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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2022
  • participants needed
    142
  • sponsor
    Brigham and Women's Hospital
Updated on 26 January 2021
urinary tract infection
brimonidine tartrate ophthalmic solution
incontinence
prolapse
nitrofurantoin
cranberry extract
prophylaxis for urinary tract infection

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.

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.

Details
Condition Ptosis, Urinary Incontinence, Vaginal Vault Prolapse, Urinary tract infection, Genitourinary Prolapse, Recurrent Urinary Tract Infection, Recurrent Urinary Tract Infections, Urinary Tract Infections, pelvic organ prolapse, urinary tract infection (uti), urinary infection, recurrent utis
Treatment Nitrofurantoin Prophylaxis/Placebo, Cranberry capsules
Clinical Study IdentifierNCT03522961
SponsorBrigham and Women's Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Ptosis or Urinary tract infection or Genitourinary Prolapse or Urinary Tract Infections or Urinary Incontinence or Vaginal Vault Prolapse?
Do you have any of these conditions: pelvic organ prolapse or recurrent utis or urinary tract infection (uti) or urinary infection or Ptosis or Vaginal Vault Prolapse or Urinary Incontine...?
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
Clear my responses

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