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

NCT03522961 | Active Not Recruiting

• 2 other identifiers: 2017P002904016086
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infections; Pelvic Organ Prolapse; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  28 days

• Reasons for non-adherence to assigned treatment

  28 days

• Risk factors for postoperative UTI

  28 days

• Time to first postoperative UTI

  28 days

Study Arms (2)

Nitrofurantoin prophylaxis/Placebo

ACTIVE COMPARATOR

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

Cranberry capsules

ACTIVE COMPARATOR

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

Interventions

Nitrofurantoin Prophylaxis/Placebo DRUG

Drug: Nitrofurantoin Drug: Placebo

Nitrofurantoin prophylaxis/Placebo

Cranberry capsules DRUG

Drug: TheraCran® One Cranberry capsules

Cranberry capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Theralogix LLC: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Pelvic Organ Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Jeannine M Miranne, MD, MS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urogynecologist; Assistant Professor, Harvard Medical School

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 14, 2018
• Study Start: August 15, 2018
• Primary Completion: September 30, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)