Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Overactive Bladder, Infectious Disease, Women's Studies, Urology, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Nephrology / Urology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/22/2018 |
| Start Date: | August 15, 2018 |
| End Date: | July 9, 2020 |
| Contact: | Jeannine M Miranne, MD, MS |
| Email: | Jmiranne@bwh.harvard.edu |
| Phone: | 617-732-4838 |
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.
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.
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.
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.
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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-4838
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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