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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Cystitis; Bladder Cancer; Interstitial Cystitis; Bladder Disease; Bladder Pain Syndrome; Haemorrhagic Cystitis; Recurrent Urinary Tract Infections; Intravesical Instillation
• Intervention / Treatment: Device: Catheter-Free Intravesical Instillation with a special syringe adapter

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Zoltan Balogh, Dr.; Phone Number: +3612896200; Email: bkoves@gmail.com

Study Locations

• Hungary
  • Budapest, Hungary, 1134
    • Recruiting
    • Military Hospital Medical Centre, Hungarian Defense Forces
    • Contact: Marianna Nagy, Dr.; Phone Number: +36 1 465 1800; Email: bkoves@gmail.com
  • Budapest, Hungary, 1204
    • Recruiting
    • Jahn Ferenc South-Pest Hospital
    • Contact: Zoltan Balogh, Dr; Phone Number: +3612896200; Email: bkoves@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of Catheter-Free Instillation	Proportion of instillation procedures successfully completed as judged by the treating physician.	During each instillation visit.
Incidence of Post-Treatment Urinary Tract Infections	Occurrence of urinary tract infections post-treatment, confirmed by symptoms and positive urine culture.	Within 1-2 weeks following the last instillation.
Incidence of Urethral Bleeding	Number of patients experiencing urethral bleeding during or after catheter-free intravesical instillation.	Within 2 weeks following the last instillation.
Patient Preference for Catheter-Free Instillation	Percentage of patients preferring catheter-free intravesical instillation compared to previous catheter-based treatments (only in the sub-group of pts who had previous catheter-based treatments).	Within 2 weeks following the last instillation.
Incidence of Other Post-Treatment Complications	Any additional complications related to catheter-free intravesical instillation, including pain or discomfort beyond expected levels.	Within 2 weeks following the last instillation.

Collaborators and Investigators

• Sponsor: Jahn Ferenc South Pest Teaching Hospital
• Investigators: Study Chair: Peter Tenke, Professor of Urology, South Pest Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 7, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: catheterization; recurrent urinary tract infection; IC/BPS; Intravesical instillation; intravesical therapy; Interstitial Cystitis/Bladder Pain syndrome; Post-chemotherapy Cystitis; Post-Irradiation Cystitis; UroDapter
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Recurrence; Urinary Tract Infections; Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases
• Other Study ID Numbers: NOCATIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No