Urinary Tract InfectionsNCT02996981
Cranberry Effect on Urinary Tract Infections
An observational study of Urinary Tract Infections, run by TriHealth Inc..
Trial summary
This is a retrospective chart review using Electronic Privacy Identification Center (EPIC) database to determine if the addition of cranberry juice capsules to our discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery reduced the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- Type of treatment
- Pill or oral medicine
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2016to Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: All patients who underwent pelvic floor gynecologic surgery (for the indication of pelvic organ prolapse or stress urinary incontinence) performed by a physician at Cincinnati Urogynecology associates, TriHealth Inc between April 2015 and September 2015, and April 2016 and September 2016
Who may be able to join
- Underwent pelvic floor gynecologic surgery between April 2015 and September 2015, and April 2016 and September 2016
- Required indwelling urinary catheter use upon discharge from the hospital.
Who cannot join
- Intraoperative bladder injury, fistula repair, urethral diverticulectomy, or any other need for prolonged catheterization
- Complications in the 2 weeks following surgery requiring reoperation and subsequent catheter use
- Allergy to cranberry or its components
- Failure to present for both the two-week and six-week postoperative office visit
About this study
Official title: Do Cranberry Juice Capsules Reduce the Risk of Urinary Tract Infections in Patients With Indwelling Urinary Catheters Following Urogynecologic Surgery?
This is a retrospective chart review using Electronic Privacy Identification Center (EPIC) database to determine if the addition of cranberry juice capsules to our discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery reduced the incidence of UTI.
Read the detailed description
The incidence of urinary tract infection (UTI) in women undergoing pelvic floor gynecologic surgery is high, ranging from 10-64%. A recent randomized trial showed that cranberry juice capsules significantly reduced the incidence of UTI in patients undergoing elective gynecologic surgery (19% vs 38%; odds ratio 0.38 with confidence interval 0.19-0.79).
Cranberry juice capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016. Currently, all patients who undergo pelvic floor gynecologic surgery and are discharged from the hospital with an indwelling urinary catheter postoperatively are prescribed cranberry juice capsules to reduce the risk of UTI.
The purpose of this study is to determine if the addition of cranberry juice capsules to the discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery significantly reduced the incidence of UTI, compared to a separate cohort that did not have cranberry prescribed.
- Conditions
- Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cranberry group | Patients underwent pelvic floor gynecologic surgery performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc between April 2016 and September 2016 and discharged home with an indwelling urinary catheter following the surgery. This group of people had cranberry juice capsules prescribed. | |
| No cranberry group | Patients underwent pelvic floor gynecologic surgery performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc between April 2015 and September 2015. This group of people did not have cranberry juice capsules prescribed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of UTI
Measured: within 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start21 Nov 2016
- Primary completion14 Jul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Principal investigator, TriHealth - Cincinnati Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996981
- Sponsor's protocol ID
- 16-087
- Status last verified
- Oct 2022
- First submitted
- 15 Dec 2016
- Last updated
- 31 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shatkin-Margolis A, Warehime J, Pauls RN. Cranberry Supplementation Does Not Reduce Urinary Tract Infections in Patients With Indwelling Catheters After Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):130-134. doi: 10.1097/SPV.0000000000000507.
PubMed 29474286
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Cranberry Juice Capsules Reduce the Risk of Urinary Tract Infections in Patients With Indwelling Urinary Catheters Following Urogynecologic Surgery?
- ClinicalTrials.gov ID
- NCT02996981
- Acronym / sponsor ID
- 16-087
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 21 Nov 2016
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 31 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective chart review using Electronic Privacy Identification Center (EPIC) database to determine if the addition of cranberry juice capsules to our discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery reduced the incidence of UTI.
Detailed description
The incidence of urinary tract infection (UTI) in women undergoing pelvic floor gynecologic surgery is high, ranging from 10-64%. A recent randomized trial showed that cranberry juice capsules significantly reduced the incidence of UTI in patients undergoing elective gynecologic surgery (19% vs 38%; odds ratio 0.38 with confidence interval 0.19-0.79).
Cranberry juice capsules were incorporated into the standard practice of Cincinnati Urogynecology Associates, TriHealth Inc in mid-March 2016. Currently, all patients who undergo pelvic floor gynecologic surgery and are discharged from the hospital with an indwelling urinary catheter postoperatively are prescribed cranberry juice capsules to reduce the risk of UTI.
The purpose of this study is to determine if the addition of cranberry juice capsules to the discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery significantly reduced the incidence of UTI, compared to a separate cohort that did not have cranberry prescribed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry group | – | –Patients underwent pelvic floor gynecologic surgery performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc between April 2016 and September 2016 and discharged home with an indwelling urinary catheter following the surgery. This group of people had cranberry juice capsules prescribed. |
| No cranberry group | – | –Patients underwent pelvic floor gynecologic surgery performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc between April 2015 and September 2015. This group of people did not have cranberry juice capsules prescribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent pelvic floor gynecologic surgery (for the indication of pelvic organ prolapse or stress urinary incontinence) performed by a physician at Cincinnati Urogynecology associates, TriHealth Inc between April 2015 and September 2015, and April 2016 and September 2016
Key inclusion criteria (2 listed)
- Underwent pelvic floor gynecologic surgery between April 2015 and September 2015, and April 2016 and September 2016
- Required indwelling urinary catheter use upon discharge from the hospital.
Key exclusion criteria (4 listed)
- Intraoperative bladder injury, fistula repair, urethral diverticulectomy, or any other need for prolonged catheterization
- Complications in the 2 weeks following surgery requiring reoperation and subsequent catheter use
- Allergy to cranberry or its components
- Failure to present for both the two-week and six-week postoperative office visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Incidence of UTI
Time frame: within 6 weeks postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29474286Shatkin-Margolis A, Warehime J, Pauls RN. Cranberry Supplementation Does Not Reduce Urinary Tract Infections in Patients With Indwelling Catheters After Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):130-134. doi: 10.1097/SPV.0000000000000507.
- 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.
Rachel Pauls, MD principal investigator
TriHealth - Cincinnati Urogynecology Associates
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by TriHealth Inc..
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 31 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Incidence of UTI (time frame: within 6 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02996981, which also lists 1 linked publication.
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 31 Aug 2023.