Comparison of Self-administered IPSS, Sanitary Staff-supervised IPSS, Medical History and Clinical Parameters

NCT03603821 | Unknown

• 1 other identifier: Kill IPSS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Urinary Tract Symptoms

Keywords

LUTS; QUESTIONNAIRE; IPSS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• correlation between clinical severity scores and objective severity 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.

Study Arms (1)

LUTS male

Clinical assesment of males older than 50 years with lower urinary tract symptoms presumably related to benign prostate enlargement

Diagnostic Test: CLINICAL ASSESMENT

Interventions

CLINICAL ASSESMENT DIAGNOSTIC_TEST

IPSS questionnaire, uroflowmetry, prostate and bladder ultrasonography, voiding diary, medical interview

Also known as: Ultrasonography, IPSS questionnaire, Voiding diary, Uroflowmetry

LUTS male

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males older than 50 years with low urinary symptoms followed in the investigator's Urology outpatient clinic

You may qualify if:

• males older than 50 years, with LUTS

You may not qualify if:

• 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)

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporacion Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• EDUARDO VICENTE PALACIO, UROLOGIST

  CORPORATION PARC TAULI

  STUDY DIRECTOR

Central Study Contacts

EDUARDO VICENTE PALACIO, UROLOGIST

CONTACT

(34) 937231010; 26864evp@comb.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior and Consultor Staff in the Department of Urology

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 27, 2018
• Study Start: May 24, 2017
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)