Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation
NCT ID: NCT06719232
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-10-01
2025-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Catheter-Free Intravesical Instillation Patients
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosed bleeding disorders or recurrent macroscopic hematuria.
* Post-void residual urine volume greater than 100 ml.
* Mental condition that prevents reliable cooperation.
18 Years
80 Years
ALL
No
Sponsors
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Jahn Ferenc South Pest Teaching Hospital
OTHER_GOV
Responsible Party
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Dr. Béla Köves
Head Physician
Principal Investigators
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Peter Tenke, Professor of Urology
Role: STUDY_CHAIR
South Pest Teaching Hospital
Locations
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Military Hospital Medical Centre, Hungarian Defense Forces
Budapest, , Hungary
Jahn Ferenc South-Pest Hospital
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Marianna Nagy, Dr.
Role: primary
Zoltan Balogh, Dr
Role: primary
Other Identifiers
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NOCATIN
Identifier Type: -
Identifier Source: org_study_id