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

NCT06907199 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STU-2024-11871R01DK140224-01A1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

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

Recurrent UTIs; Cystitis Recurrent

Keywords

bladder fulguration; Nitrofurantoin; long-term managenent of cystitis; Recurrent UTI; chronic UTI

Outcome Measures

Primary Outcomes (1)

• Treatment of cystitis with NF vs EF+NF

  Rate of culture documented symptomatic UTIs following the completion of each 6-month study arm intervention. Specifically, from 6 to 18 months (first year) after the completion of the original intervention and, 18 to 30 months (second year).

  Baseline to 30 months after enrollment to completion of study

Secondary Outcomes (7)

• No recurring cystitis

  Baseline to 30 months after enrollment to completion of study

• Rate comparison of culture-documented breakthrough

  Baseline to 30 months after enrollment to completion of study

• Rate of multi-drug resistant organisms

  Baseline to 30 months after enrollment to completion of study

• Rate of non-urine culture

  Baseline to 30 months after enrollment to completion of study

• Rate of behavior changes

  Baseline to 30 months after enrollment to completion of study

Study Arms (2)

Nitrofurantoin (NF) daily antibiotic prophylaxis

ACTIVE COMPARATOR

Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.

Drug: Nitrofurantoin (NF)

Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)

EXPERIMENTAL

Procedure: Electrofulguration (EF); Drug: Nitrofurantoin (NF)

Interventions

Electrofulguration (EF) PROCEDURE

Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.

Also known as: fulguration

Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)

Nitrofurantoin (NF) DRUG

Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.

Nitrofurantoin (NF) daily antibiotic prophylaxis; Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Biologically born female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females 18 to 85 years old with at least a 1-year history of culture documented uncomplicated rUTI.
• Diagnosis of rUTI, defined as ≥ 3 symptomatic UTIs in 12 months or ≥ 2 in 6 months.
• Currently free from a UTI determined based on absence of symptoms as determined by the UTI symptom assessment questionnaire and negative urine culture (\<10\^3 colony forming units per ml of urine).
• A negative upper and lower urinary tract evaluation, including pelvic examination for pelvic organ prolapse (less than or equal to stage 2), measurement of post-void residual (less than 50 ml), and imaging (which may include renal ultrasound and standing voiding cystourethrogram) to exclude kidney stone, hydronephrosis, reflux, or urethral diverticulum.
• Office cystoscopy documenting stages 1 or 2 of chronic cystitis.
• Likely to stay in the geographic region for the duration of the study.
• ASA class II or less.

You may not qualify if:

• Patients on antibiotics at baseline (i.e., suppressive therapy or antibiotic therapy for non-urinary infections).
• Patients on self-start therapy (i.e., taking antibiotics upon start of urinary symptoms concerning for UTI).
• Patients on prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months.
• Complicated UTIs, including neurogenic bladder condition (i.e., multiple sclerosis, Parkinson's disease, spinal cord injury), bladder augmentation, or urinary diversion.
• Patients with urinary catheters (including indwelling Foley, intermittent catheterization, and suprapubic catheters).
• Uncontrolled diabetes (HbA1c \>9).
• Pregnancy
• Allergy or resistance to Nitrofurantoin.
• Chronic lung or liver condition precluding the use of Nitrofurantoin, including abnormal chest X ray or elevated liver function tests.
• Chronic renal insufficiency (creatinine over 1.5 g/dl or GFR less than 40) precluding the use of Nitrofurantoin.
• History of chronic diarrhea requiring regular therapy.
• Patients with psychosis, dementia, swallowing disorders, or any other ability to take Nitrofurantoin reliably at home.
• BMI over 40.
• Use of Uromune or other vaccine approaches to reduce rUTI episodes
• Participation in a research study involving an investigational product in the past 12 weeks.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Texas Southwestern Medical Center: lead
• University of Texas: collaborator

Study Sites (2)

The University of Kansas

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Diathermy; Nitrofurantoin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Philippe Zimmern, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan Leak

CONTACT

214-645-8787; utswuti@utsouthwestern.edu

Philippe Zimmern, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 2, 2025
• Study Start: April 6, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)