Nitrofurantoin and Urinary Tract Infections (UTIs)

NCT00678041 | Terminated Results

• 1 other identifier: SutkinAppic
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects. This study will not require any additional visits or blood draws. You will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a UTI to your doctor.

Conditions

Urinary Tract Infections

Keywords

urinary catheterization; urinary tract infection; urinary incontinence; pelvic floor prolapse; antibiotics

Outcome Measures

Primary Outcomes (1)

• Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation

  Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.

  6 to 8 weeks after surgery

Secondary Outcomes (6)

• Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI

  6 weeks after surgery

• Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.

  6 weeks after surgery

• Adherence to CISC

  6 weeks after surgery

• Patient Perceptions Regarding CISC

  6 weeks after surgery

• Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria

  6 weeks after surgery

Study Arms (2)

Arm 1: Nitrofurantoin Group

EXPERIMENTAL

extended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Drug: Nitrofurantoin

Arm 2: Placebo Group

PLACEBO COMPARATOR

identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Drug: Placebo

Interventions

Nitrofurantoin DRUG

nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Also known as: Macrodantin

Arm 1: Nitrofurantoin Group

Placebo DRUG

Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Arm 2: Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (CISC) prior to discharge from the hospital

You may not qualify if:

• Known drug allergy to nitrofurantoin
• A history of renal insufficiency
• Renal transplant
• Renal nephropathy
• A recent history of more than 3 Urinary Tract Infections (UTIs) per year
• Known immunocompromised condition (organ transplant, chemotherapy for cancer or arthritis, autoimmune diseases (lupus etc)).

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Urinary Incontinence

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data

Results Point of Contact

• Title: Gary Sutkin, MD
• Organization: University of Pittsburgh, UPP13 WH Uro Gynecology - Cor

gsutkin@mail.magee.edu

412--641-1440

Study Officials

• Gary Sutkin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 10, 2008
• First Posted: May 15, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 27, 2016
• Results First Posted: August 2, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)