Actively Recruiting

Phase 1
Age: 18Years - 85Years
FEMALE
NCT06907199

Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections

Led by University of Texas Southwestern Medical Center · Updated on 2026-05-01

104

Participants Needed

2

Research Sites

147 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

U

University of Texas

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if the drug Nitrofurantoin (NF) taken as a daily antibiotic, works to treat cystitis compared to electrofulguration (EF) and Nitrofurantoin (NF) daily antibiotic.

CONDITIONS

Official Title

Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections

Who Can Participate

Age: 18Years - 85Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 85 years with a history of culture documented uncomplicated recurrent urinary tract infections for at least 1 year
  • Diagnosis of recurrent urinary tract infections defined as at least 3 symptomatic UTIs in 12 months or at least 2 in 6 months
  • Currently free from urinary tract infection symptoms and negative urine culture with less than 10^3 colony forming units per ml
  • Negative upper and lower urinary tract evaluation including pelvic exam showing pelvic organ prolapse stage 2 or less, post-void residual less than 50 ml, and imaging excluding kidney stones, hydronephrosis, reflux, or urethral diverticulum
  • Office cystoscopy showing stage 1 or 2 chronic cystitis
  • Likely to remain in the geographic area for the study duration
  • ASA physical status class II or less
Not Eligible

You will not qualify if you...

  • Use of antibiotics at baseline for suppressive therapy or non-urinary infections
  • Use of self-start antibiotic therapy for urinary symptoms
  • Use of prophylactic antibiotics started within the last 3 months and unwilling to stop, or plans to start in the next 12 months
  • Complicated urinary tract infections including neurogenic bladder, bladder augmentation, or urinary diversion
  • Presence of urinary catheters including indwelling Foley, intermittent catheterization, or suprapubic catheters
  • Uncontrolled diabetes with HbA1c greater than 9
  • Pregnancy
  • Allergy or resistance to Nitrofurantoin
  • Chronic lung or liver conditions preventing Nitrofurantoin use, including abnormal chest X-ray or elevated liver tests
  • Chronic kidney insufficiency with creatinine over 1.5 g/dl or GFR less than 40
  • History of chronic diarrhea requiring regular treatment
  • Psychosis, dementia, swallowing disorders, or inability to take Nitrofurantoin reliably at home
  • Body mass index over 40
  • Use of Uromune or other vaccines to reduce recurrent urinary tract infections
  • Participation in investigational research in the past 12 weeks
  • Receiving phage therapy
  • Current diagnosis of interstitial cystitis
  • Medical conditions requiring excessive fluid intake

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The University of Kansas

Kansas City, Kansas, United States, 66160

Not Yet Recruiting

2

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

M

Meghan Leak

CONTACT

P

Philippe Zimmern, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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