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.
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
300
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.
Military Hospital Medical Centre, Hungarian Defense Forces
Budapest, Hungary
RECRUITINGJahn Ferenc South-Pest Hospital
Budapest, Hungary
RECRUITINGPatient 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.
Success Rate of Catheter-Free Instillation
Proportion of instillation procedures successfully completed as judged by the treating physician.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Within 2 weeks following the last instillation.
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