Electronic Method for Recording Lower Urinary Tract Symptoms
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

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.
    

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.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men presenting to the urology clinic with lower urinary tract symptoms
      
Keywords: Electronic micturition chart, validation