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

NCT01450800 | Completed Phase 4 Results DMC

• 2 other identifiers: Pro000252693913577
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infection

Keywords

urinary tract infection; gynecologic surgery; post-operative complications; nitrofurantoin

Outcome Measures

Primary Outcomes (1)

• Urinary Tract Infections

  The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.

  three weeks post-operative

Secondary Outcomes (7)

• Other Risk Factors for UTI

  3 weeks following surgery

• Other Risk Factors for UTI

  3 weeks following surgery

• Other Risk Factors for UTI

  3 weeks following surgery

• Other Risk Factors for UTI

  3 weeks following surgery

• Other Risk Factors for UTI

  3 weeks following surgery

Other Outcomes (1)

• Antibiotic Resistance to Macrobid

  6 weeks after surgery

Study Arms (2)

Nitrofurantoin

ACTIVE COMPARATOR

Nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization

Drug: Nitrofurantoin

Placebo

PLACEBO COMPARATOR

Placebo drug 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization

Drug: Placebo

Interventions

Nitrofurantoin DRUG

Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively

Also known as: Macrobid, Macrodantin

Nitrofurantoin

Placebo DRUG

Participants randomized to placebo will be instructed to take placebo one tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization

Also known as: Placebo medication, Inactive medication

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing urogynecologic surgery
• Receive postoperative catheterization

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (11)

• 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. doi: 10.1016/s0029-7844(99)00263-x.

  PMID: 10389720 BACKGROUND

• Hannestad YS, Rortveit G, Sandvik H, Hunskaar S; Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol. 2000 Nov;53(11):1150-7. doi: 10.1016/s0895-4356(00)00232-8.

  PMID: 11106889 BACKGROUND

• 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. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.

  PMID: 17049716 BACKGROUND

• Thomas TM, Plymat KR, Blannin J, Meade TW. Prevalence of urinary incontinence. Br Med J. 1980 Nov 8;281(6250):1243-5. doi: 10.1136/bmj.281.6250.1243.

  PMID: 7427654 BACKGROUND

• 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):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.

  PMID: 19935030 BACKGROUND

• 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. doi: 10.1002/nau.10164.

  PMID: 14694449 BACKGROUND

• 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. doi: 10.1007/s001920170003.

  PMID: 11450979 BACKGROUND

• 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. doi: 10.1007/s00192-008-0584-0. Epub 2008 Apr 10.

  PMID: 18401538 BACKGROUND

• 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. doi: 10.1007/s00192-009-0885-y. Epub 2009 Apr 10.

  PMID: 19582384 BACKGROUND

• 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. doi: 10.1016/j.amjmed.2009.01.034.

  PMID: 19635279 BACKGROUND

• Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.

  PMID: 24463669 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Limitations of our study include recall bias and selection bias. Our findings have limited applicability to elderly patients undergoing pelvic reconstructive surgery.

Results Point of Contact

• Title: Dr. Alexis Dieter
• Organization: Duke University Medical Center

alexis.dieter@duke.edu

919-401-1006

Study Officials

• Cindy Amundsen, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 12, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 13, 2017
• Results First Posted: May 1, 2014

Record last verified: 2016-12

Locations

US (1)