Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

This study aims to evaluate a catheter-free method for delivering medications directly into the bladder, known as intravesical instillation, which is commonly used to treat 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 method, which eliminates the need for catheterization, reduces discomfort and complications while maintaining treatment effectiveness. By collecting data on patient experiences and outcomes, the study seeks to determine if this approach provides a safer and more comfortable alternative to traditional catheter-based treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hungary
Jahn Ferenc South-Pest Hospital
RECRUITING
Budapest
Military Hospital Medical Centre, Hungarian Defense Forces
RECRUITING
Budapest
Contact Information
Primary
Zoltan Balogh, Dr.
bkoves@gmail.com
+3612896200
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 300
Treatments
Catheter-Free Intravesical Instillation Patients
This group consists of patients receiving catheter-free intravesical instillation treatments with a special syringe adapter, called UroDapter for any conditions, including interstitial cystitis/bladder pain syndrome (IC/BPS), recurrent urinary tract infections (UTIs), post-chemotherapy cystitis, post-radiation cystitis, and non-muscle invasive bladder cancer.
Sponsors
Leads: Jahn Ferenc South Pest Teaching Hospital

This content was sourced from clinicaltrials.gov

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