Evaluating a catheter-free method for bladder medication delivery
Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study
Jahn Ferenc South Pest Teaching Hospital · NCT06719232
This study is testing a new way to deliver bladder medication without a catheter to see if it’s more comfortable and safer for people with conditions like interstitial cystitis and recurrent urinary tract infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Jahn Ferenc South Pest Teaching Hospital (other gov) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Budapest and 1 other locations) |
| Trial ID | NCT06719232 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and patient experience of a catheter-free method for intravesical instillation, which delivers medications directly into the bladder for conditions like interstitial cystitis and recurrent urinary tract infections. The approach utilizes a specialized urological adapter that allows for painless delivery without traditional catheterization, potentially reducing discomfort and complications. By collecting data on patient outcomes and experiences, the study seeks to determine if this method is a safer and more comfortable alternative to conventional treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 who require intravesical therapy for conditions such as interstitial cystitis or recurrent urinary tract infections.
Not a fit: Patients with active urinary tract infections, bleeding disorders, or those unable to cooperate due to mental conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a more comfortable and effective treatment option for patients with bladder-related conditions.
How similar studies have performed: While catheter-free intravesical instillations have been performed in Hungary since 2018, this study aims to formally evaluate their efficacy and patient experience, making it a novel approach in a broader context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients aged between 18 and 80 years. * Patients for whom the treating physician has determined that intravesical instillation is necessary due to one of the following conditions: * Interstitial cystitis/bladder pain syndrome (IC/BPS). * Recurrent urinary tract infections (UTIs). * Non-muscle invasive bladder cancer. * Post-radiation cystitis. * Post-chemotherapy cystitis. * Negative urine culture within the last two weeks. * Patients who provide verbal and written informed consent to participate in the study. Exclusion Criteria: * Urinary tract infection within the past month or currently active infection. * Diagnosed bleeding disorders or recurrent macroscopic hematuria. * Post-void residual urine volume greater than 100 ml. * Mental condition that prevents reliable cooperation.
Where this trial is running
Budapest and 1 other locations
- Military Hospital Medical Centre, Hungarian Defense Forces — Budapest, Hungary (RECRUITING)
- Jahn Ferenc South-Pest Hospital — Budapest, Hungary (RECRUITING)
Study contacts
- Study coordinator: Zoltan Balogh, Dr.
- Email: bkoves@gmail.com
- Phone: +3612896200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Interstitial Cystitis, Recurrent Cystitis, Haemorrhagic Cystitis, Bladder Cancer, Bladder Disease, Intravesical Instillation, Bladder Pain Syndrome, Recurrent Urinary Tract Infections