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Preventing Urinary Tract Infection Post-Surgery (PUPS)

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ClinicalTrials.gov Identifier: NCT01346774
Recruitment Status : Completed
First Posted : May 3, 2011
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Information provided by (Responsible Party):
Betsy Foxman, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Urinary Tract Infection
Interventions Drug: Cranberry powder capsules
Drug: Placebo powder capsules
Enrollment 200
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).

Arm/Group Title Cranberry Capsules Placebo
Hide Arm/Group Description Cranberry powder: 2 cranberry powder capsules twice a day Placebo powder: 2 placebo powder capsules twice a day
Period Title: Overall Study
Started 80 80
Completed 67 63
Not Completed 13 17
Reason Not Completed
Did not take a single dose             6             4
Lost to Follow-up             3             4
Withdrawal by Subject             1             4
Protocol Violation             2             3
Adverse Event             1             2
Arm/Group Title Cranberry Capsules Placebo Total
Hide Arm/Group Description Cranberry powder: 2 cranberry powder capsules twice a day Placebo powder: 2 placebo powder capsules twice a day Total of all reporting groups
Overall Number of Baseline Participants 80 80 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
18 - 60 years 47 48 95
> 60 years 33 32 65
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Female
80
 100.0%
80
 100.0%
160
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Hispanic or Latino
2
   2.5%
1
   1.3%
3
   1.9%
Not Hispanic or Latino
75
  93.8%
77
  96.3%
152
  95.0%
Unknown or Not Reported
3
   3.8%
2
   2.5%
5
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   5.0%
5
   6.3%
9
   5.6%
White
69
  86.3%
72
  90.0%
141
  88.1%
More than one race
5
   6.3%
3
   3.8%
8
   5.0%
Unknown or Not Reported
2
   2.5%
0
   0.0%
2
   1.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 80 participants 80 participants 160 participants
80 80 160
Experienced a UTI in the past 12 mo   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
18 19 37
[1]
Measure Description: Participant has experienced UTI in the 12 months prior to her gynecologic surgery.
Ever experienced UTI in life   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
49 50 99
[1]
Measure Description: Participant has experienced UTI at least once in her lifetime prior to her gynecologic surgery.
Reasons for surgery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Fibroids 11 9 20
Pelvic organ prolapse 51 56 107
Stress urinary incontinence 21 23 44
Chronic pelvic pain 2 3 5
Endometriosis 0 2 2
Abnormal uterine bleeding 11 6 17
Adnexal mass 4 4 8
Other 9 18 27
[1]
Measure Description: Categories are not mutually exclusive. Participants may have had more than one reason for surgery.
Type of Surgery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 80 participants 160 participants
Urinary incontinence operation 24 24 48
Prolapse/reconstructive 52 58 110
Hysterectomy/other extirpative 35 42 77
Other 4 4 8
[1]
Measure Description: Categories are not mutually exclusive; participants may have required more than one type of surgery.
1.Primary Outcome
Title Participants With Clinically-diagnosed and Treated UTI's.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cranberry Capsules Placebo
Hide Arm/Group Description:
Cranberry powder: 2 cranberry powder capsules twice a day
Placebo powder: 2 placebo powder capsules twice a day
Overall Number of Participants Analyzed 80 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
15
(11.71 to 28.66)
30
(27.69 to 48.45)
Time Frame Adverse Events data were collected beginning at time of randomization (admitted to surgery) and ended 30 days after their postoperative visit when study treatment ended (a total time period of 8-10 weeks).
Adverse Event Reporting Description Adverse Events (AE) data were gathered via scheduled followup phone calls with participants and medical record review. UTI was an outcome and so was not reported as AE unless other pertinent symptoms occurred. Some severe AE's reported occurred before randomization but are reported here due to their severe nature.
 
Arm/Group Title Cranberry Capsules Placebo Capsules
Hide Arm/Group Description Cranberry powder: 2 cranberry powder capsules twice a day Placebo powder: 2 placebo powder capsules twice a day
All-Cause Mortality
Cranberry Capsules Placebo Capsules
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cranberry Capsules Placebo Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/80 (5.00%)      4/80 (5.00%)    
Blood and lymphatic system disorders     
Altered mental status and progressive fatigue due to chronic anemia  [1]  0/80 (0.00%)  0 1/80 (1.25%)  1
Gastrointestinal disorders     
Incarcerated hernia, small bowel obstruction   0/80 (0.00%)  0 1/80 (1.25%)  1
Chest pain secondary to reflux (GERD)  [2]  1/80 (1.25%)  1 0/80 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoarthritis   0/80 (0.00%)  0 1/80 (1.25%)  1
Right hip fracture  [3]  0/80 (0.00%)  0 1/80 (1.25%)  1
Vertebral compression fracture  [4]  0/80 (0.00%)  0 1/80 (1.25%)  1
Nervous system disorders     
Atypical migraine  [5]  1/80 (1.25%)  1 0/80 (0.00%)  0
Renal and urinary disorders     
UTI  [6]  0/80 (0.00%)  0 1/80 (1.25%)  1
Renal failure  [7]  1/80 (1.25%)  1 0/80 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolus in Right Lower Lobe  [8]  0/80 (0.00%)  0 1/80 (1.25%)  1
Transfusion related acute lung injury versus post operative pneumonia  [9]  1/80 (1.25%)  1 0/80 (0.00%)  0
Pulmonary embolism   1/80 (1.25%)  1 0/80 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Participant told pups that she started feeling disoriented, tired and could not talk in the morning. She went to the hospital and was admitted for two days. She underwent a blood transfusion and received two pints of blood.
[2]
The participant was admitted to the chest pain center in stable condition.
[3]
hip repair previous to gynecological surgery and study drug.
[4]
Participant said she had back pain and found out it was a fracture. She had a vertebroplasty compression. Participant said that the back pain went away 2 days after the procedure. She was given oxycontin and Flexeril
[5]
While watching television she had a sudden headache `all over` along with a sore feeling in both her eyes, as well as one bout of emesis. Headaches continued in the morning so she went to emergency dept. She does not have any other meningeal signs.
[6]
hospital re-admission.
[7]
Surgery was not performed and PARTICIPANT NEVER RECEIVED STUDY DRUG
[8]
Participant did not recover well from operation for incarcerated hernia so she has a CT scan that showed acute pulmonary embolus in the right lower lobe pulmonary artery branches.
[9]
PARTICIPANT DID NOT TAKE STUDY DRUG. Participant was kept in the hospital after gynecologic because of transfusion related acute lung injury.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cranberry Capsules Placebo Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/80 (93.75%)      78/80 (97.50%)    
Blood and lymphatic system disorders     
ABNORMAL LAB RESULTS   0/80 (0.00%)  0 2/80 (2.50%)  2
ANEMIA   2/80 (2.50%)  2 1/80 (1.25%)  1
BLEEDING   0/80 (0.00%)  0 2/80 (2.50%)  2
BLOODY NOSE   1/80 (1.25%)  1 0/80 (0.00%)  0
BUMP-LEFT GROIN AREA   0/80 (0.00%)  0 1/80 (1.25%)  1
EDEMA (ONE SPECIFIED AS BILATERAL)   0/80 (0.00%)  0 3/80 (3.75%)  3
ELEVATED CHOLESTEROL   0/80 (0.00%)  0 1/80 (1.25%)  1
ELEVATED LABS   1/80 (1.25%)  1 0/80 (0.00%)  0
ELEVATED WHITE BLOOD CELL COUNT   2/80 (2.50%)  2 2/80 (2.50%)  2
LOW HEMATOCRIT LEVELS   0/80 (0.00%)  0 1/80 (1.25%)  1
SUBSTANCE EXPOSURE   1/80 (1.25%)  1 0/80 (0.00%)  0
SUPERFICIAL PHLEBITIS   0/80 (0.00%)  0 1/80 (1.25%)  1
SWELLING   0/80 (0.00%)  0 1/80 (1.25%)  1
VAGINAL SPOTTING   1/80 (1.25%)  1 0/80 (0.00%)  0
Cardiac disorders     
ABNORMAL ECG   3/80 (3.75%)  3 7/80 (8.75%)  7
ABNORMAL EKG   1/80 (1.25%)  1 1/80 (1.25%)  1
ANGINA   1/80 (1.25%)  1 0/80 (0.00%)  0
BLOOD PRESSURE PROBLEMS   0/80 (0.00%)  0 1/80 (1.25%)  1
BRADYCARDIA   1/80 (1.25%)  1 0/80 (0.00%)  0
CARDIAC ABNORMALITIES   0/80 (0.00%)  0 1/80 (1.25%)  1
CHEST PAIN   0/80 (0.00%)  0 1/80 (1.25%)  1
HEART PALPITATIONS   1/80 (1.25%)  1 0/80 (0.00%)  0
HYPERTENSION   1/80 (1.25%)  1 2/80 (2.50%)  2
T-WAVE ABNORMALITY, T WAVE INVERSIONS IN LEADS III AND AVF   0/80 (0.00%)  0 1/80 (1.25%)  1
Ear and labyrinth disorders     
VERTIGO   0/80 (0.00%)  0 1/80 (1.25%)  1
VESTIBULITIS   1/80 (1.25%)  2 0/80 (0.00%)  0
Endocrine disorders     
ELEVATED GLUCOSE   1/80 (1.25%)  1 3/80 (3.75%)  3
ELEVATED LABS   1/80 (1.25%)  1 0/80 (0.00%)  0
ELEVATED TSH LEVELS   1/80 (1.25%)  1 0/80 (0.00%)  0
PERIMENOPAUSAL SYNDROME   0/80 (0.00%)  0 1/80 (1.25%)  1
PRIMARY HYPERPARATHYROIDISM   0/80 (0.00%)  0 1/80 (1.25%)  1
TENDERNESS IN AXILLA   0/80 (0.00%)  0 1/80 (1.25%)  1
TSH ELEVATED   1/80 (1.25%)  1 0/80 (0.00%)  0
VAGINAL ATROPHY   1/80 (1.25%)  1 0/80 (0.00%)  0
VASOMOTOR SYMPTOMS   2/80 (2.50%)  2 8/80 (10.00%)  8
VASOVAGAL EPISODE   0/80 (0.00%)  0 1/80 (1.25%)  1
Eye disorders     
BLURRED VISION   1/80 (1.25%)  1 0/80 (0.00%)  0
CATARACTS   1/80 (1.25%)  1 0/80 (0.00%)  0
CORNEAL ABRASION   0/80 (0.00%)  0 2/80 (2.50%)  2
DISLOCATED INTRAOCULAR LENS IN CAPSULAR BAG OS   0/80 (0.00%)  0 1/80 (1.25%)  1
DRY EYE   1/80 (1.25%)  1 0/80 (0.00%)  0
EYE PAIN   1/80 (1.25%)  1 0/80 (0.00%)  0
POST PROCEDURE TENDERNESS   0/80 (0.00%)  0 1/80 (1.25%)  1
VISION CHANGES/PROBLEMS   2/80 (2.50%)  2 1/80 (1.25%)  1
Gastrointestinal disorders     
ABDOMINAL DISTENSION   1/80 (1.25%)  1 0/80 (0.00%)  0
ABDOMINAL PAIN   1/80 (1.25%)  1 2/80 (2.50%)  2
ABDOMINAL SWELLING   1/80 (1.25%)  1 0/80 (0.00%)  0
BLOATING   3/80 (3.75%)  3 2/80 (2.50%)  2
BOWEL ISSUES   1/80 (1.25%)  1 11/80 (13.75%)  11
C.DIFFICELE COLITIS   1/80 (1.25%)  1 0/80 (0.00%)  0
CHANGE IN BOWEL MOVEMENTS   1/80 (1.25%)  1 0/80 (0.00%)  0
CONSTIPATION   19/80 (23.75%)  19 13/80 (16.25%)  13
CONSTIPATION AND OBSTIPATION   1/80 (1.25%)  1 0/80 (0.00%)  0
CRAMPING   1/80 (1.25%)  1 0/80 (0.00%)  0
DIARRHEA AND CONSTIPATION (ALTERNATING)   0/80 (0.00%)  0 2/80 (2.50%)  2
DIARRHEA/LOOSE STOOL   4/80 (5.00%)  5 1/80 (1.25%)  1
DIARRHEA-C.DIFF   0/80 (0.00%)  0 1/80 (1.25%)  1
DISCOLORED FECES   1/80 (1.25%)  1 0/80 (0.00%)  0
DYSPHAGIA   1/80 (1.25%)  1 0/80 (0.00%)  0
ELEVATED LIVER FUNCTION TESTS   2/80 (2.50%)  2 0/80 (0.00%)  0
EMESIS AND/OR NAUSEA   17/80 (21.25%)  17 22/80 (27.50%)  22
FECAL INCONTINENCE   1/80 (1.25%)  1 0/80 (0.00%)  0
FECAL URGENCY   1/80 (1.25%)  1 0/80 (0.00%)  0
GAS PAIN   1/80 (1.25%)  1 1/80 (1.25%)  1
GAS RETENTION   2/80 (2.50%)  2 1/80 (1.25%)  1
GASTROENTERITIS   2/80 (2.50%)  2 7/80 (8.75%)  7
GERD   0/80 (0.00%)  0 3/80 (3.75%)  3
GI BACTERIAL OVERGROWTH   0/80 (0.00%)  0 1/80 (1.25%)  1
GI ISSUES RELATED TO IBS   2/80 (2.50%)  2 0/80 (0.00%)  0
HEARTBURN   1/80 (1.25%)  1 0/80 (0.00%)  0
HEMORRHOIDS   2/80 (2.50%)  2 1/80 (1.25%)  1
HERNIA   0/80 (0.00%)  0 1/80 (1.25%)  1
LOOSE STOOLS AND LEAKAGE   0/80 (0.00%)  0 1/80 (1.25%)  1
MEDICATION INTOLERANCE   1/80 (1.25%)  1 1/80 (1.25%)  1
NAUSEA AND APPETITE CHANGES   0/80 (0.00%)  0 1/80 (1.25%)  1
NAUSEA AND DIARRHEA   1/80 (1.25%)  1 0/80 (0.00%)  0
RBS   0/80 (0.00%)  0 1/80 (1.25%)  1
RECTAL HEMORRHAGE   1/80 (1.25%)  1 0/80 (0.00%)  0
General disorders     
ABDOMINAL TENDERNESS   0/80 (0.00%)  0 1/80 (1.25%)  1
ABDOMINAL TINGLING   0/80 (0.00%)  0 1/80 (1.25%)  1
ALLERGY   1/80 (1.25%)  1 0/80 (0.00%)  0
APPETITE CHANGES   0/80 (0.00%)  0 1/80 (1.25%)  1
BLADDER PERFORATION INTRA-OPERATIVELY   0/80 (0.00%)  0 1/80 (1.25%)  1
BLEEDING   1/80 (1.25%)  1 0/80 (0.00%)  0
BOWEL DISCOMFORT   0/80 (0.00%)  0 1/80 (1.25%)  1
BUG BITE   1/80 (1.25%)  1 0/80 (0.00%)  0
BUTTOCKPAIN/LABIAL BURN   1/80 (1.25%)  1 0/80 (0.00%)  0
CHILLS   0/80 (0.00%)  0 2/80 (2.50%)  2
CHILLS, VASOMOTOR SYMPTOMS   0/80 (0.00%)  0 1/80 (1.25%)  1
CHRONIC ENDOMETRITIS   1/80 (1.25%)  1 0/80 (0.00%)  0
DIAGNOSIS OF METASTASIS OF COLON CANCER   1/80 (1.25%)  1 0/80 (0.00%)  0
DIFFICULT VOIDING DUE TO SWELLING   1/80 (1.25%)  1 0/80 (0.00%)  0
DIZZINESS   0/80 (0.00%)  0 1/80 (1.25%)  1
EXTENDED UVULAR/UVULAR IRRITATION   0/80 (0.00%)  0 1/80 (1.25%)  1
FATIGUE AND DISCOMFORT WITH MOVEMENT   0/80 (0.00%)  0 1/80 (1.25%)  1
FATIGUE OR DECREASED ENERGY LEVEL   3/80 (3.75%)  3 3/80 (3.75%)  3
FEVER   0/80 (0.00%)  0 2/80 (2.50%)  2
HEMATOMA   0/80 (0.00%)  0 1/80 (1.25%)  1
INCISION PAIN   0/80 (0.00%)  0 1/80 (1.25%)  1
INCISION SEEPAGE   0/80 (0.00%)  0 1/80 (1.25%)  1
LOW VITAMIN D LEVEL   1/80 (1.25%)  1 0/80 (0.00%)  0
MALAISE   0/80 (0.00%)  0 1/80 (1.25%)  1
MIGRAINE   1/80 (1.25%)  1 0/80 (0.00%)  0
OSTEOPENIA   0/80 (0.00%)  0 1/80 (1.25%)  1
PAIN - POST OPERATIVE   1/80 (1.25%)  1 2/80 (2.50%)  2
PAIN - PUBIC   0/80 (0.00%)  0 1/80 (1.25%)  1
PAIN BY LEFT HIP   1/80 (1.25%)  1 0/80 (0.00%)  0
PAIN IN LOWER BACK   1/80 (1.25%)  1 0/80 (0.00%)  0
PAIN IN RIGHT LEG   0/80 (0.00%)  0 1/80 (1.25%)  1
PANCREATIC MASS   0/80 (0.00%)  0 1/80 (1.25%)  1
POST OP PAIN VERSUS NEUROLOGIC/ NEUROPATHIC PAIN   1/80 (1.25%)  1 0/80 (0.00%)  0
TEETH PAIN   1/80 (1.25%)  1 0/80 (0.00%)  0
URINARY RETENTION   0/80 (0.00%)  0 1/80 (1.25%)  1
VAGINAL BLEEDING   3/80 (3.75%)  3 0/80 (0.00%)  0
VAGINAL DISCHARGE   0/80 (0.00%)  0 1/80 (1.25%)  1
VAGINAL DISCOMFORT   0/80 (0.00%)  0 1/80 (1.25%)  1
VULVAR PRURITIS   0/80 (0.00%)  0 1/80 (1.25%)  1
WEIGHT GAIN   1/80 (1.25%)  1 0/80 (0.00%)  0
WEIGHT LOSS DUE TO LOSS OF APPETITE   0/80 (0.00%)  0 1/80 (1.25%)  1
Immune system disorders     
COMMON COLD   0/80 (0.00%)  0 1/80 (1.25%)  1
LOW GRADE FEVER   1/80 (1.25%)  1 0/80 (0.00%)  0
SINUS ISSUES   0/80 (0.00%)  0 1/80 (1.25%)  1
Infections and infestations     
BODY SUBSTANCE EXPOSURE   0/80 (0.00%)  0 2/80 (2.50%)  2
CHILLS   0/80 (0.00%)  0 1/80 (1.25%)  1
COLD SYMPTOMS   1/80 (1.25%)  1 0/80 (0.00%)  0
ELEVATED WBL   0/80 (0.00%)  0 1/80 (1.25%)  1
INFECTION OF INCISION SITE (ONE SPECIFIED ERYTHEMA)   0/80 (0.00%)  0 1/80 (1.25%)  2
ONCHOLISIS   1/80 (1.25%)  1 0/80 (0.00%)  0
SINUS PROBLEMS   1/80 (1.25%)  1 0/80 (0.00%)  0
TOOTH ABSCESS   1/80 (1.25%)  1 0/80 (0.00%)  0
VIRAL SYNDRONE   1/80 (1.25%)  1 0/80 (0.00%)  0
YEAST VAGINITIS   5/80 (6.25%)  5 2/80 (2.50%)  2
Injury, poisoning and procedural complications     
CYSTOTOMY   1/80 (1.25%)  1 0/80 (0.00%)  0
FALL   0/80 (0.00%)  0 1/80 (1.25%)  1
Investigations     
ABNORMAL LABS   0/80 (0.00%)  0 1/80 (1.25%)  1
Metabolism and nutrition disorders     
DIFFICULTY EATING AND DRINKING/APPETITE CHANGES   0/80 (0.00%)  0 2/80 (2.50%)  2
Musculoskeletal and connective tissue disorders     
ABDOMINAL PAIN/PRESSURE   4/80 (5.00%)  5 10/80 (12.50%)  10
ACHY   2/80 (2.50%)  2 1/80 (1.25%)  1
BACK PAIN   2/80 (2.50%)  2 4/80 (5.00%)  4
BILATERAL KNEE PAIN   0/80 (0.00%)  0 1/80 (1.25%)  1
BONE PAIN   0/80 (0.00%)  0 1/80 (1.25%)  1
BRUISING   0/80 (0.00%)  0 2/80 (2.50%)  2
BUTTOCK/HIP PAIN   4/80 (5.00%)  4 7/80 (8.75%)  7
CHEST PAIN   0/80 (0.00%)  0 1/80 (1.25%)  1
CRAMPING   0/80 (0.00%)  0 4/80 (5.00%)  4
HEADACHE   0/80 (0.00%)  0 1/80 (1.25%)  1
HIP FRACTURE (R GREATER TROCHOUTER AVULSION FRACTURE)   0/80 (0.00%)  0 1/80 (1.25%)  1
INCISION PAIN   0/80 (0.00%)  0 4/80 (5.00%)  4
JAW NUMBNESS   0/80 (0.00%)  0 1/80 (1.25%)  1
LOWER BACK PACK   1/80 (1.25%)  1 6/80 (7.50%)  6
LOWER QUADRANT DISCOMFORT   1/80 (1.25%)  1 0/80 (0.00%)  0
LUMP IN LOWER ABDOMIN   1/80 (1.25%)  1 0/80 (0.00%)  0
MILD CARPAL TUNNEL SYNDROME ON RIGHT   0/80 (0.00%)  0 1/80 (1.25%)  1
MUSCULOSKELETAL PAIN DUE TO TRAUMA   0/80 (0.00%)  0 1/80 (1.25%)  1
PAIN FORM DILATOR   1/80 (1.25%)  1 0/80 (0.00%)  0
PAIN ON RIGHT SIDE   1/80 (1.25%)  1 0/80 (0.00%)  0
PAIN WITH ACTIVITY   1/80 (1.25%)  1 0/80 (0.00%)  0
PAIN/PRESSURE/SORENESS   18/80 (22.50%)  19 16/80 (20.00%)  17
PATELLOFEMORAL DEGENERATIVE JOINT DISEASE AND DEGENERATIVE TEAR POSTERIOR TORN LATERAL MENISCUS   0/80 (0.00%)  0 1/80 (1.25%)  1
POST OPERATIVE REPAIR   0/80 (0.00%)  0 1/80 (1.25%)  1
PRESSURE ON LEFT SIDE   1/80 (1.25%)  1 0/80 (0.00%)  0
RECTAL DISCOMFORT   0/80 (0.00%)  0 2/80 (2.50%)  2
RECTAL INDURATION   1/80 (1.25%)  1 0/80 (0.00%)  0
SHOULDER PAIN   1/80 (1.25%)  1 0/80 (0.00%)  0
SUPRAPUBIC/PUBIC PAIN   3/80 (3.75%)  3 5/80 (6.25%)  5
TENDONITIS   1/80 (1.25%)  1 0/80 (0.00%)  0
UPPER BACK/NECK/SHOULDER PAIN   0/80 (0.00%)  0 6/80 (7.50%)  6
VAGINAL AND URETHRAL PAIN   1/80 (1.25%)  1 0/80 (0.00%)  0
WEAKNESS   2/80 (2.50%)  2 1/80 (1.25%)  1
Nervous system disorders     
DIZZINESS AND RINGING IN EARS   0/80 (0.00%)  0 1/80 (1.25%)  1
DIZZINESS/VERTIGO   3/80 (3.75%)  3 2/80 (2.50%)  2
FALL   0/80 (0.00%)  0 1/80 (1.25%)  1
FATIGUE   0/80 (0.00%)  0 1/80 (1.25%)  1
HEADACHE   6/80 (7.50%)  6 5/80 (6.25%)  5
LATERAL FEMORAL CUTANEOUS NERVE INJURY   0/80 (0.00%)  0 1/80 (1.25%)  1
LEFT NEUROPATHY DUE TO SURGICAL POSITIONING AND LENGTH OF CARE   1/80 (1.25%)  1 0/80 (0.00%)  0
LEG NUMBNESS   1/80 (1.25%)  1 0/80 (0.00%)  0
LIGHTHEADEDNESS   3/80 (3.75%)  3 2/80 (2.50%)  2
MEMORY ISSUES   2/80 (2.50%)  2 0/80 (0.00%)  0
MIGRAINES   2/80 (2.50%)  2 0/80 (0.00%)  0
NEUROLOGIC PARENTHESES   1/80 (1.25%)  1 0/80 (0.00%)  0
POST OPERATIVE PARESTHESIS   0/80 (0.00%)  0 1/80 (1.25%)  1
PUDENDAL NEUROPATHY   1/80 (1.25%)  1 0/80 (0.00%)  0
SLEEP APNEA-NEW DIAGNOSIS   1/80 (1.25%)  1 0/80 (0.00%)  0
SLEEP DIFFICULTIES   0/80 (0.00%)  0 2/80 (2.50%)  3
VAGAL REACTION   0/80 (0.00%)  0 1/80 (1.25%)  1
Psychiatric disorders     
ANXIETY   0/80 (0.00%)  0 1/80 (1.25%)  1
MENTAL STATUS CHANGES   1/80 (1.25%)  1 0/80 (0.00%)  0
MOOD DISTURBANCE   1/80 (1.25%)  1 0/80 (0.00%)  0
STRESS INDUCED FATIGUE   0/80 (0.00%)  0 1/80 (1.25%)  1
Renal and urinary disorders     
ANION GAP METABOLIC ACIDOSIS WITH CONCOMITANT METABOLIC ALKALOSIS   0/80 (0.00%)  0 1/80 (1.25%)  1
BLADDER ERYTHEMA   1/80 (1.25%)  1 0/80 (0.00%)  0
BLADDER SPASMS   3/80 (3.75%)  3 4/80 (5.00%)  4
CATHETER DISCOMFORT   1/80 (1.25%)  1 1/80 (1.25%)  1
ELEVATED CREATININE LEVEL   0/80 (0.00%)  0 1/80 (1.25%)  1
HEMATURIA   3/80 (3.75%)  3 1/80 (1.25%)  1
PAIN   0/80 (0.00%)  0 1/80 (1.25%)  1
POST OPERATIVE HEALING   0/80 (0.00%)  0 1/80 (1.25%)  1
RENAL INSUFFICIENCY   0/80 (0.00%)  0 1/80 (1.25%)  1
URETHRAL PAIN   0/80 (0.00%)  0 2/80 (2.50%)  2
URINARY FREQUENCY   3/80 (3.75%)  3 0/80 (0.00%)  0
URINARY URGENCY AND FREQUENCY   1/80 (1.25%)  1 0/80 (0.00%)  0
URINARY INCONTINENCE   5/80 (6.25%)  5 6/80 (7.50%)  6
URINARY ISSUES   14/80 (17.50%)  14 22/80 (27.50%)  23
URINARY RETENTION   12/80 (15.00%)  12 14/80 (17.50%)  16
UTI Symptoms   0/80 (0.00%)  0 3/80 (3.75%)  4
VAGINAL BLEEDING   0/80 (0.00%)  0 1/80 (1.25%)  1
Reproductive system and breast disorders     
ABNORMAL ULTRASOUND RESULTS -THICKENED ENDOMETRIAL STRIPE   0/80 (0.00%)  0 1/80 (1.25%)  1
CRAMPING WITH MINSES   1/80 (1.25%)  1 0/80 (0.00%)  0
DYSPAREUNIA   0/80 (0.00%)  0 1/80 (1.25%)  1
ENLARGED UTERUS   1/80 (1.25%)  1 0/80 (0.00%)  0
FEELING OF FULLNESS   0/80 (0.00%)  0 1/80 (1.25%)  1
INCREASED DISCOMFORT DURING MENSES   0/80 (0.00%)  0 1/80 (1.25%)  1
LABIAL EDEMA   0/80 (0.00%)  0 1/80 (1.25%)  1
MENOPAUSAL SYMPTOMS   0/80 (0.00%)  0 1/80 (1.25%)  1
PAIN WITH INTERMITTENT SELF CATH   0/80 (0.00%)  0 1/80 (1.25%)  1
PELVIC PAIN V. POST OP DISCONFORT   1/80 (1.25%)  1 0/80 (0.00%)  0
PERINAEAL PAIN IN THE INTROITAL REGION   0/80 (0.00%)  0 1/80 (1.25%)  1
PERINEAL DESCENT   0/80 (0.00%)  0 1/80 (1.25%)  1
SWELLING/IRRITION   0/80 (0.00%)  0 1/80 (1.25%)  1
URINARY FREQUENCY   0/80 (0.00%)  0 1/80 (1.25%)  1
URINARY LEAKAGE   1/80 (1.25%)  1 0/80 (0.00%)  0
VAGINAL BLEEDING   13/80 (16.25%)  13 16/80 (20.00%)  16
VAGINAL CHANGES   3/80 (3.75%)  3 0/80 (0.00%)  0
VAGINAL DISCHARGE   6/80 (7.50%)  6 6/80 (7.50%)  6
VAGINAL INFECTION   0/80 (0.00%)  0 4/80 (5.00%)  4
VAGINAL IRRITATION   1/80 (1.25%)  1 0/80 (0.00%)  0
VAGINAL PAN/PRESSURE   2/80 (2.50%)  2 1/80 (1.25%)  1
VULVAR PRURITUS   1/80 (1.25%)  1 0/80 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ABNORMAL CHEST EXAM   0/80 (0.00%)  0 1/80 (1.25%)  1
AIRWAY ISSUES   1/80 (1.25%)  1 1/80 (1.25%)  1
BRONCHITIS   2/80 (2.50%)  2 1/80 (1.25%)  1
COUGHING EPISODES   1/80 (1.25%)  1 0/80 (0.00%)  0
DESATURATION   0/80 (0.00%)  0 1/80 (1.25%)  1
LUNG ISSUES   1/80 (1.25%)  1 0/80 (0.00%)  0
MILD COUGH   0/80 (0.00%)  0 1/80 (1.25%)  1
OBSTRUCTIVE SLEEP APNEA   0/80 (0.00%)  0 1/80 (1.25%)  1
PERSISTENT COUGH   0/80 (0.00%)  0 1/80 (1.25%)  1
PNEUMONIA   0/80 (0.00%)  0 1/80 (1.25%)  1
POSTNASAL DRIP AND NASAL OBSTRUCTION   0/80 (0.00%)  0 1/80 (1.25%)  1
SHORTNESS OF BREATH   4/80 (5.00%)  4 2/80 (2.50%)  2
SINUS SYMPTOMS   2/80 (2.50%)  2 2/80 (2.50%)  2
SORE THROAT   1/80 (1.25%)  1 2/80 (2.50%)  2
UPPER RESPIRATORY INFECTION   1/80 (1.25%)  1 2/80 (2.50%)  2
Skin and subcutaneous tissue disorders     
ABDOMINAL SENSITIVITY   0/80 (0.00%)  0 1/80 (1.25%)  1
AGGLUTINATION BETWEEN ANTERIOR AND POSTERIOR WALLS   0/80 (0.00%)  0 1/80 (1.25%)  1
AIR POCKET UNDER SKIN   0/80 (0.00%)  0 1/80 (1.25%)  1
BENIGN LESION   1/80 (1.25%)  1 0/80 (0.00%)  0
BRUISE   0/80 (0.00%)  0 2/80 (2.50%)  2
BRUISING   1/80 (1.25%)  1 0/80 (0.00%)  0
HAIR LOSS   4/80 (5.00%)  5 1/80 (1.25%)  1
HERPES ZOSTER   0/80 (0.00%)  0 1/80 (1.25%)  1
INCISION ISSUES   1/80 (1.25%)  1 2/80 (2.50%)  2
KELOID   1/80 (1.25%)  1 0/80 (0.00%)  0
LICHENS SCLEROSIS FLARE   1/80 (1.25%)  1 0/80 (0.00%)  0
NAIL CHANGES   1/80 (1.25%)  1 0/80 (0.00%)  0
PRURITIS   1/80 (1.25%)  1 3/80 (3.75%)  3
RASH   3/80 (3.75%)  3 0/80 (0.00%)  0
ROSACEA   0/80 (0.00%)  0 1/80 (1.25%)  1
SKIN NUMBNESS AND TINGLING   0/80 (0.00%)  0 1/80 (1.25%)  1
SORE TEMPLE   1/80 (1.25%)  1 0/80 (0.00%)  0
TISSUE BULGE   1/80 (1.25%)  1 0/80 (0.00%)  0
WOUND INFECTION   0/80 (0.00%)  0 1/80 (1.25%)  1
YEAST INFECTIONS   0/80 (0.00%)  0 2/80 (2.50%)  2
Social circumstances     
EMOTIONAL STRESS   1/80 (1.25%)  1 0/80 (0.00%)  0
Surgical and medical procedures     
ABDOMINAL PAIN POST OP   1/80 (1.25%)  1 2/80 (2.50%)  2
BOTHERSOME STITICHES   0/80 (0.00%)  0 1/80 (1.25%)  1
DENTAL EXTRACTION   0/80 (0.00%)  0 1/80 (1.25%)  1
EXTENSIVE ADHESIVE DISEASE   1/80 (1.25%)  1 0/80 (0.00%)  0
FATIGUE   0/80 (0.00%)  0 1/80 (1.25%)  1
GRANULATION   0/80 (0.00%)  0 1/80 (1.25%)  1
HEALING WOUND   0/80 (0.00%)  0 1/80 (1.25%)  1
HEMATOMA   0/80 (0.00%)  0 1/80 (1.25%)  1
INCISIONAL PAIN   2/80 (2.50%)  2 0/80 (0.00%)  0
PAIN/DISCOMFORT   4/80 (5.00%)  6 6/80 (7.50%)  6
POST OP SWELLING   1/80 (1.25%)  1 0/80 (0.00%)  0
POST SITE HERNIA   1/80 (1.25%)  1 0/80 (0.00%)  0
POSTOPERATIVE DIFFICULTIES   0/80 (0.00%)  0 2/80 (2.50%)  2
RIGHT BUTTOCK PAIN DUE TO SURGICAL PROCEDURE   0/80 (0.00%)  0 1/80 (1.25%)  1
SLING REVISION AND WOUND EXPLORATION SURGERY   0/80 (0.00%)  0 1/80 (1.25%)  1
SORE SPOT/SUTURE DISCOMFORT   0/80 (0.00%)  0 1/80 (1.25%)  1
SWELLING   1/80 (1.25%)  1 0/80 (0.00%)  0
VAGINAL BLEEDING POST OPERATIVELY   1/80 (1.25%)  1 2/80 (2.50%)  2
Vascular disorders     
CHRONIC HYPERTENSION   1/80 (1.25%)  1 0/80 (0.00%)  0
DILATED TORTUOUS VESSELS IN THE RIGHT RETROPUBIC SPACE   1/80 (1.25%)  1 0/80 (0.00%)  0
HYPERTENSION   1/80 (1.25%)  1 0/80 (0.00%)  0
HYPOTENSION   1/80 (1.25%)  1 0/80 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Betsy Foxman, Hunein F. and Hilda Maassab Professor of Epidemiology
Organization: University of Michigan
Phone: 734-764-5487
Responsible Party: Betsy Foxman, University of Michigan
ClinicalTrials.gov Identifier: NCT01346774     History of Changes
Other Study ID Numbers: R21DK085290 ( U.S. NIH Grant/Contract )
HUM00041108 ( Other Identifier: University of Michigan IRBMED )
R21DK085290 ( U.S. NIH Grant/Contract )
First Submitted: April 29, 2011
First Posted: May 3, 2011
Results First Submitted: April 28, 2015
Results First Posted: June 10, 2015
Last Update Posted: June 10, 2015