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Cranberry powder capsules for Urinary Tract Infection (PUPS Trial)

Phase 2
Waitlist Available
Led By Betsy Foxman, PhD
Research Sponsored by Betsy Foxman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from surgery to post-op visit, approximately 6 weeks post surgery
Awards & highlights

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.

Eligible Conditions
  • Urinary Tract Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from surgery to post-op visit, approximately 6 weeks post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery to post-op visit, approximately 6 weeks post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urinary tract infection

Side effects data

From 2013 Phase 2 trial • 200 Patients • NCT01346774
24%
CONSTIPATION
23%
PAIN/PRESSURE/SORENESS
21%
EMESIS AND/OR NAUSEA
18%
URINARY ISSUES
16%
VAGINAL BLEEDING
15%
URINARY RETENTION
8%
VAGINAL DISCHARGE
8%
HEADACHE
6%
URINARY INCONTINENCE
6%
YEAST VAGINITIS
5%
HAIR LOSS
5%
ABDOMINAL PAIN/PRESSURE
5%
BUTTOCK/HIP PAIN
5%
PAIN/DISCOMFORT
5%
DIARRHEA/LOOSE STOOL
5%
SHORTNESS OF BREATH
4%
SUPRAPUBIC/PUBIC PAIN
4%
BLADDER SPASMS
4%
FATIGUE OR DECREASED ENERGY LEVEL
4%
HEMATURIA
4%
LIGHTHEADEDNESS
4%
URINARY FREQUENCY
4%
RASH
4%
ABNORMAL ECG
4%
DIZZINESS/VERTIGO
4%
BLOATING
4%
VAGINAL CHANGES
3%
MIGRAINES
3%
WEAKNESS
3%
MEMORY ISSUES
3%
BRONCHITIS
3%
VASOMOTOR SYMPTOMS
3%
INCISIONAL PAIN
3%
ACHY
3%
BACK PAIN
3%
VAGINAL PAN/PRESSURE
3%
ELEVATED WHITE BLOOD CELL COUNT
3%
ANEMIA
3%
VISION CHANGES/PROBLEMS
3%
ELEVATED LIVER FUNCTION TESTS
3%
GAS RETENTION
3%
GASTROENTERITIS
3%
GI ISSUES RELATED TO IBS
3%
HEMORRHOIDS
3%
SINUS SYMPTOMS
1%
HYPERTENSION
1%
CHANGE IN BOWEL MOVEMENTS
1%
ALLERGY
1%
Atypical migraine
1%
VESTIBULITIS
1%
ELEVATED GLUCOSE
1%
ELEVATED LABS
1%
TSH ELEVATED
1%
BLURRED VISION
1%
DRY EYE
1%
BUG BITE
1%
PAIN - POST OPERATIVE
1%
ONCHOLISIS
1%
SINUS PROBLEMS
1%
VIRAL SYNDRONE
1%
PAIN IN LOWER BACK
1%
LOW GRADE FEVER
1%
TOOTH ABSCESS
1%
RECTAL INDURATION
1%
TENDONITIS
1%
VAGINAL AND URETHRAL PAIN
1%
MOOD DISTURBANCE
1%
CATHETER DISCOMFORT
1%
URINARY URGENCY AND FREQUENCY
1%
ENLARGED UTERUS
1%
URINARY LEAKAGE
1%
BENIGN LESION
1%
BRUISING
1%
SWELLING
1%
VAGINAL BLEEDING POST OPERATIVELY
1%
CHRONIC HYPERTENSION
1%
VAGINAL ATROPHY
1%
ABNORMAL EKG
1%
Chest pain secondary to reflux (GERD)
1%
Transfusion related acute lung injury versus post operative pneumonia
1%
CATARACTS
1%
MEDICATION INTOLERANCE
1%
RECTAL HEMORRHAGE
1%
CHRONIC ENDOMETRITIS
1%
DIAGNOSIS OF METASTASIS OF COLON CANCER
1%
MIGRAINE
1%
TEETH PAIN
1%
LEFT NEUROPATHY DUE TO SURGICAL POSITIONING AND LENGTH OF CARE
1%
BLADDER ERYTHEMA
1%
VAGINAL IRRITATION
1%
VULVAR PRURITUS
1%
COUGHING EPISODES
1%
INCISION ISSUES
1%
KELOID
1%
LICHENS SCLEROSIS FLARE
1%
NAIL CHANGES
1%
PRURITIS
1%
SORE TEMPLE
1%
TISSUE BULGE
1%
EMOTIONAL STRESS
1%
ABDOMINAL PAIN POST OP
1%
EXTENSIVE ADHESIVE DISEASE
1%
SHOULDER PAIN
1%
LOW VITAMIN D LEVEL
1%
PRESSURE ON LEFT SIDE
1%
SUBSTANCE EXPOSURE
1%
BUTTOCKPAIN/LABIAL BURN
1%
CYSTOTOMY
1%
NEUROLOGIC PARENTHESES
1%
POST SITE HERNIA
1%
EYE PAIN
1%
POST OP PAIN VERSUS NEUROLOGIC/ NEUROPATHIC PAIN
1%
HEART PALPITATIONS
1%
ELEVATED TSH LEVELS
1%
WEIGHT GAIN
1%
MENTAL STATUS CHANGES
1%
CRAMPING WITH MINSES
1%
AIRWAY ISSUES
1%
LUNG ISSUES
1%
POST OP SWELLING
1%
VAGINAL SPOTTING
1%
Renal failure
1%
Pulmonary embolism
1%
COLD SYMPTOMS
1%
LEG NUMBNESS
1%
BLOODY NOSE
1%
ANGINA
1%
BRADYCARDIA
1%
PAIN BY LEFT HIP
1%
NAUSEA AND DIARRHEA
1%
LOWER QUADRANT DISCOMFORT
1%
LOWER BACK PACK
1%
LUMP IN LOWER ABDOMIN
1%
PAIN ON RIGHT SIDE
1%
PUDENDAL NEUROPATHY
1%
SLEEP APNEA-NEW DIAGNOSIS
1%
PAIN FORM DILATOR
1%
PAIN WITH ACTIVITY
1%
ABDOMINAL DISTENSION
1%
ABDOMINAL PAIN
1%
ABDOMINAL SWELLING
1%
BOWEL ISSUES
1%
C.DIFFICELE COLITIS
1%
CONSTIPATION AND OBSTIPATION
1%
CRAMPING
1%
DILATED TORTUOUS VESSELS IN THE RIGHT RETROPUBIC SPACE
1%
HYPOTENSION
1%
DISCOLORED FECES
1%
DYSPHAGIA
1%
FECAL INCONTINENCE
1%
GAS PAIN
1%
FECAL URGENCY
1%
HEARTBURN
1%
PELVIC PAIN V. POST OP DISCONFORT
1%
BLEEDING
1%
DIFFICULT VOIDING DUE TO SWELLING
1%
SORE THROAT
1%
UPPER RESPIRATORY INFECTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cranberry Capsules
Placebo Capsules

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cranberry powder capsulesExperimental Treatment1 Intervention
TheraCran® cranberry: based upon proanthocyanidin content, the four cranberry capsules are equivalent to two 8-ounce servings of cranberry juice. Participants were directed to take two capsules by mouth twice each day (once in the morning and once in the evening) starting at time of discharge for 4-6 weeks, or until their return for their post-operative doctor's visit. Participants were instructed to drink an 8 oz glass of water while taking the capsule with or without food.
Group II: Placebo capsulesPlacebo Group1 Intervention
Placebo: participants were directed to take two capsules by mouth twice each day (once in the morning and once in the evening) starting at time of discharge for 4-6 weeks, or until their return for their post-operative doctor's visit. Participants were instructed to drink an 8 oz glass of water while taking the capsule with or without food.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cranberry powder capsules
2011
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Betsy FoxmanLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,691 Total Patients Enrolled
7 Trials studying Urinary Tract Infection
1,369 Patients Enrolled for Urinary Tract Infection
University of MichiganOTHER
1,833 Previous Clinical Trials
6,422,928 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
40 Patients Enrolled for Urinary Tract Infection
~14 spots leftby Sep 2025
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