*The Experience Sampling Method (ESM): a real-time Patient-Reported Outcome Measure for symptom assessment in patients with overactive bladder syndrome.*
- Conditions
- Overactive Bladder Syndrome (OAB) / Overactive Bladder10046590
- Registration Number
- NL-OMON55620
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
Patients between 18-70 years with either subjectively experienced OAB for which
they have sought medical help or have been diagnosed with OAB by a medical
physician. Participants need to be able to understand written Dutch and speak
the Dutch language, since the ESM app will be conducted in Dutch. They also
have to understand how to practice the ESM tool., Healthy volunteers:
• Age between 18 and 70 years;
• Male and female
• Ability to understand and speak Dutch;
• Ability to understand how to utilize the ESM tool.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Patients with a clear anatomical or other urological cause for OAB (e.g.
bladder cancer, benign prostate hyperplasia (BPH), prostate cancer,
urolithiasis, chronic or acute urinary tract infections (UTI), neurological
disease).
• Patient with severe stress incontinence
• Pregnancy , Healthy volunteers:
• Current or past diagnosis of lower urinary tract symptoms;
• No more than one urinary tract infection in half a year.
• Start-up of regularly used medication from one month before inclusion until
the end of study participation.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>5.1 Study parameters/endpoints<br /><br>Divided in three parts in accordance with the study objectives.<br /><br><br /><br>5.1.1 Part I Comparison of the ESM vs. SR-BDs<br /><br>Main study parameter/endpoint<br /><br>• Urgency scores as measured by two self-report measures:<br /><br>- The ESM tool (i.e. momentary measurement)<br /><br>- The sensation-related bladder diary (i.e. retrospective measurement with a<br /><br>recall period of several minutes)<br /><br><br /><br>5.1.2 Part II Validation<br /><br>Main study parameter/endpoint<br /><br>• Urgency scores as measured by two self-report measures:<br /><br>- The ESM tool (i.e. momentary measurement)<br /><br>- The sensation-related bladder diary (i.e. retrospective measurement with a<br /><br>recall period of several minutes)</p><br>
- Secondary Outcome Measures
Name Time Method