Pelvic Organ Prolapse, Urinary Incontinence, Urinary Tract Infections
Conditions
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.
Interventions
DRUGNitrofurantoin Prophylaxis/Placebo
Drug: Nitrofurantoin Drug: Placebo
Drug: TheraCran® One Cranberry capsules
Sponsors
Theralogix LLC
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin | 28 days | A daily catheterization and medication diary will be used to track whether or not participants took their study medication every day for 28 days. Participants will bring their study medication bottle to every study visit and the medication will be counted by study staff to ensure adherence to assigned treatment. |
| Reasons for non-adherence to assigned treatment | 28 days | At office visits throughout the study period, after the participants' study medication is counted and non-adherence to assigned treatment is found, study physicians will ask participants for their reasons for non-adherence. |
| Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs | 28 days | — |
| Time to first postoperative UTI | 28 days | — |
| Number of postoperative UTIs | 28 days | — |
| Risk factors for postoperative UTI | 28 days | Risk factors for postoperative UTI will be assessed based on the participants' individual medical history and physical exam. Risk factors will be assessed by study physicians at office visits throughout the study period. |
Countries
United States
Outcome results
None listed