Trials / Recruiting
RecruitingNCT06907199
Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Electrofulguration (EF) | Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration. |
| DRUG | Nitrofurantoin (NF) | Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months. |
Timeline
- Start date
- 2026-04-30
- Primary completion
- 2028-07-01
- Completion
- 2029-01-30
- First posted
- 2025-04-02
- Last updated
- 2026-04-07
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06907199. Inclusion in this directory is not an endorsement.