Electronic Method for Recording Lower Urinary Tract Symptoms

NCT02060136 | Completed

• 1 other identifier: SUF LUTS
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary diaries have proven to be beneficial in assessing lower urinary tract symptoms (LUTS), however they have not achieved widespread acceptance. The likely reason is the fact that the pen and paper diaries are labor intensive for both patient (need to carry a pen and paper and record each event) and doctor (need to transfer, summarize and analyze the data). Hypothesis: Electronic voiding diary, would automate the recording and analysis of data, expedite the process, improve its accuracy and cost effectiveness. Electronic recording of lower urinary tract symptoms (SUF) uses wireless phone and web based technologies to record LUTS remotely and store the data on a secure website which can be accessed by the doctor or patient whenever needed. The goal of this study was to compare its validity and reliability to the traditional micturition chart (MC) recording method - the current gold standard where the patient records the time of micturition and degree of urgency using a pen and paper.

Conditions

Lower Urinary Tract Symptoms

Keywords

Electronic micturition chart, validation

Outcome Measures

Primary Outcomes (1)

• Comparison of the level of accuracy and adherence to the study protocol

  Asses a difference between average number of micturition events, frequency, and degree of urgency episodes recorded using SUF and MC, to determine is SUF provides equally relevant information to that obtained by the standard approach. User compliance will be assessed though recording the number of patients who forgot to record micturitions and urgency episodes using SUF versus MC.

  January - February 2014 (1 month)

Secondary Outcomes (1)

• User preference

  January - February (1 month)

Study Arms (1)

Study group

Men presenting to the urology clinic with lower urinary tract symptoms

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men presenting to the urology clinic with lower urinary tract symptoms

You may qualify if:

• Men seeking treatment for lower urinary tract symptoms

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

Department of Urology

Ostrava, Nothern Moravia, 708 52, Czechia

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Krhut, MD, PhD

  Ostrava University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief research officer

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: February 11, 2014
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

CZ (1)