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

Primary Purpose

Urinary Tract Infections, Pelvic Organ Prolapse, Urinary Incontinence

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nitrofurantoin Prophylaxis/Placebo
Cranberry capsules
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nitrofurantoin prophylaxis/Placebo

Cranberry capsules

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs
Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin
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
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.
Risk factors for postoperative UTI
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.
Time to first postoperative UTI
Number of postoperative UTIs

Full Information

First Posted
April 17, 2018
Last Updated
August 25, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Theralogix LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03522961
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Theralogix LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Pelvic Organ Prolapse, Urinary Incontinence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nitrofurantoin prophylaxis/Placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cranberry capsules
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitrofurantoin Prophylaxis/Placebo
Intervention Description
Drug: Nitrofurantoin Drug: Placebo
Intervention Type
Drug
Intervention Name(s)
Cranberry capsules
Intervention Description
Drug: TheraCran® One Cranberry capsules
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs
Time Frame
28 days
Title
Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin
Description
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.
Time Frame
28 days
Title
Reasons for non-adherence to assigned treatment
Description
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.
Time Frame
28 days
Title
Risk factors for postoperative UTI
Description
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.
Time Frame
28 days
Title
Time to first postoperative UTI
Time Frame
28 days
Title
Number of postoperative UTIs
Time Frame
28 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannine M Miranne, MD, MS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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