HappyOrNot® Smileys and the Visual Analogue Scale (VAS) in the Assessment of Urinary Symptoms

NCT07269652 | Completed

• 1 other identifier: R22025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION A simple and repeatable test would be valuable for assessing the severity and impact of urinary symptoms. Visual Analogue Scale (VAS) is a 10 cm line where a participant put a mark in place that describes best his satisfaction with woiding. VAS has been shown to correlate with flowmetry and International Prostate Symptom Score (IPSS). VAS is still a number and may not reflect participants satisfaction. HappyorNot smileys (HoN) (emoji faces) are used to measure customer satisfaction by pressing one of four emoji smilyes. Two of these are happy and two and unhappy. OBJECTIVE: \- To study the use of VAS and HoN in assessing urinary symptoms in men. MATERIALS AND METHODS:

• 100 men referred to urology outpatient clinic in Tampere University Hospital or Seinäjoki Central Hospital due to urinary symptoms caused by benign Prostate Hyperplasia (BPH)
• Participants are asked to fill VAS and HoN and results are correlated with traditional symptom questionnaires and peak urinary flow and post-void residual volume.

Conditions

Prostate Hyperplasia

Keywords

urinary symptom questionnaries; Visual analogy scale

Outcome Measures

Primary Outcomes (1)

• HappyorNot smileys and Visual Analogue Scale in the assesment of urinary symptoms

  HappyOrNot® smileys (four faces of which two represent different degrees of happyness and two different degree of unhappyness) and the Visual Analog Scale (0-10 cm, 0 cm meaning total unsatisfaction and 10 cm meanning total satisfaction) assessing urinary symptoms in men referred to the urology outpatient clinic, using traditional questionnaire as the reference. In addition, to investigate the association between HappyOrNot®/VAS results and objective measures of urinary symptom severity, such as peak urinary flow and post-void residual volume.

  From enrollment to the end of outpatient clinic visit

Study Arms (1)

VAS and NoH and urinary symptoms

EXPERIMENTAL

Participants with prostate hyperplasia

Diagnostic Test: Visual analogue scale and HappyorNot smileys

Interventions

Visual analogue scale and HappyorNot smileys DIAGNOSTIC_TEST

VAS and HoN has not been studied before

Also known as: Symptom questionnary

VAS and NoH and urinary symptoms

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all men having urinary symptoms due to prostate hyperplasia

You may not qualify if:

• not signing informed consent

Sponsors & Collaborators

• Seinajoki Central Hospital: lead
• Tampere University Hospital: collaborator

Study Sites (1)

Seinajoki Central Hospital

Seinäjoki, 60220, Finland

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mika Petri Raitanen, M.D., Ph.D., Associate Prof

  Seinajoki Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D, Associate Professor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: August 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: from March 2026 to December 2026

Locations

FI (1)