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

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ClinicalTrials.gov Identifier: NCT03522961
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
Theralogix LLC
Information provided by (Responsible Party):
Jeannine Marie Miranne, 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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Pelvic Organ Prolapse Urinary Incontinence Drug: Nitrofurantoin Prophylaxis/Placebo Drug: Cranberry capsules Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery: a Double-blinded Randomized Clinical Trial
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : July 9, 2020
Estimated Study Completion Date : July 9, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitrofurantoin prophylaxis/Placebo
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.
Drug: Nitrofurantoin Prophylaxis/Placebo
Drug: Nitrofurantoin Drug: Placebo

Active Comparator: Cranberry capsules
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.
Drug: Cranberry capsules
Drug: TheraCran® One Cranberry capsules




Primary Outcome Measures :
  1. 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. [ Time Frame: 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 Outcome Measures :
  1. Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs [ Time Frame: 28 days ]
  2. Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin [ Time Frame: 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.

  3. Reasons for non-adherence to assigned treatment [ Time Frame: 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.

  4. Risk factors for postoperative UTI [ Time Frame: 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.

  5. Time to first postoperative UTI [ Time Frame: 28 days ]
  6. Number of postoperative UTIs [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522961


Contacts
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Contact: Jeannine M Miranne, MD, MS 617-732-4838 Jmiranne@bwh.harvard.edu
Contact: Talar Abdalian, MS 617-732-4838 Tabdalian@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jeannine M Miranne, MD, MS    617-732-4838    jmiranne@bwh.harvard.edu   
Contact: Talar Abdalian, MS, BS    617-732-6281    tabdalian@bwh.harvrad.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Theralogix LLC
Investigators
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Principal Investigator: Jeannine M Miranne, MD, MS Brigham and Women's Hospital

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Responsible Party: Jeannine Marie Miranne, Urogynecologist; Assistant Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03522961     History of Changes
Other Study ID Numbers: 2017P002904
016086 ( Other Grant/Funding Number: Brigham and Women's Hospital OB/GYN Department )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Incontinence
Urinary Tract Infections
Lower Urinary Tract Symptoms
Anti-Infective Agents, Urinary
Enuresis
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical
Nitrofurantoin
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents