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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Catheter-Free Intravesical Instillation with a special syringe adapter
DeviceThe 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
Success Rate of Catheter-Free Instillation
Proportion of instillation procedures successfully completed as judged by the treating physician.
Incidence of Post-Treatment Urinary Tract Infections
Occurrence of urinary tract infections post-treatment, confirmed by symptoms and positive urine culture.
Incidence of Urethral Bleeding
Number of patients experiencing urethral bleeding during or after catheter-free intravesical 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).
Sponsors and contacts
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