Comparison of Self-administered IPSS, Sanitary Staff-supervised IPSS, Medical History and Clinical Parameters
NCT ID: NCT03603821
Last Updated: 2018-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2017-05-24
2019-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LUTS male
Clinical assesment of males older than 50 years with lower urinary tract symptoms presumably related to benign prostate enlargement
CLINICAL ASSESMENT
IPSS questionnaire, uroflowmetry, prostate and bladder ultrasonography, voiding diary, medical interview
Interventions
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CLINICAL ASSESMENT
IPSS questionnaire, uroflowmetry, prostate and bladder ultrasonography, voiding diary, medical interview
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Bladder tumor o lithiasis
* changes in LUTS treatment during the analysis period (pharmacological or surgical)
* urethral manipulation during the analysis period (catheterization or cystoscopy)
50 Years
MALE
No
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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EDUARDO VICENTE PALACIO
Senior and Consultor Staff in the Department of Urology
Principal Investigators
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EDUARDO VICENTE PALACIO, UROLOGIST
Role: STUDY_DIRECTOR
CORPORATION PARC TAULI
Locations
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Corporacion Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Kill IPSS
Identifier Type: -
Identifier Source: org_study_id
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