Recurrent UTIsPhase 1NCT06907199
Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
A Phase 1 study testing Electrofulguration (EF) and Nitrofurantoin (NF) in people with Recurrent UTIs and Cystitis Recurrent, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Recurrent UTIs, Cystitis Recurrent
- What is being tested?
- Electrofulguration (EF) and Nitrofurantoin (NF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Apr 2026to 30 Jan 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Philippe Zimmern, M.D. contact
United States2 sites, 2 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Meghan B Leak, 214-645-8787, meghan.leak@utsouthwestern.edu
Jessica de Araujo Paula, 214-645-8787, jessica.dearaujopaula@utsouthwestern.edu
- Not yet recruiting
The University of Kansas
Kansas City, Kansas, 66160
Colby Souders, MD, 913-588-6146, csouders@kumc.edu
Colby Souders, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Recurrent UTIs, Cystitis Recurrent
- Being tested
- Electrofulguration (EF), Nitrofurantoin (NF)
- Keywords
- bladder fulguration, Nitrofurantoin, long-term managenent of cystitis, Recurrent UTI, chronic UTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrofulguration (EF)Procedure or surgery
Also called fulguration
Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
Nitrofurantoin (NF)Drug
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Nitrofurantoin (NF) daily antibiotic prophylaxis | Active comparator | Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months. Receives: Drug: Nitrofurantoin (NF) |
| Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF) | Experimental | Not described Receives: Procedure: Electrofulguration (EF); Drug: Nitrofurantoin (NF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 30 months after enrollment to completion of study
Secondary outcomes (7)
No recurring cystitis
Comparison of patient characteristics between the two enrolling institutions.
Measured: Baseline to 30 months after enrollment to completion of study
Rate comparison of culture-documented breakthrough
Rate of culture-documented breakthrough UTIs between the two treatment arms.
Measured: Baseline to 30 months after enrollment to completion of study
Rate of multi-drug resistant organisms
Rate of urine cultures showing multi-drug resistant organisms in each treatment arm.
Measured: Baseline to 30 months after enrollment to completion of study
Rate of non-urine culture
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.
Measured: Baseline to 30 months after enrollment to completion of study
Rate of behavior changes
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.
Measured: Baseline to 30 months after enrollment to completion of study
Rate of score differences in symptoms and quality of life
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.
Measured: Baseline to 30 months after enrollment to completion of study
Rate of UTI episodes
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
Measured: Baseline to 30 months after enrollment to completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start6 Apr 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent UTIsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Philippe Zimmern, University of Texas Southwestern Medical Center
- Investigators
- Philippe Zimmern, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907199
- Sponsor's protocol ID
- STU-2024-1187
- Other IDs
- 1R01DK140224-01A1
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No