Urinary Tract InfectionsINSTILMENTNCT05376670
Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
An observational study of Urinary Tract Infections and Recurrent Urinary Tract Infection, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Antimicrobial prophylactic treatment of recurrent UTI is limited by emerging resistance, antibiotic allergies and intolerances. Intravesical aminoglycoside instillations (IAI) have been shown to reduce recurrence rate, without a short-term decline in kidney function or hearing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Recurrent Urinary Tract Infection
- What is being tested?
- Intravesical aminoglycoside instillations
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Apr 2022to 7 Mar 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
- Adult, Older adult
Study population: The study population will include adult male and female patients receiving IAI for recurrent UTI at the infectious diseases outpatient clinic of the Leiden University Medical Centre. A proportion of study participants will have urological and/or neurological comorbidities and a history of other prophylactic treatments for recurrent UTI.
Who may be able to join
- Age ≥ 18 years
- Currently receiving or having received (no minimal duration) continuous or post-coital IAI (gentamicin, tobramycin or amikacin) for recurrent UTI prophylaxis and treatment
Who cannot join
- Exclusively receiving IAI for 'on-demand' treatment of UTI and not prophylactic purposes
- Receiving IAI as suppressive therapy for chronic prostatitis
- Presence of a chronic indwelling catheter
- Patient has objected to the use of his/her data
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
Antimicrobial prophylactic treatment of recurrent UTI is limited by emerging resistance, antibiotic allergies and intolerances. Intravesical aminoglycoside instillations (IAI) have been shown to reduce recurrence rate, without a short-term decline in kidney function or hearing. Thus far, treatment satisfaction has not yet been assessed, while this may play an important role in treatment adherence and persistence. Moreover, there is no data on the long-term safety of IAI, e.g. regarding the development of (pre)malignant bladder lesions.
- Being tested
- Intravesical aminoglycoside instillations
- Keywords
- Intravesical treatment
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical aminoglycoside instillationsDrug
Also called Intravesical gentamicin, tobramycin or amikacin
Overnight instillation of an aminoglycoside (CIC), varying treatment regimens
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI)
Measured with Treatment Satisfaction Questionnaire for Medication version II (TSQM-II), value ranging from 0 to 100 (with a score of 100 indicating the highest treatment satisfaction)
Measured: 1 year
Secondary outcomes (5)
Time to first UTI recurrence after initiation of IAI
Measured: First 6 months of IAI
Number of UTI recurrences
Measured: First 6 months of IAI
Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy)
Measured: First 6 months of IAI
Number of patients that wish to (dis)continue IAI
Measured: 6 months after initiation of IAI
Proportion of patients that have a UTI episode caused by the same MDRO uropathogen as before start of IAI
Measured: 6 months after initiation of IAI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start20 Apr 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manu Bilsen, MD, Leiden University Medical Center
- Investigators
- Manu Bilsen, MD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376670
- Sponsor's protocol ID
- nWMODIV2_2022013
- Acronym
- INSTILMENT
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
- ClinicalTrials.gov ID
- NCT05376670
- Acronym / sponsor ID
- INSTILMENT / nWMODIV2_2022013
- Keywords
- Intravesical treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 17 May 2022 (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.
Antimicrobial prophylactic treatment of recurrent UTI is limited by emerging resistance, antibiotic allergies and intolerances. Intravesical aminoglycoside instillations (IAI) have been shown to reduce recurrence rate, without a short-term decline in kidney function or hearing. Thus far, treatment satisfaction has not yet been assessed, while this may play an important role in treatment adherence and persistence. Moreover, there is no data on the long-term safety of IAI, e.g. regarding the development of (pre)malignant bladder lesions.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult male and female patients receiving IAI for recurrent UTI at the infectious diseases outpatient clinic of the Leiden University Medical Centre. A proportion of study participants will have urological and/or neurological comorbidities and a history of other prophylactic treatments for recurrent UTI.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Currently receiving or having received (no minimal duration) continuous or post-coital IAI (gentamicin, tobramycin or amikacin) for recurrent UTI prophylaxis and treatment
Key exclusion criteria (5 listed)
- Exclusively receiving IAI for 'on-demand' treatment of UTI and not prophylactic purposes
- Receiving IAI as suppressive therapy for chronic prostatitis
- Presence of a chronic indwelling catheter
- Patient has objected to the use of his/her data
- Inability to provide 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 |
|---|---|---|
| Intravesical aminoglycoside instillationsAlso: Intravesical gentamicin, tobramycin or amikacinOvernight instillation of an aminoglycoside (CIC), varying treatment regimens | Drug | – |
Primary outcome
Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI)
Time frame: 1 year
Measured with Treatment Satisfaction Questionnaire for Medication version II (TSQM-II), value ranging from 0 to 100 (with a score of 100 indicating the highest treatment satisfaction)
5 secondary outcomes
Time to first UTI recurrence after initiation of IAI
Time frame: First 6 months of IAI
Number of UTI recurrences
Time frame: First 6 months of IAI
Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy)
Time frame: First 6 months of IAI
Number of patients that wish to (dis)continue IAI
Time frame: 6 months after initiation of IAI
Proportion of patients that have a UTI episode caused by the same MDRO uropathogen as before start of IAI
Time frame: 6 months after initiation of IAI
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 8 Mar 2023.
- 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.
Manu Bilsen, MD principal investigator
Leiden University Medical Center
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 Urinary Tract Infections and Recurrent Urinary Tract Infection, run by Leiden 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 5 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 8 Mar 2023. 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?
Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI) (time frame: 1 year). 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 8 Mar 2023.