Lower Urinary Tract SymptomsNCT04622215
Diuresis, Functional Bladder Capacity and LUTS in CKD and ESRD Patients.
A study testing ICIQ questionnaire in people with Lower Urinary Tract Symptoms and End Stage Renal Disease, run by Universitair Ziekenhuis Brussel at 3 sites in Belgium.
Trial summary
The aim of the study is to evaluate the prevalence of LUTS in patients with moderate to severe (Stage IIIb), severe (Stage IV) CKD and ESRD : Stage V CKD) without renal transplantation (both pre-dialysis and dialysis patients). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms, End Stage Renal Disease
- What is being tested?
- ICIQ questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Jan 2019to 1 Jul 2019
- Phase
- Interventional
- 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
Who may be able to join
- >18years old
- GFR(CKD-Epi) < 45 ml/min and persisting minimal diuresis
- able to read and understand Dutch, French or English
Who cannot join
- <18 years old
- eGFR (CKD-EPI) > 45 ml/min
- eGFR (CKD-EPI) < 45 ml/min and > 3 months absent persisting minimal diuresis
- unable to read and understand Dutch, French or English
- renal transplant recipients.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Valida
Brussels, Brussels Capital, 1082
universitair ziekenhuis VUB
Jette, Vlaams Brabant, 1090
AZ Jan Portaels
Vilvoorde, Vlaams Brabant, 1800
About this study
Official title: Diuresis, Functional Bladder Capacity and LUTS (Lower Urinary Tract Symptoms) in CKD (Chronic Kidney Disease) and ESRD (End Stage Renal Disease) Patients.
The aim of the study is to evaluate the prevalence of LUTS in patients with moderate to severe (Stage IIIb), severe (Stage IV) CKD and ESRD : Stage V CKD) without renal transplantation (both pre-dialysis and dialysis patients). The study will also investigate the correlation between the diuresis, functional bladder capacity and LUTS in this population.
By means of the obtained results, the investigators hope to be able to predict at which values of diuresis and functional bladder capacity these patients will start to develop LUTS. The investigators will also evaluate the impact of LUTS on the quality of life of these patients.
Read the detailed description
Pre-dialysis and peritoneal dialysis (home dialysis) and hemodialysis patients will be asked to fill in a 24h voiding diary the day prior to the control visit or dialysis session, or this can be registered the day of planned 24h urine collection.
All patients will be asked to fill a ICIQ-LUTS questionnaire. The ICIQ-LUTS questionnaire is a validated questionnaire to investigate the presence of LUTS in a non-invasive way: ICIQ-FLUTS(female lower urinary tract symptoms) for female patients and ICIQ-MLUTS(male lower urinary tract symptoms) for male patients.
Following patient data will be registered:
- Age
- Gender
- eGFR(estimated Glomerular Filtration Rate) (CKD-EPD)
- Cause of CKD-ESRD
- In case of dialysis: duration modality (hemodialysis or peritoneal dialysis)
- Antecedents
- Comorbidities
- Medication
- 24h voiding diary
- LUTS questionnaire
- Being tested
- ICIQ questionnaire
- Keywords
- Lower Urinary Tract Symptoms, End Stage Renal Disease
- Medical subject headings
- Lower Urinary Tract Symptoms, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICIQ questionnaireDiagnostic test
questionnaire
| Study group | Role | What they receive |
|---|---|---|
| ICIQ questionnaire | Other | Not described Receives: Diagnostic Test: ICIQ questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of LUTS in ESRD by ICIQ questionnaire
A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.
Measured: up to 6 month
Secondary outcomes (1)
evaluation of bladder capacity in ESRD
Patient will be asked to keep an 24hour voiding diary This consist in keeping a record of the time of voiding and the volume of urine passed in ml each void. This will be measured in milliliter
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Jan 2019
- Primary completion31 May 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- veerle de boe, md, Principal investigator, universitair ziekenhuis VUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622215
- Sponsor's protocol ID
- 2018-284
- Status last verified
- Oct 2018
- First submitted
- 5 Dec 2018
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuresis, Functional Bladder Capacity and LUTS (Lower Urinary Tract Symptoms) in CKD (Chronic Kidney Disease) and ESRD (End Stage Renal Disease) Patients.
- ClinicalTrials.gov ID
- NCT04622215
- Acronym / sponsor ID
- 2018-284
- Keywords
- Lower Urinary Tract Symptoms, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 9 Nov 2020 (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.
The aim of the study is to evaluate the prevalence of LUTS in patients with moderate to severe (Stage IIIb), severe (Stage IV) CKD and ESRD : Stage V CKD) without renal transplantation (both pre-dialysis and dialysis patients). The study will also investigate the correlation between the diuresis, functional bladder capacity and LUTS in this population.
By means of the obtained results, the investigators hope to be able to predict at which values of diuresis and functional bladder capacity these patients will start to develop LUTS. The investigators will also evaluate the impact of LUTS on the quality of life of these patients.
Detailed description
Pre-dialysis and peritoneal dialysis (home dialysis) and hemodialysis patients will be asked to fill in a 24h voiding diary the day prior to the control visit or dialysis session, or this can be registered the day of planned 24h urine collection.
All patients will be asked to fill a ICIQ-LUTS questionnaire. The ICIQ-LUTS questionnaire is a validated questionnaire to investigate the presence of LUTS in a non-invasive way: ICIQ-FLUTS(female lower urinary tract symptoms) for female patients and ICIQ-MLUTS(male lower urinary tract symptoms) for male patients.
Following patient data will be registered:
- Age
- Gender
- eGFR(estimated Glomerular Filtration Rate) (CKD-EPD)
- Cause of CKD-ESRD
- In case of dialysis: duration modality (hemodialysis or peritoneal dialysis)
- Antecedents
- Comorbidities
- Medication
- 24h voiding diary
- LUTS questionnaire
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICIQ questionnaire | Other | Diagnostic Test: ICIQ questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18years old
- GFR(CKD-Epi) < 45 ml/min and persisting minimal diuresis
- able to read and understand Dutch, French or English
Key exclusion criteria (5 listed)
- <18 years old
- eGFR (CKD-EPI) > 45 ml/min
- eGFR (CKD-EPI) < 45 ml/min and > 3 months absent persisting minimal diuresis
- unable to read and understand Dutch, French or English
- renal transplant recipients.
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 |
|---|---|---|
| ICIQ questionnairequestionnaire | Diagnostic test | ICIQ questionnaire |
Primary outcome
prevalence of LUTS in ESRD by ICIQ questionnaire
Time frame: up to 6 month
A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.
1 secondary outcome
evaluation of bladder capacity in ESRD
Time frame: up to 6 month
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 16 Nov 2020.
Related trials for Lower Urinary Tract Symptoms
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruitingPhase 1
RT-310 Dose Escalation BPH Study
BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
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.
veerle de boe, md principal investigator
universitair ziekenhuis VUB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICIQ questionnaire in people with Lower Urinary Tract Symptoms and End Stage Renal Disease, run by Universitair Ziekenhuis Brussel at 3 sites in Belgium.
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 3 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
prevalence of LUTS in ESRD by ICIQ questionnaire (time frame: up to 6 month). 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 16 Nov 2020.