Interstitial Cystitis, ChronicIaluadapterNCT06540248
Real-life Clinical Experience With Ialuadapter Study
An observational study of Interstitial Cystitis, Chronic and Overactive Bladder Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Chronic, Overactive Bladder Syndrome, Recurrent Urinary Tract Infection
- What is being tested?
- Ialuadapter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients with IC/BPS, recurrent UTIs and/or OAB * Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).
Who may be able to join
- Patients with IC/BPS, recurrent UTIs and/or OAB
- Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).
Who cannot join
- Patients with a high post-void residue of >100ml or with an indwelling catheter were excluded from the analyses.
- Patients who cannot sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-life Clinical Experience With a Minimally Invasive Syringe Adapter for Catheter Free Instillation of Intravesical Treatments
A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.
Read the detailed description
Introduction Intravesical treatment is currently dependent on catheterization which can cause urethral discomfort and risk of urinary tract infections in selected patient groups such as interstitial cystitis / bladder pain syndrome (IC/BPS), overactive bladder syndrome (OAB) and recurrent urinary tract infections (rUTI). This study describes real-life clinical experience of a minimally invasive syringe adapter (Ialudapter®) for catheter-free instillation of intravesical treatment.
Methods A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.
- Conditions
- Interstitial Cystitis, Chronic, Overactive Bladder Syndrome, Recurrent Urinary Tract Infection
- Being tested
- Ialuadapter
- Keywords
- IALUDAPTER, intravesical therapy, GAG therapy, Intravesical treatment, IC/BPS, recurrent urine tract infection, catheterization
- Medical subject headings
- Cystitis, Interstitial, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IaluadapterDevice
minimally invasive syringe device for bladder catherization
| Study group | Role | What they receive |
|---|---|---|
| 61 patients evaluated | with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) Receives: Device: Ialuadapter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who reported success (in using syringe adapter) Yes/No
pt self reported general assessment of successful instillation using the syringe adapter
Measured: 6 months
Secondary outcomes (4)
PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options)
patient reported subjective reasons for trying the syringe adapter: options: urethral pain, convenience, fear of catheter, urine tract infections or other
Measured: 6 months
Total number of UTI's during syringe adapter use amongst all patients
Recorded UTI's reported in electronic patient database during the time they used syringe adapter
Measured: 6 months
Number of participants who use syringe adapter 3 years after initial assessment (yes/no)
long term adherence to syringe adapter (still using in in clinical practice)
Measured: 1 yr
PRO ; patient reported reasons to continue syringe adapter (5 options)
Subjective reasons given by patients for continuing with syringe adapter compared to regular catheter. Option were : hope for fewer urine tract infections, less pain, easier to use, self -sustainability, other)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Nov 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Cystitis, ChronicStudies 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
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dick Janssen, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540248
- Sponsor's protocol ID
- Ialudapter Study
- Acronym
- Ialuadapter
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2024
- Last updated
- 6 Aug 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Clinical Experience With a Minimally Invasive Syringe Adapter for Catheter Free Instillation of Intravesical Treatments
- ClinicalTrials.gov ID
- NCT06540248
- Acronym / sponsor ID
- Ialuadapter / Ialudapter Study
- Conditions
- Interstitial Cystitis, Chronic, Overactive Bladder Syndrome, Recurrent Urinary Tract Infection
- Keywords
- IALUDAPTER, intravesical therapy, GAG therapy, Intravesical treatment, IC/BPS, recurrent urine tract infection, catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 6 Aug 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.
A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.
Detailed description
Introduction Intravesical treatment is currently dependent on catheterization which can cause urethral discomfort and risk of urinary tract infections in selected patient groups such as interstitial cystitis / bladder pain syndrome (IC/BPS), overactive bladder syndrome (OAB) and recurrent urinary tract infections (rUTI). This study describes real-life clinical experience of a minimally invasive syringe adapter (Ialudapter®) for catheter-free instillation of intravesical treatment.
Methods A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 61 patients evaluated | – | Device: Ialuadapterwith IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with IC/BPS, recurrent UTIs and/or OAB * Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).
Key inclusion criteria (2 listed)
- Patients with IC/BPS, recurrent UTIs and/or OAB
- Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).
Key exclusion criteria (2 listed)
- Patients with a high post-void residue of >100ml or with an indwelling catheter were excluded from the analyses.
- Patients who cannot sign informed consent.
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 |
|---|---|---|
| Ialuadapterminimally invasive syringe device for bladder catherization | Device | 61 patients evaluated |
Primary outcome
Number of participants who reported success (in using syringe adapter) Yes/No
Time frame: 6 months
pt self reported general assessment of successful instillation using the syringe adapter
4 secondary outcomes
PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options)
Time frame: 6 months
Total number of UTI's during syringe adapter use amongst all patients
Time frame: 6 months
Number of participants who use syringe adapter 3 years after initial assessment (yes/no)
Time frame: 1 yr
PRO ; patient reported reasons to continue syringe adapter (5 options)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, Chronic and Overactive Bladder Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who reported success (in using syringe adapter) Yes/No (time frame: 6 months). 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 6 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.