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

NCT ID: NCT03522961

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Urinary Tract Infections; Pelvic Organ Prolapse; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nitrofurantoin Prophylaxis/Placebo

Intervention Type: DRUG

Drug: Nitrofurantoin Drug: Placebo

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.

Group Type: ACTIVE_COMPARATOR

Cranberry capsules

Intervention Type: DRUG

Drug: TheraCran® One Cranberry capsules

Interventions

Nitrofurantoin Prophylaxis/Placebo

Drug: Nitrofurantoin Drug: Placebo

Intervention Type: DRUG

Cranberry capsules

Drug: TheraCran® One Cranberry capsules

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Theralogix LLC

UNKNOWN

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeannine Marie Miranne

Urogynecologist; Assistant Professor, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeannine M Miranne, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2017P002904

Identifier Type: -

Identifier Source: org_study_id

016086

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id