Trial Outcomes & Findings for Preventing Urinary Tract Infection Post-Surgery (NCT NCT01346774)

Last Updated: 2015-06-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

From surgery to post-op visit, approximately 6 weeks post surgery

Results posted on

2015-06-10

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Cranberry Capsules Cranberry powder: 2 cranberry powder capsules twice a day	Placebo Placebo powder: 2 placebo powder capsules twice a day
Overall Study STARTED	80	80
Overall Study COMPLETED	67	63
Overall Study NOT COMPLETED	13	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Cranberry Capsules Cranberry powder: 2 cranberry powder capsules twice a day	Placebo Placebo powder: 2 placebo powder capsules twice a day
Overall Study Did not take a single dose	6	4
Overall Study Lost to Follow-up	3	4
Overall Study Withdrawal by Subject	1	4
Overall Study Protocol Violation	2	3
Overall Study Adverse Event	1	2

Baseline Characteristics

Preventing Urinary Tract Infection Post-Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cranberry Capsules n=80 Participants Cranberry powder: 2 cranberry powder capsules twice a day	Placebo n=80 Participants Placebo powder: 2 placebo powder capsules twice a day	Total n=160 Participants Total of all reporting groups
Age, Customized 18 - 60 years	47 participants n=5 Participants	48 participants n=7 Participants	95 participants n=5 Participants
Age, Customized > 60 years	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	80 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants	77 Participants n=7 Participants	152 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	72 Participants n=7 Participants	141 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	80 participants n=7 Participants	160 participants n=5 Participants
Experienced a UTI in the past 12 mo	18 participants n=5 Participants	19 participants n=7 Participants	37 participants n=5 Participants
Ever experienced UTI in life	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants
Reasons for surgery Fibroids	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Reasons for surgery Pelvic organ prolapse	51 participants n=5 Participants	56 participants n=7 Participants	107 participants n=5 Participants
Reasons for surgery Stress urinary incontinence	21 participants n=5 Participants	23 participants n=7 Participants	44 participants n=5 Participants
Reasons for surgery Chronic pelvic pain	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Reasons for surgery Endometriosis	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Reasons for surgery Abnormal uterine bleeding	11 participants n=5 Participants	6 participants n=7 Participants	17 participants n=5 Participants
Reasons for surgery Adnexal mass	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Reasons for surgery Other	9 participants n=5 Participants	18 participants n=7 Participants	27 participants n=5 Participants
Type of Surgery Urinary incontinence operation	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Type of Surgery Prolapse/reconstructive	52 participants n=5 Participants	58 participants n=7 Participants	110 participants n=5 Participants
Type of Surgery Hysterectomy/other extirpative	35 participants n=5 Participants	42 participants n=7 Participants	77 participants n=5 Participants
Type of Surgery Other	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cranberry Capsules n=80 Participants Cranberry powder: 2 cranberry powder capsules twice a day	Placebo n=80 Participants Placebo powder: 2 placebo powder capsules twice a day
Participants With Clinically-diagnosed and Treated UTI's.	15 participants Interval 11.71 to 28.66	30 participants Interval 27.69 to 48.45

Adverse Events

Cranberry Capsules

Serious events: 4 serious events

Other events: 75 other events

Deaths: 0 deaths

Placebo Capsules

Serious events: 4 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cranberry Capsules n=80 participants at risk Cranberry powder: 2 cranberry powder capsules twice a day	Placebo Capsules n=80 participants at risk Placebo powder: 2 placebo powder capsules twice a day
Gastrointestinal disorders Incarcerated hernia, small bowel obstruction	0.00% 0/80 • 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 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.	1.2% 1/80 • Number of events 1 • 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 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.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolus in Right Lower Lobe	0.00% 0/80 • 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 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.	1.2% 1/80 • Number of events 1 • 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 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/80 • 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 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.	1.2% 1/80 • Number of events 1 • 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 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.
Renal and urinary disorders UTI	0.00% 0/80 • 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 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.	1.2% 1/80 • Number of events 1 • 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 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.
Gastrointestinal disorders Chest pain secondary to reflux (GERD)	1.2% 1/80 • Number of events 1 • 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 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.	0.00% 0/80 • 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 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.
Musculoskeletal and connective tissue disorders Right hip fracture	0.00% 0/80 • 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 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.	1.2% 1/80 • Number of events 1 • 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 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.
Musculoskeletal and connective tissue disorders Vertebral compression fracture	0.00% 0/80 • 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 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.	1.2% 1/80 • Number of events 1 • 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 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.
Blood and lymphatic system disorders Altered mental status and progressive fatigue due to chronic anemia	0.00% 0/80 • 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 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.	1.2% 1/80 • Number of events 1 • 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 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.
Respiratory, thoracic and mediastinal disorders Transfusion related acute lung injury versus post operative pneumonia	1.2% 1/80 • Number of events 1 • 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 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.	0.00% 0/80 • 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 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.
Renal and urinary disorders Renal failure	1.2% 1/80 • Number of events 1 • 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 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.	0.00% 0/80 • 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 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 1/80 • Number of events 1 • 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 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.	0.00% 0/80 • 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 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.
Nervous system disorders Atypical migraine	1.2% 1/80 • Number of events 1 • 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 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.	0.00% 0/80 • 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 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.

Other adverse events

Additional Information

Betsy Foxman, Hunein F. and Hilda Maassab Professor of Epidemiology

University of Michigan

Phone: 734-764-5487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place