Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery

NCT02727322 | Completed Phase 4 Results

• 1 other identifier: PRO15110557
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo for patients undergoing short term indwelling or clean intermittent self-catheterization (CISC) for acute postoperative urinary retention following pelvic organ prolapse and/or urinary incontinence surgery. Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC or while indwelling catheter is in place. The primary outcome will be symptomatic and culture confirmed UTI within six weeks of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use, and incidence of nitrofurantoin-resistant isolates from urine culture of symptomatic women. 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 33% to 13%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 154 patients.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Urinary Tract Infection Within 6 Weeks of Surgery

  Frequency of symptomatic, culture-proven UTI; included participants who were empirically treated outside of protocol (symptoms but no culture) within 6 weeks of surgery. Positive culture was defined as at least 100,000 colony forming units (cfu)/ml of uropathic bacteria in a catheterized or midstream clean catch voided urine specimen.

  within 6 weeks of surgery

Secondary Outcomes (2)

• Number of Participants Who Experienced at Least One Adverse Event Symptom While Requiring Catheterization

  within 6 weeks of surgery

• Frequency of Urine Cultures Positive for Nitrofurantoin-resistant Isolates

  within 6 weeks of surgery

Study Arms (2)

Nitrofurantoin

ACTIVE COMPARATOR

Receives once daily nitrofurantoin 100mg

Drug: Nitrofurantoin

Placebo

PLACEBO COMPARATOR

Receives matching placebo

Drug: Placebo

Interventions

Nitrofurantoin DRUG

Patients will receive nitrofurantoin 100mg once daily or a placebo. Pills will be identical.

Also known as: Macrobid

Nitrofurantoin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• \- Women who have undergone surgery for the correction of pelvic organ prolapse and/or urinary incontinence and failed a postoperative voiding trial

You may not qualify if:

• Known drug allergy to nitrofurantoin
• History of renal insufficiency
• Renal transplant
• Renal nephropathy
• Recent history of more than 3 UTIs per year
• History of nitrofurantoin-induced pulmonary injury or nitrofurantoin associated cholestatic jaundice/hepatic dysfunction
• Known immunocompromised condition (organ transplant, chemotherapy, immune suppression associated with autoimmune disease).

Sponsors & Collaborators

• Halina M Zyczynski, MD: lead

Study Sites (2)

Georgetown/MedStar Hospital Center

Washington D.C., District of Columbia, 20007, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Lavelle ES, Alam P, Meister M, Florian-Rodriguez M, Elmer-Lyon C, Kowalski J, Carter-Brooks C, Mazloomdoost D, Zyczynski H, Lowder J, Gutman R, Sutkin G. Antibiotic Prophylaxis During Catheter-Managed Postoperative Urinary Retention After Pelvic Reconstructive Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Oct;134(4):727-735. doi: 10.1097/AOG.0000000000003462.

  PMID: 31503155 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The per protocol analysis did not meet power. Not powered for secondary outcomes - antibiotic resistance and adverse symptoms.

Results Point of Contact

• Title: Halina Zyczynski
• Organization: University of Pittsburgh

hzyczynski@upmc.edu

421-641-1440

Study Officials

• Erin S Lavelle, MD

  University of Pittsburgh

  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 INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 4, 2016
• Study Start: August 1, 2016
• Primary Completion: March 27, 2018
• Study Completion: May 12, 2018
• Last Updated: May 29, 2019
• Results First Posted: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)