Clinical trial · Observational
Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation
Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Disease | — | UNRESOLVED | — |
| Bladder Pain Syndrome | — | UNRESOLVED | — |
| Haemorrhagic Cystitis | — | UNRESOLVED | — |
| Interstitial Cystitis | — | UNRESOLVED | — |
| Intravesical Instillation | — | UNRESOLVED | — |
| Recurrent Cystitis | — | UNRESOLVED | — |
| Recurrent Urinary Tract Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Catheter-Free Intravesical Instillation with a special syringe adapter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Catheter-Free Intravesical Instillation Patients
- description
- 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.
- interventionNames
- Device: Catheter-Free Intravesical Instillation with a special syringe adapter
Primary outcomes (1)
- measure
- Patient Discomfort During Catheter-Free Intravesical Instillation
- timeFrame
- Up to two weeks.
- description
- 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 (5)
- measure
- Success Rate of Catheter-Free Instillation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available