PRECAUTION: Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01108757
• Collaborator: American Urogynecologic Society (Other)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.

Condition or Disease	Intervention/Treatment	Phase
Catheter-Associated Urinary Tract Infection	Drug: Bactrim; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drug	Drug: Bactrim; Bactrim DS BID for 3 days
Placebo Comparator: Placebo	Other: Placebo; Corn starch capsules

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Urinary Tract Infection [7 days following catheter removal]

   Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Requires catheterization >24h hours following incontinence or pelvic reconstructive surgery

Exclusion Criteria:

• Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization

• Allergy to sulfonamides or trimethoprim

• Non-English speaking

• Pregnancy

• Breast feeding

• Severe renal impairment (creatinine clearance <30)

• Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• American Urogynecologic Society

Investigators

• Principal Investigator: Matthew D Barber, MD MHS, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01108757
• Other Study ID Numbers: 10-125
• First Posted: Apr 22, 2010
• Last Update Posted: Oct 18, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by The Cleveland Clinic: catheter; urinary tract infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Trimethoprim, Sulfamethoxazole Drug Combination

Study Results

Participant Flow

Recruitment Details	A total of 52 subjects were recruited.

Arm/Group Title	Drug	Placebo
Arm/Group Description	Bactrim: Bactrim DS BID for 3 days	Placebo: Corn starch capsules
Period Title: Overall Study
STARTED	26	26
COMPLETED	26	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Drug	Placebo	Total
Arm/Group Description	Bactrim: Bactrim DS BID for 3 days Demographics data by group not available as this study was discontinued in 2013. Currently randomization data not available for reassessment.	Placebo: Corn starch capsules	Total of all reporting groups
Overall Participants	26	26	52
Age, Customized (years) [Mean (Standard Deviation) ]
Mean Age	60 (12.9)	58 (13.0)	59 (12.9)
Sex: Female, Male (Count of Participants)
Female	26 100%	26 100%	52 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	26 100%	26 100%	52 100%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.8 (2.7)	27.2 (4.3)	26.5 (3.5)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Urinary Tract Infection
Description	Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL
Time Frame	7 days following catheter removal

Outcome Measure Data

Analysis Population Description

Study terminated early.

Arm/Group Title	Drug	Placebo
Arm/Group Description	Bactrim: Bactrim DS BID for 3 days	Placebo: Corn starch capsules
Measure Participants	26	26
Count of Participants [Participants]	6 23.1%	6 23.1%

Adverse Events

Time Frame	3-years while patients were in treatment and follow-up
Arm/Group Title	Drug		Placebo
Arm/Group Description	Bactrim: Bactrim DS BID for 3 days		Placebo: Corn starch capsules
All Cause Mortality
	Drug		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Serious Adverse Events
	Drug		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Drug		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.