Overactive Bladder Syndrome (OAB) / Overactive Bladder
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5.1 Study parameters/endpoints Divided in three parts in accordance with the study objectives. 5.1.1 Part I Comparison of the ESM vs. SR-BDs Main study parameter/endpoint • Urgency scores as measured by two self-report measures: - The ESM tool (i.e. momentary measurement) - The sensation-related bladder diary (i.e. retrospective measurement with a recall period of several minutes) 5.1.2 Part II Validation Main study parameter/endpoint • Urgency scores as measured by two self-report measures: - The ESM tool (i.e. momentary measurement) - The sensation-related bladder diary (i.e. retrospective measurement with a recall period of several minutes) | — |
Secondary
| Measure | Time frame |
|---|---|
| 5.1 Study parameters/endpoints Divided in three parts in accordance with the study objectives. 5.1.1 Part I Comparison of the ESM vs. SR-BDs Secondary study parameters/endpoints (if applicable) • Symptom scores (other than urgency) as measured using the ESM tool: - Micturition habits, i.e. number of micturitions each day and the force of the urinary stream using the Visual Prostate Symptom Score (VPSS) • Symptom scores (other than urgency) as measured using the single-time retrospective questionnaires: - Urological symptoms: • Female participants: OABq, ICIQ-FLUTS, 3IQ • Male participants: OABq, ICIQ-MLUTS, 3 IQ, IPSS, IIEF-5 5.1.2 Part II Validation Secondary study parameters/endpoints (if applicable) • Symptom scores (other than urgency) as measured using the ESM tool: - Micturition habits, i.e. number of micturitions each day and the force of the urinary stream using the Visual Prostate Symptom Score (VPSS) - Gastrointestinal symptoms - Psychological symptoms - Gynaecological symptoms - Extra-intestinal somatic symptoms - Data on context and environment at each time an ESM questionnaire is completed • Symptom scores (other than urgency) as measured using the sensation-related bladder diary: - Micturition habits, i.e. number of micturitions each day • Symptom scores (other than urgency) as measured using the single-time retrospective questionnaires: - Urological symptoms: • Female participants: OABq, ICIQ-FLUTS, 3IQ • Male participants: OABq, ICIQ-MLUTS, 3 IQ, IPSS, IIEF-5 - Psychological symptoms: HADS - Gynaecological symptoms : Questionnaire Werkgroep Bekkenbodem NVOG - Extra-intestinal symptoms and Quality of Life scores: SF-36 | — |
Countries
Netherlands
Outcome results
None listed