Lower Urinary Tract SymptomsKILLNCT03603821
Comparison of Self-administered IPSS, Sanitary Staff-supervised IPSS, Medical History and Clinical Parameters
An observational study of Lower Urinary Tract Symptoms, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Descriptive prospective study carried out to compare the results obtained by self-administered IPSS (International Prostate Symptom Score), Sanitary staff-supervised IPSS and directed medical interview and its correlation with clinical parameters in the assessment of lower urinary tract symptoms in males. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- CLINICAL ASSESMENT
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 24 May 2017to 1 Dec 2019
- How long will I take part?
- 1 Month
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males older than 50 years with low urinary symptoms followed in the investigator's Urology outpatient clinic
Who may be able to join
- males older than 50 years, with LUTS
Who cannot join
- Urinary tract infection
- Bladder tumor o lithiasis
- changes in LUTS treatment during the analysis period (pharmacological or surgical)
- urethral manipulation during the analysis period (catheterization or cystoscopy)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Corporacion Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
EDUARDO VICENTE PALACIO, UROLOGIST, (34) 937231010 ext. 29216, 26864evp@comb.cat
About this study
Official title: Quantitative Comparison of Results Obtained by Self-administered IPSS, Sanitary Staff-supervised IPSS and Directed Medical History and Its Correlation With Clinical Parameters in the Assessment of Lower Urinary Tract Symptoms in Males
Descriptive prospective study carried out to compare the results obtained by self-administered IPSS (International Prostate Symptom Score), Sanitary staff-supervised IPSS and directed medical interview and its correlation with clinical parameters in the assessment of lower urinary tract symptoms in males.
Read the detailed description
The IPSS is a validated questionnaire (also in spanish language) widely used to evaluate lower urinary tract symptoms (LUTS) in males. It contains 7 multiple-choice questions related to urinary symptoms with a Likert response scale and 1 question assessing quality of life. This test has been approved for self-administration and its purpose is quantifying and monitoring symptoms severity.
The aim of this study is to compare the scores achieved in a self-administered IPSS questionnaire with those obtained when the questionnaire is answered with the help and supervision of a sanitary staff. These results will also be contrasted with the scores retrieved in a standard directed medical interview and correlated with objective functional parameters of lower urinary tract symptoms.
A descriptive prospective study will be carried out analysing lower urinary tract symptoms from patients over 50 years old.
All patients will be provided with a IPSS to be fulfilled at home and after a short period of time without any change in his LUTS treatment, the patient will repeat the questionnaire in the hospital under the supervision of a sanitary staff.
A standard structured medical interview focusing in LUTS will be performed to every patient. In order to compare the results achieved with both IPSS with those obtained during the interview a Likert score was assigned to each question.
At the same time, objective lower urinary tract symptoms data will be collected and compared to the results obtained previously with both the questionnaires and the medical interview. Uroflowmetry and post physiological void residual volume measurement with ultrasonography will be performed as evaluation of voiding symptoms. On the other hand, filling symptoms will be evaluated with a validated 3-day voiding diary to be accomplished previously to the medical visit.
Data to be collected includes Uroflowmetry parameters Qmax, Qm, curve shape type and time to Qmax, ultrasonographic PVR (post-void residual) measurement and daytime and nightime number of voids, medium volume of void, number of urgency and urge incontinence episodes and maximal vesical functional volume wich will be extracted from the 3-day voiding diary.
A statistical analysis will be performed to compare the scores obtained through the questionnaires and the medical interview and the correlation of each of them with the objective clinical parameters obtained.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- CLINICAL ASSESMENT
- Keywords
- LUTS, QUESTIONNAIRE, IPSS
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLINICAL ASSESMENTDiagnostic test
Also called Ultrasonography, IPSS questionnaire, Voiding diary, Uroflowmetry
IPSS questionnaire, uroflowmetry, prostate and bladder ultrasonography, voiding diary, medical interview
| Study group | Role | What they receive |
|---|---|---|
| LUTS male | Clinical assesment of males older than 50 years with lower urinary tract symptoms presumably related to benign prostate enlargement Receives: Diagnostic Test: CLINICAL ASSESMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between different clinical severity scores in LUTS
correlation between the scores obtained with an self-administered IPSS, a sanitary staff-supervised IPSS and a standard medical interview focused on LUTS based on a Likert severity scale 0-4 (5 levels of severity)
Measured: data will be measured once all questionnaires are provided and objective explorations performed. All data will be obtained in a maximum of 30 days period for each patient. During this period of time the patient will not change any of his treatments.
Secondary outcomes (1)
correlation between clinical severity scores and objective severity symptoms
correlation between the scores obtained with IPSS (self-administered and nurse-supervised and a standard medical interview with different objective clinical parameters of storage and voiding symptoms
Measured: data will be measured once all questionnaires are provided and objective explorations performed. All data will be obtained in a maximum of 30 days period for each patient. During this period of time the patient will not change any of his treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start24 May 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
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.
- 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
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDUARDO VICENTE PALACIO, Corporacion Parc Tauli
- Investigators
- EDUARDO VICENTE PALACIO, UROLOGIST, Study director, CORPORATION PARC TAULI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603821
- Sponsor's protocol ID
- Kill IPSS
- Acronym
- KILL
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Comparison of Results Obtained by Self-administered IPSS, Sanitary Staff-supervised IPSS and Directed Medical History and Its Correlation With Clinical Parameters in the Assessment of Lower Urinary Tract Symptoms in Males
- ClinicalTrials.gov ID
- NCT03603821
- Acronym / sponsor ID
- KILL / Kill IPSS
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- LUTS, QUESTIONNAIRE, IPSS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 27 Jul 2018 (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.
Descriptive prospective study carried out to compare the results obtained by self-administered IPSS (International Prostate Symptom Score), Sanitary staff-supervised IPSS and directed medical interview and its correlation with clinical parameters in the assessment of lower urinary tract symptoms in males.
Detailed description
The IPSS is a validated questionnaire (also in spanish language) widely used to evaluate lower urinary tract symptoms (LUTS) in males. It contains 7 multiple-choice questions related to urinary symptoms with a Likert response scale and 1 question assessing quality of life. This test has been approved for self-administration and its purpose is quantifying and monitoring symptoms severity.
The aim of this study is to compare the scores achieved in a self-administered IPSS questionnaire with those obtained when the questionnaire is answered with the help and supervision of a sanitary staff. These results will also be contrasted with the scores retrieved in a standard directed medical interview and correlated with objective functional parameters of lower urinary tract symptoms.
A descriptive prospective study will be carried out analysing lower urinary tract symptoms from patients over 50 years old.
All patients will be provided with a IPSS to be fulfilled at home and after a short period of time without any change in his LUTS treatment, the patient will repeat the questionnaire in the hospital under the supervision of a sanitary staff.
A standard structured medical interview focusing in LUTS will be performed to every patient. In order to compare the results achieved with both IPSS with those obtained during the interview a Likert score was assigned to each question.
At the same time, objective lower urinary tract symptoms data will be collected and compared to the results obtained previously with both the questionnaires and the medical interview. Uroflowmetry and post physiological void residual volume measurement with ultrasonography will be performed as evaluation of voiding symptoms. On the other hand, filling symptoms will be evaluated with a validated 3-day voiding diary to be accomplished previously to the medical visit.
Data to be collected includes Uroflowmetry parameters Qmax, Qm, curve shape type and time to Qmax, ultrasonographic PVR (post-void residual) measurement and daytime and nightime number of voids, medium volume of void, number of urgency and urge incontinence episodes and maximal vesical functional volume wich will be extracted from the 3-day voiding diary.
A statistical analysis will be performed to compare the scores obtained through the questionnaires and the medical interview and the correlation of each of them with the objective clinical parameters obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUTS male | – | Diagnostic Test: CLINICAL ASSESMENTClinical assesment of males older than 50 years with lower urinary tract symptoms presumably related to benign prostate enlargement |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males older than 50 years with low urinary symptoms followed in the investigator's Urology outpatient clinic
Key inclusion criteria (1 listed)
- males older than 50 years, with LUTS
Key exclusion criteria (4 listed)
- Urinary tract infection
- Bladder tumor o lithiasis
- changes in LUTS treatment during the analysis period (pharmacological or surgical)
- urethral manipulation during the analysis period (catheterization or cystoscopy)
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 |
|---|---|---|
| CLINICAL ASSESMENTAlso: Ultrasonography, IPSS questionnaire, Voiding diary, UroflowmetryIPSS questionnaire, uroflowmetry, prostate and bladder ultrasonography, voiding diary, medical interview | Diagnostic test | LUTS male |
Primary outcome
correlation between different clinical severity scores in LUTS
Time frame: data will be measured once all questionnaires are provided and objective explorations performed. All data will be obtained in a maximum of 30 days period for each patient. During this period of time the patient will not change any of his treatments.
correlation between the scores obtained with an self-administered IPSS, a sanitary staff-supervised IPSS and a standard medical interview focused on LUTS based on a Likert severity scale 0-4 (5 levels of severity)
1 secondary outcome
correlation between clinical severity scores and objective severity symptoms
Time frame: data will be measured once all questionnaires are provided and objective explorations performed. All data will be obtained in a maximum of 30 days period for each patient. During this period of time the patient will not change any of his treatments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: Yes
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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.
EDUARDO VICENTE PALACIO, UROLOGIST study director
CORPORATION PARC TAULI
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 Lower Urinary Tract Symptoms, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2018. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EDUARDO VICENTE PALACIO, UROLOGIST ((34) 937231010 ext. 29216, 26864evp@comb.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between different clinical severity scores in LUTS (time frame: data will be measured once all questionnaires are provided and objective explorations performed. All data will be obtained in a maximum of 30 days period for each patient. During this period of time the patient will not change any of his treatments.). 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 30 Jul 2018.