Urinary Tract InfectionsNCT03522961
Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery
A study testing Cranberry capsules in people with Urinary Tract Infections and Pelvic Organ Prolapse, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections, Pelvic Organ Prolapse, Urinary Incontinence
- What is being tested?
- Cranberry capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- English-speaking
- Plan for pelvic organ prolapse (POP) or urinary incontinence (UI) surgery
Who cannot join
- Pregnancy
- Urethral diverticulectomy
- Urogenital fistula repair
- Sacral neuromodulation
- Congenital urogenital anomaly
- Allergy to cranberry products
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Being tested
- Nitrofurantoin Prophylaxis/Placebo, Cranberry capsules
- Medical subject headings
- Urinary Tract Infections, Pelvic Organ Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrofurantoin Prophylaxis/PlaceboDrug
Drug: Nitrofurantoin Drug: Placebo
Cranberry capsulesDrug
Drug: TheraCran® One Cranberry capsules
| Study group | Role | What they receive |
|---|---|---|
| Nitrofurantoin prophylaxis/Placebo | Active comparator | 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. Receives: Drug: Nitrofurantoin Prophylaxis/Placebo |
| Cranberry capsules | Active comparator | 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. Receives: Drug: Cranberry capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (6)
Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
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.
Measured: 28 days
Time to first postoperative UTI
Measured: 28 days
Number of postoperative UTIs
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start15 Aug 2018
- Primary completion30 Sep 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Theralogix LLC
- Responsible party
- Principal investigator, Jeannine Marie Miranne, Brigham and Women's Hospital
- Investigators
- Jeannine M Miranne, MD, MS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522961
- Sponsor's protocol ID
- 2017P002904
- Other IDs
- 016086
- Status last verified
- Nov 2025
- First submitted
- 17 Apr 2018
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery: a Double-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03522961
- Acronym / sponsor ID
- 2017P002904
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Theralogix LLC
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrofurantoin prophylaxis/Placebo | Active comparator | Drug: Nitrofurantoin Prophylaxis/PlaceboSubjects 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. |
| Cranberry capsules | Active comparator | Drug: Cranberry capsulesSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- English-speaking
- Plan for pelvic organ prolapse (POP) or urinary incontinence (UI) surgery
Key exclusion criteria (11 listed)
- Pregnancy
- Urethral diverticulectomy
- Urogenital fistula repair
- Sacral neuromodulation
- Congenital urogenital anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrofurantoin Prophylaxis/PlaceboDrug: Nitrofurantoin Drug: Placebo | Drug | Nitrofurantoin prophylaxis/Placebo |
| Cranberry capsulesDrug: TheraCran® One Cranberry capsules | Drug | Cranberry capsules |
Primary outcome
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.
6 secondary outcomes
Prevalence of bacterial resistance to nitrofurantoin on postoperative urine cultures for those participants who have culture-proven UTIs
Time frame: 28 days
Adherence to assigned treatment:cranberry capsule vs. nitrofurantoin
Time frame: 28 days
Reasons for non-adherence to assigned treatment
Time frame: 28 days
Risk factors for postoperative UTI
Time frame: 28 days
Time to first postoperative UTI
Time frame: 28 days
Number of postoperative UTIs
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannine M Miranne, MD, MS principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry capsules in people with Urinary Tract Infections and Pelvic Organ Prolapse, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.