Clinical trial NCT03522961: Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery
Official title: Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery: a Double-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Tract Infections
Pelvic Organ Prolapse
Urinary Incontinence
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Theralogix LLC
First posted: 2018-05-14
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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.
timeFrame: 28 days
Secondary outcomes:
measure: Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs
timeFrame: 28 days
measure: Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin
timeFrame: 28 days
measure: Reasons for non-adherence to assigned treatment
timeFrame: 28 days
measure: Risk factors for postoperative UTI
timeFrame: 28 days
measure: Time to first postoperative UTI
timeFrame: 28 days
measure: Number of postoperative UTIs
timeFrame: 28 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeannine M Miranne, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: