An observational study in Interstitial Cystitis, Recurrent Cystitis and Haemorrhagic Cystitis, sponsored by Jahn Ferenc South Pest Teaching Hospital. Recruiting at 2 sites in Hungary. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Jahn Ferenc South Pest Teaching Hospital · Observational
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 63 observational studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Jahn Ferenc South Pest Teaching Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2025, 14 months after the start.
Of 21 observational studies under Cystitis, Interstitial, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 69. This study's planned 14 months is below that.
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Jahn Ferenc South Pest Teaching Hospital