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

ClinicalTrials.gov ID

NCT06719232

Lead Sponsor

Jahn Ferenc South Pest Teaching HospitalOTHER_GOV

Overall Status

Recruiting

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Dec 12, 2024Actual

Start Date

Oct 1, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

Official Title

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

Brief 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.

Detailed Description

Intravesical instillation, a method involving the direct administration of therapeutic agents into the bladder via a catheter, is widely used in the treatment of various urological conditions, including interstitial cystitis/bladder pain syndrome (IC/BPS), recurrent urinary tract infections (UTIs), post-chemotherapy and post-radiation cystitis, and non-muscle invasive bladder cancer. This approach allows high concentrations of medication to be delivered directly to the bladder without systemic exposure, thereby enhancing treatment efficacy while reducing the risk of systemic side effects.

A notable drawback of traditional intravesical treatments is the need for catheterization. However, catheter-free intravesical instillations have become possible with the use of a specialized urological adapter that requires only 6-8 mm insertion into the urethral opening (UroDapter). By relaxing the urethral sphincter, patients can facilitate the delivery of the instillation fluid into the bladder without a catheter. This method is painless, causes minimal discomfort, and significantly reduces the risk of urinary tract infections, urethral bleeding, and urethral strictures compared to catheter-based approaches. Catheter-free intravesical instillations have been performed in Hungarian outpatient urology settings since 2018.

This prospective observational study includes patients whose physicians recommended catheter-free bladder instillation therapy. The study aims to anonymously collect data on the treatment's effectiveness, patient experience and incidence of complications associated with the caheter-free approach, focusing on its application for IC/BPS, recurrent UTIs, post-chemotherapy and post-radiation cystitis, and bladder cancer. Findings will be instrumental in refining protocols for intravesical treatments and enhancing patient compliance and satisfaction.

• Interstitial Cystitis
• Recurrent Cystitis
• Haemorrhagic Cystitis
• Bladder Cancer
• Bladder Disease
• Intravesical Instillation
• Bladder Pain Syndrome
• Recurrent Urinary Tract Infections

• Catheter-Free Intravesical Instillation with a special syringe adapter

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Jahn Ferenc South Pest Teaching HospitalOTHER_GOV

bkoves@gmail.com+3612896200

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