Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery

NCT03287089 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00022622
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheterization following pelvic reconstructive surgery and/or urinary incontinence surgery. Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail their post-operative voiding trial will be included in the study. Upon successfully passing and in-office voiding trial at the time of catheter removal, they will be randomized to either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily for 5 days following catheter removal. The primary outcome will be the treatment of clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use and medication compliance. Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05, we should recruit a total of 164 patients.

Conditions

Catheter-Associated Urinary Tract Infection

Keywords

Nitrofurantoin; Prolapse; Pelvic Organ Prolapse; Anti-incontinence procedure; Urinary retention; Urinary Tract Infection; Short-term catheterization

Outcome Measures

Primary Outcomes (1)

• UTI

  Number of participants with a urinary tract infection in the first 30 days following pelvic reconstructive surgery

  within 30 days of surgery

Secondary Outcomes (2)

• Adverse Events

  within 30 days of surgery

• Medication Compliance

  within 30 days of surgery

Study Arms (2)

Nitrofurantoin

ACTIVE COMPARATOR

Receives twice daily 100mg nitrofurantoin for 5 days following catheter removal

Drug: Nitrofurantoin 100 MG

Placebo

PLACEBO COMPARATOR

Receives twice daily matching placebo for 5 days following catheter removal

Drug: Placebo Oral Tablet

Interventions

Nitrofurantoin 100 MG DRUG

Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days

Nitrofurantoin

Placebo Oral Tablet DRUG

Matching placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Age greater than 18
• Creatinine clearance greater than 30 ml/min
• Failed postoperative hospital voiding trial

You may not qualify if:

• Pregnant
• History of glucose-6-phosphate dehydrogenase deficiency
• History of renal insufficiency, renal transplant, or nephropathy
• Allergy to nitrofurantoin
• History of recurrent UTI (defined as greater than two culture-proven infections in six months or three infections in one year)
• Urinary Tract Infection (UTI) within 14 days one month of surgery
• Non-English speaking
• Urinary tract infection while Foley catheter is in place
• On antibiotic therapy for other non-urological reasons
• Sustained intraoperative bladder injury requiring prolonged catheterization greater than 5 days
• Undergoing mesh excision from within the bladder, fistula repair, cystotomy repair, urethral diverticulectomy, sacral neuromodulation, urethral surgery, or any other procedure requiring prolonged catheterization and bladder decompression
• Placement of a suprapubic catheter
• Participants that request intermittent self-catheterization
• Neurologic conditions affecting urinary tract system and normal voiding mechanisms
• History of hepatic impairment due to prior nitrofurantoin use

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28207, United States

Location

Related Publications (22)

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  PMID: 1348797 BACKGROUND

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  PMID: 17120175 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

• Jackson D, Higgins E, Bracken J, Yandell PM, Shull B, Foster RT Sr. Antibiotic prophylaxis for urinary tract infection after midurethral sling: a randomized controlled trial. Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):137-41. doi: 10.1097/SPV.0b013e318285ba53.

  PMID: 23611930 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, Visco AG, Siddiqui NY. Treatment for urinary tract infection after midurethral sling: a retrospective study comparing patients who receive short-term postoperative catheterization and patients who pass a void trial on the day of surgery. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):175-8. doi: 10.1097/SPV.0b013e3182544e03.

  PMID: 22543772 BACKGROUND

• Vigil HR, Mallick R, Nitti VW, Lavallee LT, Breau RH, Hickling DR. Risk Factors for Urinary Tract Infection following Mid Urethral Sling Surgery. J Urol. 2017 May;197(5):1268-1273. doi: 10.1016/j.juro.2016.12.093. Epub 2016 Dec 27.

  PMID: 28034608 BACKGROUND

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  PMID: 12174159 BACKGROUND

• Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.

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• 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

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  PMID: 18401538 BACKGROUND

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  PMID: 15295362 BACKGROUND

• Wolf SJ, Bennett CJ, Dmochowski RR et al. (2012). Urologic Surgery Antimicrobial Prophylaxis. American Urological Association. Retrieved from http://www.auanet.org/guidelines/antimicrobial-prophylaxis-(2008-reviewed-and-validity-confirmed-2011-amended-2012)

  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.

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• Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.

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  PMID: 11788540 BACKGROUND

• Goettsch WG, Janknegt R, Herings RM. Increased treatment failure after 3-days' courses of nitrofurantoin and trimethoprim for urinary tract infections in women: a population-based retrospective cohort study using the PHARMO database. Br J Clin Pharmacol. 2004 Aug;58(2):184-9. doi: 10.1111/j.1365-2125.2004.02106.x.

  PMID: 15255801 BACKGROUND

• Bastawros D, Kaczmarski K, Zhao J, Bender R, Myers E, Tarr ME. Twice-Daily Nitrofurantoin Administration Following Short-term Transurethral Catheterization After Pelvic Reconstructive Surgery: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):202-207. doi: 10.1097/SPV.0000000000000977.

  PMID: 33620905 DERIVED

MeSH Terms

Conditions

Prolapse; Pelvic Organ Prolapse; Urinary Retention; Urinary Tract Infections

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dina Bastawros, MD
• Organization: Atrium Health

dina.bastawros@gmail.com

336-718-1970

Study Officials

• Dina Bastawros, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 15, 2017
• First Posted: September 19, 2017
• Study Start: September 29, 2017
• Primary Completion: May 30, 2019
• Study Completion: June 1, 2019
• Last Updated: August 9, 2022
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)