Lower Urinary Tract Symptoms Clinical Trial
— KILLOfficial 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
NCT number | NCT03603821 |
Other study ID # | Kill IPSS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 24, 2017 |
Est. completion date | December 1, 2019 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - males older than 50 years, with LUTS Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Spain | Corporacion Sanitaria Parc Tauli | Sabadell | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Corporacion Parc Tauli |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 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 | 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 | 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. |
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