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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of UTI | within 6 weeks postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Pauls, MD | TriHealth - Cincinnati Urogynecology Associates | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29474286 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of UTI | Posted | Count of Participants | Participants | within 6 weeks postoperative |
|
From time of surgery to 12 weeks after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Pauls | TriHealth Inc. | 513-463-4300 | Rachel_Pauls@trihealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2016 | Aug 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | 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. | 0 | 71 | 0 | 71 | 0 | 71 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |