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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorJahn Ferenc South Pest Teaching Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients aged between 18 and 80 years.

Interstitial cystitis/bladder pain syndrome (IC/BPS).

Recurrent urinary tract infections (UTIs).

Non-muscle invasive bladder cancer.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Catheter-Free Intravesical Instillation Patients1 intervention

Trial outcomes

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

Time frame
Up to two weeks.

Secondary outcomes

1

Success Rate of Catheter-Free Instillation

Proportion of instillation procedures successfully completed as judged by the treating physician.

Time frame
During each instillation visit.
2

Incidence of Post-Treatment Urinary Tract Infections

Occurrence of urinary tract infections post-treatment, confirmed by symptoms and positive urine culture.

Time frame
Within 1-2 weeks following the last instillation.
3

Incidence of Urethral Bleeding

Number of patients experiencing urethral bleeding during or after catheter-free intravesical instillation.

Time frame
Within 2 weeks following the last instillation.
4

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).

Time frame
Within 2 weeks following the last instillation.

Other outcomes

Sponsors and contacts

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