RecruitingNCT06719232

Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation

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


Sponsor

Jahn Ferenc South Pest Teaching Hospital

Enrollment

300 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria9

  • 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 Criteria4

  • 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.

Interventions

DEVICECatheter-Free Intravesical Instillation with a special syringe adapter

The intervention involves catheter-free intravesical instillation using a specialized urological adapter. This device is attached to a syringe and inserted approximately 6-8 mm into the urethral opening, allowing the instillation solution to reach the bladder without the need for catheterization.


Locations(2)

Military Hospital Medical Centre, Hungarian Defense Forces

Budapest, Hungary

Jahn Ferenc South-Pest Hospital

Budapest, Hungary

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NCT06719232


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