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

Sponsors

Lead Sponsor: Brigham and Women's Hospital

Collaborator: Theralogix LLC

Source Brigham and Women's Hospital
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.

Overall Status Recruiting
Start Date August 15, 2018
Completion Date July 31, 2022
Primary Completion Date July 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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. 28 days
Secondary Outcome
Measure 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 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
Number of postoperative UTIs 28 days
Enrollment 142
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nitrofurantoin Prophylaxis/Placebo

Description: Drug: Nitrofurantoin Drug: Placebo

Arm Group Label: Nitrofurantoin prophylaxis/Placebo

Intervention Type: Drug

Intervention Name: Cranberry capsules

Description: Drug: TheraCran® One Cranberry capsules

Arm Group Label: Cranberry capsules

Eligibility

Criteria:

Inclusion Criteria: - Age ≥ 18 - English-speaking - Plan for POP or 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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jeannine M Miranne, MD, MS Principal Investigator Brigham and Women's Hospital
Overall Contact

Last Name: Jeannine M Miranne, MD, MS

Phone: 617-732-4838

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Brigham and Women's Hospital Jeannine M Miranne, MD, MS 617-732-4838 [email protected]
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Brigham and Women's Hospital

Investigator Full Name: Jeannine Marie Miranne

Investigator Title: Urogynecologist; Assistant Professor, Harvard Medical School

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Nitrofurantoin prophylaxis/Placebo

Type: Active Comparator

Description: 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.

Label: Cranberry capsules

Type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov