Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) - Full Text View

Purpose

This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.

Condition	Intervention	Phase
Urinary Tract Infection	Drug: Nitrofurantoin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Urinary Tract Infections

Drug Information available for: Nitrofurantoin sodium Nitrofurantoin Nitrofurantoin monohydrate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Urinary tract infection [ Time Frame: three weeks post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other Risk Factors for UTI [ Time Frame: 3 weeks following surgery ] [ Designated as safety issue: No ]
We will examine risk of UTI as related to vaginal estrogen therapy, history of recurrent UTIs, preoperative PVR, preoperative UTI treatment, Creatinine Clearance, sling as part of surgery, postoperative void trial PVR, total postoperative catheter days, postoperative catheter type, total days of use of study drug

Other Outcome Measures:

Antibiotic resistance to macrobid [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
Examine for macrobid resistance on urine culture results within 6 weeks of surgery

Enrollment:	159
Study Start Date:	August 2011
Estimated Study Completion Date:	January 2014
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Nitrofurantoin	Drug: Nitrofurantoin Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively Other Name: Macrobid, Macrodantin
Placebo Comparator: Placebo	Drug: Nitrofurantoin Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively Other Name: Macrobid, Macrodantin

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Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Undergoing urogynecologic surgery
Receive postoperative catheterization

Exclusion Criteria:

Age less than 21 years old
Pregnancy
Allergy, contraindication or intolerance to Nitrofurantoin
Do not speak English
Dependent on trans-urethral catheter to accomplish voiding preoperatively
Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
Sustain intraoperative urinary tract injury requiring postoperative catheterization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450800

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Cindy Amundsen, MD

Duke University

More Information

Publications:

Brown JS, Grady D, Ouslander JG, Herzog AR, Varner RE, Posner SF. Prevalence of urinary incontinence and associated risk factors in postmenopausal women. Heart & Estrogen/Progestin Replacement Study (HERS) Research Group. Obstet Gynecol. 1999 Jul;94(1):66-70.

Hannestad YS, Rortveit G, Sandvik H, Hunskaar S; Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trøndelag. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trøndelag. J Clin Epidemiol. 2000 Nov;53(11):1150-7.

Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. Epub 2006 Oct 2.

Thomas TM, Plymat KR, Blannin J, Meade TW. Prevalence of urinary incontinence. Br Med J. 1980 Nov 8;281(6250):1243-5.

Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-83.

Levin I, Groutz A, Gold R, Pauzner D, Lessing JB, Gordon D. Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients. Neurourol Urodyn. 2004;23(1):7-9.

Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8.

Falagas ME, Athanasiou S, Iavazzo C, Tokas T, Antsaklis A. Urinary tract infections after pelvic floor gynecological surgery: prevalence and effect of antimicrobial prophylaxis. A systematic review. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1165-72. Epub 2008 Apr 10. Review.

Sutkin G, Lowder JL, Smith KJ. Prophylactic antibiotics to prevent urinary tract infection during clean intermittent self-catheterization (CISC) for management of voiding dysfunction after prolapse and incontinence surgery: a decision analysis. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Aug;20(8):933-8. Epub 2009 Apr 10.

Macy E, Poon K-Y T. Self-reported antibiotic allergy incidence and prevalence: age and sex effects. Am J Med. 2009 Aug;122(8):778.e1-7.

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01450800 History of Changes
Other Study ID Numbers:	Pro00025269, 3913577
Study First Received:	October 10, 2011
Last Updated:	April 1, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

urinary tract infection
gynecologic surgery
post-operative complications
nitrofurantoin

Additional relevant MeSH terms:

Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Nitrofurantoin

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 21, 2013

Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) (STOPP UTI)