Actively Recruiting
Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study
Led by Jahn Ferenc South Pest Teaching Hospital · Updated on 2024-12-12
300
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a catheter-free method for delivering medications directly into the bladder, called intravesical instillation. This method is commonly used for conditions such as interstitial cystitis/bladder pain syndrome (IC/BPS), recurrent urinary tract infections, bladder cancer, and post-chemotherapy or post-radiation cystitis. The study investigates whether this approach reduces discomfort and complications while maintaining treatment effectiveness compared to traditional catheter-based methods. The treatment involves using a specialized urological adapter called UroDapter, which attaches to a syringe and is inserted about 6-8 mm into the urethral opening. This allows medication to reach the bladder without catheterization, aiming to minimize pain, discomfort, and risks like urinary tract infections and urethral damage. Patients receive catheter-free intravesical instillation therapy as their physicians recommend, covering various bladder conditions. Participants will be monitored for up to two weeks to assess patient discomfort during the catheter-free instillation. Researchers will also track success rates of the procedure, incidence of urinary tract infections, urethral bleeding, other complications, and patient preference for this method. Data will be collected anonymously to improve treatment protocols, patient satisfaction, and compliance with intravesical therapies.
CONDITIONS
Brief Title
Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged between 18 and 80 years
- Patients requiring intravesical instillation for interstitial cystitis/bladder pain syndrome (IC/BPS), recurrent urinary tract infections (UTIs), non-muscle invasive bladder cancer, post-radiation cystitis, or post-chemotherapy cystitis
- Negative urine culture within the last two weeks
- Provided verbal and written informed consent to participate in the study
You will not qualify if you...
- Urinary tract infection within the past month or currently active infection
- Diagnosed bleeding disorders or recurrent visible blood in urine
- Post-void residual urine volume greater than 100 ml
- Mental condition that prevents reliable cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to two weeks
Participants receive catheter-free intravesical instillations using a specialized urological adapter inserted 6-8 mm into the urethral opening to deliver treatment directly into the bladder without catheterization.
Multiple instillation visits over up to two weeks
Duration - Up to 2 weeks following the last instillation
Participants are monitored for complications such as urinary tract infections, urethral bleeding, and other post-treatment issues, as well as patient preference and treatment success.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 2 locations
1
Military Hospital Medical Centre, Hungarian Defense Forces
Budapest, Hungary, 1134
Actively Recruiting
2
Jahn Ferenc South-Pest Hospital
Budapest, Hungary, 1204
Actively Recruiting
Research Team
Z
Zoltan Balogh, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here