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

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.

Study Overview

• Status: Unknown
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Diagnostic test: CLINICAL ASSESMENT

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Corporacion Sanitaria Parc Tauli
      • Contact: EDUARDO VICENTE PALACIO, UROLOGIST; Phone Number: 29216 (34) 937231010; Email: 26864evp@comb.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; IPSS questionnaire, uroflowmetry, prostate and bladder ultrasonography, voiding diary, medical interview; Other Names: Ultrasonography; IPSS questionnaire; Voiding diary; Uroflowmetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Study Director: EDUARDO VICENTE PALACIO, UROLOGIST, CORPORATION PARC TAULI

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: IPSS; LUTS; QUESTIONNAIRE
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: Kill IPSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No