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
- Are there results?
- Not yet: the study is under way
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).
Show all 18Show fewer
- 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.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06907199
- Acronym / sponsor ID
- STU-2024-1187
- Conditions
- Recurrent UTIs, Cystitis Recurrent
- Keywords
- bladder fulguration, Nitrofurantoin, long-term managenent of cystitis, Recurrent UTI, chronic UTI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- University of Texas, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrofurantoin (NF) daily antibiotic prophylaxis | Active comparator | Drug: Nitrofurantoin (NF)Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months. |
| Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF) | Experimental | Procedure: Electrofulguration (EF), Drug: Nitrofurantoin (NF) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrofulguration (EF)Also: fulgurationNitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration. | Procedure or surgery | Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF) |
| Nitrofurantoin (NF)Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months. | Drug | Nitrofurantoin (NF) daily antibiotic prophylaxis, Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF) |
Primary outcome
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).
7 secondary outcomes
No recurring cystitis
Time frame: 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 multi-drug resistant organisms
Time frame: 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 behavior changes
Time frame: 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 UTI episodes
Time frame: Baseline to 30 months after enrollment to completion of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Recurrent UTIs
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
RecruitingPhase 3
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Recurrent Urinary Tract Infections in Women
Active, not recruiting
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Recurrent Urinary Tract Infection
RecruitingPhase 4
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Zimmern, M.D. contact
Philippe Zimmern, M.D. principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghan Leak (214-645-8787, utswuti@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of cystitis with NF vs EF+NF (time frame: Baseline to 30 months after enrollment to completion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.