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Electronic Method for Recording Lower Urinary Tract Symptoms

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ClinicalTrials.gov Identifier: NCT02060136
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Vaclav Prochazka, MD, PhD. MSc, University Hospital Ostrava

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.


Condition or disease
Lower Urinary Tract Symptoms

Detailed Description:

SUF records the sound of the urine stream striking the water in a toilet bowl. This generates a sound file, which resembles the standard uroflowmetry recording. The degree of urgency is recorded by pressing the number 1-5 on the key pad which corresponds to the 5-point urgency scale. Urgency is recorded immediately following micturition or whenever experiencing urgency without bladder emptying. A dedicated server runs a program, which automatically processes incoming data. All data recorded from an individual is stored prospectively, in separate files, on a secure website. Each record is associated with a time stamp, providing information on urinary frequency.

A pen and pencil MC will be used to record baseline parameters (voiding urgency and frequency). Quality of life (QoL) will be evaluated using International Prostate Symptom Score (IPSS) Questionnaire, and two standardized questions: Quality of Life due to Urinary Symptoms (QoL US) and Patient Perception of Bladder Condition (PPBC).

Time frame: Participants were followed for the duration of the study which consists of two three day periods when every micturition event and lower urinary tract symptom not associated with micturition was recorded. An expected average time will be 6 days.

Twenty nine men, average age 67.8 years (range 49 - 80), which presented to the urology clinic with LUTS, were included in the study. After signing the informed consent, patients will be asked to record every micturition and degree of urgency using SUF for a period of 3 days. They will then be asked to record their frequency of micturition and the degree of every episode of urgency using a pen and paper MC for an equal length of time. The efficacy of recording LUTS with each method will be analyzed and compared. The content validity of SUF (assessment of whether the instrument makes sense to patients), will be assessed at the conclusion of the study when all patients will be interviewed one-on-one by a specialized research nurse. Patients will be asked to state their preference for one of the two diaries, and disclose the number of events they forgot to or could not record. The construct validity (relationship between the recorded data and underlying theories) will be evaluated by the correlation of symptoms recorded with SUF or MC based on QoL measures. The results of this study will be compared to previously published evidence, suggesting that more severe LUTS are associated with a lower score on the health related QoL questionnaires.


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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Validation of Electronic Recording of Lower Urinary Tract Symptoms (LUTS) in Men
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Study group
Men presenting to the urology clinic with lower urinary tract symptoms



Primary Outcome Measures :
  1. Comparison of the level of accuracy and adherence to the study protocol [ Time Frame: January - February 2014 (1 month) ]

    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.



Secondary Outcome Measures :
  1. User preference [ Time Frame: January - February (1 month) ]
    The content validity of SUF (assessment of whether the instrument makes sense to patients), will be assessed at the conclusion of the study when all patients will be interviewed one-on-one by a specialized research nurse. Patients will be asked to state their preference for one of the two diaries.



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men presenting to the urology clinic with lower urinary tract symptoms
Criteria

Inclusion Criteria:

  • Men seeking treatment for lower urinary tract symptoms

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060136


Locations
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Czech Republic
Department of Urology
Ostrava, Nothern Moravia, Czech Republic, 708 52
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Jan Krhut, MD, PhD Ostrava University

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Responsible Party: Vaclav Prochazka, MD, PhD. MSc, Chief research officer, University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02060136     History of Changes
Other Study ID Numbers: SUF LUTS
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Vaclav Prochazka, MD, PhD. MSc, University Hospital Ostrava:
Electronic micturition chart, validation

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms