Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02060136
Other study ID # SUF LUTS
Secondary ID
Status Completed
Phase N/A
First received January 27, 2014
Last updated February 10, 2014
Start date June 2013
Est. completion date January 2014

Study information

Verified date February 2014
Source University Hospital Ostrava
Contact n/a
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug ControlCzech Republic: Ethics Committee
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 90 Years
Eligibility Inclusion Criteria:

- Men seeking treatment for lower urinary tract symptoms

Exclusion Criteria:

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Czech Republic Department of Urology Ostrava Nothern Moravia

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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. January - February (1 month) No
See also
  Status Clinical Trial Phase
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Enrolling by invitation NCT06317116 - Examining the Relationship Between Core Muscles and Bladder Issues in Children
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Recruiting NCT05814614 - Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation N/A
Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT06452927 - EEP in Patients With Urodynamically Proven DU/DA N/A
Completed NCT03339609 - Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children N/A
Completed NCT02330107 - Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men N/A
Terminated NCT02003742 - Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH Phase 3
Terminated NCT01003249 - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen Phase 4
Completed NCT01078545 - Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS) N/A
Completed NCT02074644 - Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia N/A
Recruiting NCT03802851 - HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT05702294 - Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries . N/A
Enrolling by invitation NCT05537272 - The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy Phase 4
Recruiting NCT05826691 - Benign Prostate Surgery and QOL and Sexual Function
Completed NCT04104100 - Prevalence and Risk Factor of NP in Women With LUTS
Completed NCT04190641 - Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder N/A