoperative UTI will be assessed based on the participants' individual medical history and physical exam. Risk factors will be assessed by study physicians at office visits throughout the study period.	28 days
Time to first postoperative UTI		28 days
Number of postoperative UTIs		28 days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Theralogix LLC
• Investigators: Principal Investigator: Jeannine M Miranne, MD, MS, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease Attributes; Urination Disorders; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Infections; Communicable Diseases; Prolapse; Pelvic Organ Prolapse; Urinary Tract Infections; Anti-Infective Agents; Anti-Bacterial Agents; Anti-Infective Agents, Urinary; Nitrofurantoin
• Other Study ID Numbers: 2017P002904; 016086 (Other Grant/Funding Number: Brigham and Women's Hospital OB/GYN Department)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No