Urinary Tract Infection
Conditions
Keywords
cystitis, pyelonephritis, bladder infection, kidney infection
Brief summary
Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (CAUTI) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery. Cranberry products provide alternative means for preventing CAUTI and could result in decreased use of antimicrobials. In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to take either cranberry powder capsules or placebo powder capsules. The low risk of harm associated with using cranberry to reduce UTI coupled with its potential benefit makes it a desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot /feasibility study will prepare us for the conduct of a large scale clinical trial.
Detailed description
Cranberry products prevent bacteria that cause UTI, especially Escherichia coli, from adhering to bladder cell wall thus preventing infection. Adherence of type 1 pili is inhibited by the fructose and of p pili by the proanthocyanidins present in cranberry.
Interventions
DRUGCranberry powder capsules
2 cranberry powder capsules twice a day
DRUGPlacebo powder capsules
2 placebo capsules twice a day
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Betsy Foxman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Presenting at the gynecology clinic for a pre-operatory visit 2. Ability to give informed consent 3. Willing to take cranberry capsules for up to 6 weeks 4. 18 of age or older
Exclusion criteria
1. Pregnancy 2. History of nephrolithiasis 3. History of allergy to cranberry 4. Patient on anticoagulant medicine to be re-started during the 4-6 weeks after surgery 5. Less than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Clinically-diagnosed and Treated UTI's. | From surgery to post-op visit, approximately 6 weeks post surgery | The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at their preoperative appointment for gynecological surgery. At enrollment they completed a questionnaire about their history and signed an informed consent form. Participants were not assigned to a treatment arm until the day of their surgery.
Pre-assignment details
If a participant's surgery was canceled or she failed to complete her enrollment questionnaire she was not assigned to a treatment arm. 200 women were consented, 160 were randomly assigned to treatment (80 cranberry, 80 placebo).
Participants by arm
| Arm | Count |
|---|---|
| Cranberry Capsules Cranberry powder: 2 cranberry powder capsules twice a day | 80 |
| Placebo Placebo powder: 2 placebo powder capsules twice a day | 80 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Did not take a single dose | 6 | 4 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Cranberry Capsules | Placebo | Total |
|---|---|---|---|
| Age, Customized 18 - 60 years | 47 participants | 48 participants | 95 participants |
| Age, Customized > 60 years | 33 participants | 32 participants | 65 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 77 Participants | 152 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Ever experienced UTI in life | 49 participants | 50 participants | 99 participants |
| Experienced a UTI in the past 12 mo | 18 participants | 19 participants | 37 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 69 Participants | 72 Participants | 141 Participants |
| Reasons for surgery Abnormal uterine bleeding | 11 participants | 6 participants | 17 participants |
| Reasons for surgery Adnexal mass | 4 participants | 4 participants | 8 participants |
| Reasons for surgery Chronic pelvic pain | 2 participants | 3 participants | 5 participants |
| Reasons for surgery Endometriosis | 0 participants | 2 participants | 2 participants |
| Reasons for surgery Fibroids | 11 participants | 9 participants | 20 participants |
| Reasons for surgery Other | 9 participants | 18 participants | 27 participants |
| Reasons for surgery Pelvic organ prolapse | 51 participants | 56 participants | 107 participants |
| Reasons for surgery Stress urinary incontinence | 21 participants | 23 participants | 44 participants |
| Region of Enrollment United States | 80 participants | 80 participants | 160 participants |
| Sex: Female, Male Female | 80 Participants | 80 Participants | 160 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of Surgery Hysterectomy/other extirpative | 35 participants | 42 participants | 77 participants |
| Type of Surgery Other | 4 participants | 4 participants | 8 participants |
| Type of Surgery Prolapse/reconstructive | 52 participants | 58 participants | 110 participants |
| Type of Surgery Urinary incontinence operation | 24 participants | 24 participants | 48 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 75 / 80 | 78 / 80 |
| serious Total, serious adverse events | 4 / 80 | 4 / 80 |
Outcome results
Primary
Participants With Clinically-diagnosed and Treated UTI's.
The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records.
Time frame: From surgery to post-op visit, approximately 6 weeks post surgery
Population: Analysis was run on all 160 subjects that were ascribed to an arm of the study. Data were analyzed using an intent to treat protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cranberry Capsules | Participants With Clinically-diagnosed and Treated UTI's. | 15 participants |
| Placebo | Participants With Clinically-diagnosed and Treated UTI's. | 30 participants |