Short-course Methenamine Hippurate for Prevention of Post-operative UTI

NCT02358993 | Completed Results

• 1 other identifier: 820117
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 4

Brief Summary

The investigators will determine the efficacy of an innovative short regimen of methenamine hippurate on prevention of post-operative UTI in patients requiring short-term catheterization after pelvic reconstructive surgery through a single-blind, randomized controlled trial. Primary outcome will be the rate of symptomatic UTI within 3 weeks of catheter removal. The investigators will study cost-effectiveness, antibiotic resistance profiles, and adverse drug effects. Findings may reduce antibiotic use and nosocomial UTIs.

Conditions

Urinary Tract Infections; Catheter-Related Infections

Keywords

Urinary Tract Infections; Catheter-Related Infections; Pelvic Reconstructive Surgery; Urogynecology; Urinary catheterization; Post-operative Infections; Methenamine hippurate

Outcome Measures

Primary Outcomes (2)

• Treatment of Clinically Suspected UTI - Using Intent to Treat Analysis

  This is defined as any symptomatic UTI requiring treatment with antibiotics as determined by the development of 2 or more of the following symptoms, in the absence of vaginal symptoms: urinary frequency; urinary urgency; dysuria; fever over 38oC/100.4oF; suprapubic, flank, or back pain; and/or chills.

  3 weeks post-operative

• Treatment of Clinically Suspected UTI - Per Protocol

  This is defined as any symptomatic UTI requiring treatment with antibiotics as determined by the development of 2 or more of the following symptoms, in the absence of vaginal symptoms: urinary frequency; urinary urgency; dysuria; fever over 38oC/100.4oF; suprapubic, flank, or back pain; and/or chills.

  3 weeks post-operative

Secondary Outcomes (4)

• Number of Participants With Culture-positive Symptomatic UTI

  3 weeks post-operative

• Antibiotic Resistance of Culture-positive Symptomatic UTI

  3 weeks post-operative

• Cost-effectiveness of Prophylaxis With Methenamine Hippurate for Prevention of Post-operative UTI Compared to Prophylaxis With Fluoroquinolones

  3 weeks post-operative

• Prevalence of Side Effects

  within 24 hours of administration

Other Outcomes (1)

• Rate of UTI Consistent With NHSN Criteria

  3 weeks post-operative

Study Arms (2)

Methenamine

EXPERIMENTAL

Methenamine hippurate is a medication that exhibits antibacterial activity by converting to formaldehyde in the presence of acidic urine. It is currently FDA approved for the prophylaxis of recurrent urinary tract infections. It has been previously used in studies for prevention of UTI after gynecologic surgery. Dosage will be methenamine hippurate 1g, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.

Drug: methenamine hippurate

Ciprofloxacin

ACTIVE COMPARATOR

Ciprofloxacin is a commonly used antibiotic commonly used for prevention of UTI after catheterization. It belongs to a class of antibiotics known as the fluoroquinolones. Dosage will be ciprofloxacin 500 mg, 1 tablet by mouth every 12 hours for 24 hours (total of two doses), with the first dose taken at least one hour prior to catheter removal.

Drug: Ciprofloxacin

Interventions

methenamine hippurate DRUG

A urinary antiseptic used for prevention of UTI

Also known as: Hiprex

Methenamine

Ciprofloxacin DRUG

An antibiotic used for treatment and prevention of UTI

Also known as: Cipro

Ciprofloxacin

Eligibility Criteria

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

You may qualify if:

• female;
• patients who are able to read and write English;
• years of age or older;
• underwent surgery for pelvic organ prolapse, urinary incontinence, or both;
• require post-operative short-term transurethral catheterization for greater than 24 hours.

You may not qualify if:

• patients undergoing surgical intervention for sacral neuromodulation, or mesh excision;
• patients requiring long-term catheterization secondary to injury to the urinary tract;
• patients who pass their post-operative trial void and thus, do not require additional catheterization;
• patients requiring catheterization for less than 24 hours;
• pregnant patients;
• patients who are breast-feeding;
• allergy to methenamine hippurate or fluroquinolones (either ciprofloxacin or levofloxacin);
• impaired renal or hepatic function;
• pre-operative urinary retention;
• patients who are currently using sulfonamides;
• patients who have severe dehydration;
• patients using tizanidine;
• patients sensitive to quinolones class;
• patients using theophylline; patients with myasthenia gravis;
• patients with prolongation of QT interval.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (4)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Chestnut Hill Hospital

Philadelphia, Pennsylvania, 19118, United States

Location

Related Publications (25)

• Schiotz HA. Comparison of 1 and 3 days' transurethral Foley catheterization after retropubic incontinence surgery. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):98-101. doi: 10.1007/BF01902381.

  PMID: 8798095 BACKGROUND

• Schiotz HA, Guttu K. Value of urinary prophylaxis with methenamine in gynecologic surgery. Acta Obstet Gynecol Scand. 2002 Aug;81(8):743-6. doi: 10.1080/j.1600-0412.2002.810810.x.

  PMID: 12174159 BACKGROUND

• Anger JT, Litwin MS, Wang Q, Pashos CL, Rodriguez LV. Complications of sling surgery among female Medicare beneficiaries. Obstet Gynecol. 2007 Mar;109(3):707-14. doi: 10.1097/01.AOG.0000255975.24668.f2.

  PMID: 17329524 BACKGROUND

• Hakvoort RA, Elberink R, Vollebregt A, Ploeg T, Emanuel MH. How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? A randomised controlled trial comparing short term versus long term catheterisation after vaginal prolapse surgery. BJOG. 2004 Aug;111(8):828-30. doi: 10.1111/j.1471-0528.2004.00181.x.

  PMID: 15270931 BACKGROUND

• Harding GK, Nicolle LE, Ronald AR, Preiksaitis JK, Forward KR, Low DE, Cheang M. How long should catheter-acquired urinary tract infection in women be treated? A randomized controlled study. Ann Intern Med. 1991 May 1;114(9):713-9. doi: 10.7326/0003-4819-114-9-713.

  PMID: 2012351 BACKGROUND

• Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000 Feb;28(1):68-75. doi: 10.1016/s0196-6553(00)90015-4.

  PMID: 10679141 BACKGROUND

• Warren JW. Catheter-associated urinary tract infections. Infect Dis Clin North Am. 1987 Dec;1(4):823-54.

  PMID: 3333661 BACKGROUND

• Wazait HD, van der Meullen J, Patel HR, Brown CT, Gadgil S, Miller RA, Kelsey MC, Emberton M. Antibiotics on urethral catheter withdrawal: a hit and miss affair. J Hosp Infect. 2004 Dec;58(4):297-302. doi: 10.1016/j.jhin.2004.06.012.

  PMID: 15564006 BACKGROUND

• Wolf JS Jr, Bennett CJ, Dmochowski RR, Hollenbeck BK, Pearle MS, Schaeffer AJ; Urologic Surgery Antimicrobial Prophylaxis Best Practice Policy Panel. Best practice policy statement on urologic surgery antimicrobial prophylaxis. J Urol. 2008 Apr;179(4):1379-90. doi: 10.1016/j.juro.2008.01.068. Epub 2008 Feb 20.

  PMID: 18280509 BACKGROUND

• ACOG practice bulletin No. 104: antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2009 May;113(5):1180-1189. doi: 10.1097/AOG.0b013e3181a6d011. No abstract available.

  PMID: 19384149 BACKGROUND

• Ghezzi F, Serati M, Cromi A, Uccella S, Salvatore S, Bolis P. Prophylactic single-dose prulifloxacin for catheter-associated urinary tract infection after tension-free vaginal tape procedure. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jul;18(7):753-7. doi: 10.1007/s00192-006-0233-4. Epub 2006 Nov 21.

  PMID: 17120175 BACKGROUND

• Rogers RG, Kammerer-Doak D, Olsen A, Thompson PK, Walters MD, Lukacz ES, Qualls C. A randomized, double-blind, placebo-controlled comparison of the effect of nitrofurantoin monohydrate macrocrystals on the development of urinary tract infections after surgery for pelvic organ prolapse and/or stress urinary incontinence with suprapubic catheterization. Am J Obstet Gynecol. 2004 Jul;191(1):182-7. doi: 10.1016/j.ajog.2004.03.088.

  PMID: 15295362 BACKGROUND

• Baertschi U, Kunz J. [Comparative study on the question of systemic chemoprophylaxis following gynecological surgery]. Schweiz Med Wochenschr. 1976 Mar 13;106(11):380-5. German.

  PMID: 1251156 BACKGROUND

• Gordon KA, Jones RN; SENTRY Participant Groups (Europe, Latin America, North America). Susceptibility patterns of orally administered antimicrobials among urinary tract infection pathogens from hospitalized patients in North America: comparison report to Europe and Latin America. Results from the SENTRY Antimicrobial Surveillance Program (2000). Diagn Microbiol Infect Dis. 2003 Apr;45(4):295-301. doi: 10.1016/s0732-8893(02)00467-4.

  PMID: 12730002 BACKGROUND

• Tyreman NO, Andersson PO, Kroon L, Orstam S. Urinary tract infection after vaginal surgery. Effect of prophylactic treatment with methenamine hippurate. Acta Obstet Gynecol Scand. 1986;65(7):731-3. doi: 10.3109/00016348609161491.

  PMID: 3544661 BACKGROUND

• Knoff T. [Methenamine hippurate. Short-term catheterization in gynecologic surgery. A double-blind comparison of Hiprex and placebo]. Tidsskr Nor Laegeforen. 1985 Mar 10;105(7):498-9. No abstract available. Norwegian.

  PMID: 3887639 BACKGROUND

• Ladehoff P, Jacobsen JC, Olsen H, Pedersen GT, Sorensen T. [The preventive effect of methenamine hippurate (Haiprex) on urinary infections after short-term catheterization. A clinical study]. Ugeskr Laeger. 1984 May 7;146(19):1433-4. No abstract available. Danish.

  PMID: 6515752 BACKGROUND

• Strom JG Jr, Jun HW. Effect of urine pH and ascorbic acid on the rate of conversion of methenamine to formaldehyde. Biopharm Drug Dispos. 1993 Jan;14(1):61-9. doi: 10.1002/bdd.2510140106.

  PMID: 8427945 BACKGROUND

• Marschall J, Carpenter CR, Fowler S, Trautner BW; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013 Jun 11;346:f3147. doi: 10.1136/bmj.f3147.

  PMID: 23757735 BACKGROUND

• Sutkin G, Alperin M, Meyn L, Wiesenfeld HC, Ellison R, Zyczynski HM. Symptomatic urinary tract infections after surgery for prolapse and/or incontinence. Int Urogynecol J. 2010 Aug;21(8):955-61. doi: 10.1007/s00192-010-1137-x. Epub 2010 Mar 31.

  PMID: 20354678 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 BACKGROUND

• Turck M, Stamm W. Nosocomial infection of the urinary tract. Am J Med. 1981 Mar;70(3):651-4. doi: 10.1016/0002-9343(81)90590-8.

  PMID: 7011018 BACKGROUND

• Duclos JM, Larrouturou P, Sarkis P. Timing of antibiotic prophylaxis with cefotaxime for prostatic resection: better in the operative period or at urethral catheter removal? Am J Surg. 1992 Oct;164(4A Suppl):21S-23S. doi: 10.1016/s0002-9610(06)80053-x.

  PMID: 1443356 BACKGROUND

• Lusardi G, Lipp A, Shaw C. Antibiotic prophylaxis for short-term catheter bladder drainage in adults. Cochrane Database Syst Rev. 2013 Jul 3;2013(7):CD005428. doi: 10.1002/14651858.CD005428.pub2.

  PMID: 23824735 BACKGROUND

• Lee BS, Bhuta T, Simpson JM, Craig JC. Methenamine hippurate for preventing urinary tract infections. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003265. doi: 10.1002/14651858.CD003265.pub3.

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Related Links

• Methenamine. In: Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc. \[updated 2/1/14; accessed 2/21/14\].
• Methenamine. In: Micromedex 2.0. Martindale - The Complete Drug Reference. Ann Arbor, MI: Truven Health Analytics. \[updated 8/20/2010; accessed 2/21/14\].
• Nitrofurantoin. In: Micromedex 2.0. Martindale - The Complete Drug Reference. Ann Arbor, MI: Truven Health Analytics. \[updated 8/20/2010; accessed 2/21/14\].
• Ciprofloxacin. In: Micromedex 2.0. Martindale - The Complete Drug Reference. Ann Arbor, MI: Truven Health Analytics. \[updated 8/20/2010; accessed 2/21/14\].
• Sulfamethoxazole/Trimethoprim. In: Micromedex 2.0. Martindale - The Complete Drug Reference. Ann Arbor, MI: Truven Health Analytics. \[updated 8/20/2010; accessed 2/21/14\].

MeSH Terms

Conditions

Urinary Tract Infections; Catheter-Related Infections

Interventions

methenamine hippurate; Ciprofloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Uduak Andy
• Organization: University of Pennsylvania

uduak.andy@pennmedicine.upenn.edu

215-662-7709

Study Officials

• Christine M Chu, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Lily Arya, MD, MS

  University of Pennsylvania

  STUDY DIRECTOR

• Daniel Lee, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 9, 2015
• Study Start: December 1, 2014
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 25, 2022
• Results First Posted: February 25, 2022

Record last verified: 2022-02

Locations

US (4)