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

July 22, 2026 updated by: Philippe Zimmern, University of Texas Southwestern Medical Center

A Multicentric Randomized Trial of Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for the Long-term Management of Cystitis in Women With Recurrent Urinary Tract Infections

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a study for women age 18 -85 with a well-documented history of rUTI (recurrent urinary tract infection) for at least one year. This randomized multicentric clinical trial will determine the efficacy of conventional 6 months Nitrofurantoin (NF) daily antibiotic prophylaxis alone versus electrofulguration (EF) associated with a 6 months NF daily antibiotic prophylactic course for early stages of chronic cystitis (stages 1 and 2) as determined on office cystoscopy.

This study will ask the participant (n=104) to return to the Urology clinic at UT Southwestern Medical Center (n=52) or The University of Kansas Medical Center (n=52) for a total of 8 compensated visits throughout 30 months after the start of this randomized trial to make sure that the treatment worked well for them.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Philippe Zimmern, M.D.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • The University of Kansas
        • Contact:
        • Principal Investigator:
          • Colby Souders, MD
    • Texas
      • Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Patients receiving phage therapy.
  • Current diagnosis of interstitial cystitis.
  • Patients with medical conditions requiring excessively large amounts of fluid intake.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Nitrofurantoin (NF) daily antibiotic prophylaxis
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Drug: Nitrofurantoin (NF)
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Experimental: Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)
Drug: Nitrofurantoin (NF)
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Procedure: Electrofulguration (EF)
Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
Other Names:
  • fulguration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment of cystitis with NF vs EF+NF
Time Frame: Baseline to 30 months after enrollment to completion of study
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
No recurring cystitis
Time Frame: Baseline to 30 months after enrollment to completion of study
Comparison of patient characteristics between the two enrolling institutions.
Baseline to 30 months after enrollment to completion of study
Rate comparison of culture-documented breakthrough
Time Frame: Baseline to 30 months after enrollment to completion of study
Rate of culture-documented breakthrough UTIs between the two treatment arms.
Baseline to 30 months after enrollment to completion of study
Rate of multi-drug resistant organisms
Time Frame: Baseline to 30 months after enrollment to completion of study
Rate of urine cultures showing multi-drug resistant organisms in each treatment arm.
Baseline to 30 months after enrollment to completion of study
Rate of non-urine culture
Time Frame: Baseline to 30 months after enrollment to completion of study
Rate of non-urine culture documented symptomatic UTI episodes for 12 months and 24 months following end of treatment arms, as determined by the Urinary Tract Infection Symptom Assessment (UTISA) (a total score of 3 or higher, or any individual score of 2 or 3) between the two treatment arms.
Baseline to 30 months after enrollment to completion of study
Rate of behavior changes
Time Frame: Baseline to 30 months after enrollment to completion of study
Rate of behavior changes in both groups (fluid increases or use of non-antibiotic therapies, e.g., cranberry, D-mannose, urinary analgesics, hormonal therapy) in each treatment arm.
Baseline to 30 months after enrollment to completion of study
Rate of score differences in symptoms and quality of life
Time Frame: Baseline to 30 months after enrollment to completion of study
Rate of score differences in patient symptoms and quality of life assessments using validated questionnaires- the Urinary Tract Infection Symptom Assessment (UTISA), Urinary Distress Inventory, Short Form (UDI-6), and Quality of Life scale (QoL) by Visual Analogue Scale (VAS) between both treatment arms.
Baseline to 30 months after enrollment to completion of study
Rate of UTI episodes
Time Frame: Baseline to 30 months after enrollment to completion of study
Rate of UTI episodes (after first and second year of the completion of the intervention) compared to the rate of UTI episodes prior to the start of study
Baseline to 30 months after enrollment to completion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
University of Texas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe Zimmern, M.D., University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU-2024-1187
  • 1R01DK140224-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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