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

NCT06719232 | Recruiting

• 1 other identifier: NOCATIN
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

intravesical therapy; catheterization; recurrent urinary tract infection; IC/BPS; Interstitial Cystitis/Bladder Pain syndrome; Post-chemotherapy Cystitis; Post-Irradiation Cystitis; Intravesical instillation; UroDapter

Outcome Measures

Primary Outcomes (1)

• Patient Discomfort During Catheter-Free Intravesical Instillation

  Level of discomfort experienced by patients during catheter-free intravesical instillation treatments, measured using the Numerical Rating Scale (NRS) from 0 to 10

  Up to two weeks.

Secondary Outcomes (5)

• Success Rate of Catheter-Free Instillation

  During each instillation visit.

• Incidence of Post-Treatment Urinary Tract Infections

  Within 1-2 weeks following the last instillation.

• Incidence of Urethral Bleeding

  Within 2 weeks following the last instillation.

• Patient Preference for Catheter-Free Instillation

  Within 2 weeks following the last instillation.

• Incidence of Other Post-Treatment Complications

  Within 2 weeks following the last instillation.

Study Arms (1)

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.

Device: Catheter-Free Intravesical Instillation with a special syringe adapter

Interventions

Catheter-Free Intravesical Instillation with a special syringe adapter DEVICE

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.

Catheter-Free Intravesical Instillation Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients attending the participating centers. Study participants are individuals referred by their treating physicians for catheter-free intravesical instillation therapy based on their clinical needs.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jahn Ferenc South Pest Teaching Hospital: lead

Study Sites (2)

Military Hospital Medical Centre, Hungarian Defense Forces

Budapest, 1134, Hungary

RECRUITING

Jahn Ferenc South-Pest Hospital

Budapest, 1204, Hungary

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial; Cystitis; Cystitis, Hemorrhagic; Urinary Bladder Neoplasms; Urinary Bladder Diseases; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Infections

Study Officials

• Peter Tenke, Professor of Urology

  South Pest Teaching Hospital

  STUDY CHAIR

Central Study Contacts

Zoltan Balogh, Dr.

CONTACT

+3612896200; bkoves@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Physician

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

HU (2)