Lower Urinary Tract SymptomsNCT02060136
Electronic Method for Recording Lower Urinary Tract Symptoms
An observational study of Lower Urinary Tract Symptoms, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 29 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men presenting to the urology clinic with lower urinary tract symptoms
Who may be able to join
- Men seeking treatment for lower urinary tract symptoms
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Electronic Recording of Lower Urinary Tract Symptoms (LUTS) in Men
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.
Read the 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.
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Electronic micturition chart, validation
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Men presenting to the urology clinic with lower urinary tract symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January - February 2014 (1 month)
Secondary outcomes (1)
User preference
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.
Measured: January - February (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaclav Prochazka, MD, PhD. MSc, University Hospital Ostrava
- Investigators
- Jan Krhut, MD, PhD, Principal investigator, Ostrava University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060136
- Sponsor's protocol ID
- SUF LUTS
- Status last verified
- Feb 2014
- First submitted
- 27 Jan 2014
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Electronic Recording of Lower Urinary Tract Symptoms (LUTS) in Men
- ClinicalTrials.gov ID
- NCT02060136
- Acronym / sponsor ID
- SUF LUTS
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Electronic micturition chart, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Men presenting to the urology clinic with lower urinary tract symptoms |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men presenting to the urology clinic with lower urinary tract symptoms
Key inclusion criteria (1 listed)
- Men seeking treatment for lower urinary tract symptoms
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
User preference
Time frame: January - February (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Krhut, MD, PhD principal investigator
Ostrava University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the level of accuracy and adherence to the study protocol (time frame: January - February 2014 (1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.