Interstitial CystitisNOCATINNCT06719232
Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation
An observational study of Interstitial Cystitis and Recurrent Cystitis, run by Jahn Ferenc South Pest Teaching Hospital at 2 sites in Hungary.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Cystitis, Recurrent Cystitis, Haemorrhagic Cystitis
- What is being tested?
- Catheter-Free Intravesical Instillation with a special syringe adapter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 300 participants
- Where
- 2 sitesHungary
- Study dates
- 1 Oct 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
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- Post-chemotherapy cystitis.
- Negative urine culture within the last two weeks.
- Patients who provide verbal and written informed consent to participate in the study.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary2 sites, 2 recruiting
- Recruiting
Military Hospital Medical Centre, Hungarian Defense Forces
Budapest, 1134
Marianna Nagy, Dr., +36 1 465 1800, bkoves@gmail.com
- Recruiting
Jahn Ferenc South-Pest Hospital
Budapest, 1204
Zoltan Balogh, Dr, +3612896200, bkoves@gmail.com
About this study
Official title: Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Interstitial Cystitis, Recurrent Cystitis, Haemorrhagic Cystitis, Bladder Cancer, Bladder Disease, Intravesical Instillation
- Being tested
- Catheter-Free Intravesical Instillation with a special syringe adapter
- Keywords
- intravesical therapy, catheterization, recurrent urinary tract infection, IC/BPS, Interstitial Cystitis/Bladder Pain syndrome, Post-chemotherapy Cystitis, Post-Irradiation Cystitis, Intravesical instillation, UroDapter
- Medical subject headings
- Cystitis, Interstitial, Cystitis, Cystitis, Hemorrhagic, Urinary Bladder Neoplasms, Urinary Bladder Diseases, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter-Free Intravesical Instillation with a special syringe adapterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Catheter-Free Intravesical Instillation with a special syringe adapter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to two weeks.
Secondary outcomes (5)
Success Rate of Catheter-Free Instillation
Proportion of instillation procedures successfully completed as judged by the treating physician.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Within 2 weeks following the last instillation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jahn Ferenc South Pest Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Béla Köves, Jahn Ferenc South Pest Teaching Hospital
- Investigators
- Peter Tenke, Professor of Urology, Study chair, South Pest Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719232
- Sponsor's protocol ID
- NOCATIN
- Acronym
- NOCATIN
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06719232
- Acronym / sponsor ID
- NOCATIN / NOCATIN
- Conditions
- Interstitial Cystitis, Recurrent Cystitis, Haemorrhagic Cystitis, Bladder Cancer, Bladder Disease, Intravesical Instillation
- Keywords
- intravesical therapy, catheterization, recurrent urinary tract infection, IC/BPS, Interstitial Cystitis/Bladder Pain syndrome, Post-chemotherapy Cystitis, Post-Irradiation Cystitis, Intravesical instillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jahn Ferenc South Pest Teaching HospitalOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter-Free Intravesical Instillation Patients | – | Device: Catheter-Free Intravesical Instillation with a special syringe adapterThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter-Free Intravesical Instillation with a special syringe adapterThe 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. | Device | Catheter-Free Intravesical Instillation Patients |
Primary outcome
Patient Discomfort During Catheter-Free Intravesical Instillation
Time frame: Up to two weeks.
Level of discomfort experienced by patients during catheter-free intravesical instillation treatments, measured using the Numerical Rating Scale (NRS) from 0 to 10
5 secondary outcomes
Success Rate of Catheter-Free Instillation
Time frame: During each instillation visit.
Incidence of Post-Treatment Urinary Tract Infections
Time frame: Within 1-2 weeks following the last instillation.
Incidence of Urethral Bleeding
Time frame: Within 2 weeks following the last instillation.
Patient Preference for Catheter-Free Instillation
Time frame: Within 2 weeks following the last instillation.
Incidence of Other Post-Treatment Complications
Time frame: Within 2 weeks following the last instillation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Tenke, Professor of Urology study chair
South Pest Teaching Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis and Recurrent Cystitis, run by Jahn Ferenc South Pest Teaching Hospital at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoltan Balogh, Dr. (+3612896200, bkoves@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Discomfort During Catheter-Free Intravesical Instillation (time frame: Up to two weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.