Experience Sampling Method in OAB Patients

NCT03435991 | Unknown

• 1 other identifier: NL63006.068.17
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The overactive bladder syndrome is diagnosed clinically by using the ICS criteria of ≥8 micturitions and at least 1 urgency episode per 24 hours. To determine whether patients fit the criteria, micturition diaries ('sensation-related bladder diaries') and other symptom questionnaires with considerable limitations are used. This makes it difficult to get a good impression of the fluctuation of complaints during the day / week. These limitations are overcome using the Experience Sampling Method (ESM). This is an electronic questioning method which is characterized by repeated and random, momentary assessments in the subject's current environment and state. This study follows other successful ESM studies done within the Gastroenterology and Psychiatry Department. The aim of this study is to evaluate if the ESM is more accurate in the assessment of urological complaints in OAB compared to the current assessment with the use of the sensations-related bladder diaries (SR-BDs) and retrospective questionnaires. Furthermore the aim is to assess the reliability and validity of this OAB-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and assessment of triggers for symptoms in OAB. Objective: To evaluate the accuracy of the ESM to assess urological complaints in OAB compared to SR-BDs and retrospective questionnaires. To assess content validity, reliability and the accuracy to validate the developed ePRO in OAB patients. Study design: The ESM study is a multicentre, prospective, cross-sectional study. Study population: 66 OAB patients will be recruited at the outpatient Pelvic Care Centre in Maastricht UMC+, Zuyderland Hospital and University Hospital Antwerp, 66 healthy volunteers will be recruited as well. Methods: In a period of 7 days, participants will fill out an electronic ESM assessment at 10 random moments during the day. Moreover, they will fill out a sensation-related bladder diary (SR-BD) during the last three consecutive days of filling out the ESM and several symptom questionnaires at the end of the study period. Main study endpoints: The main study outcome comprehends the psychometric properties of the PROM for symptom assessment of OAB symptoms. Secondary outcomes are increase in ESM score for OAB symptoms and environmental and psychosocial factors (e.g. as measured by the PROM) from one time point (t-1) to the next (t).

Conditions

Overactive Bladder; Overactive Bladder Syndrome

Keywords

Experience Sampling Method; Ecological Momentary Assessment; Momentary Symptom Assessment; Patient Reported Outcome Measure

Outcome Measures

Primary Outcomes (2)

• Urgency (ESM score)

  Urgency scores as measured by the Experience Sampling Method tool (i.e. momentary measurement)

  2 years

• Urgency (SR-BD score)

  Urgency scores as measured by the sensation-related bladder diary (i.e. retrospective measurement with a recall period of several minutes)

  2 years

Secondary Outcomes (7)

• Symptom scores (other than urgency) as measured using the ESM tool

  2 years

• OABq symptom score

  2 years

• ICIQ-FLUTS symptom score

  2 years

• 3IQ symptom score

  2 years

• ICIQ-MLUTS symptom score

  2 years

Study Arms (2)

OAB patients

Other: Validation Experience Sampling Method 'Uromate'

Healthy volunteers

Other: Validation Experience Sampling Method 'Uromate'

Interventions

Validation Experience Sampling Method 'Uromate' OTHER

In a period of 7 days, participants will fill out an electronic ESM assessment at 10 random moments during the day. Moreover, they will fill out a sensation-related bladder diary (SR-BD) during the last three consecutive days of filling out the ESM and several symptom questionnaires at the end of the study period.

Healthy volunteers; OAB patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty-three male and thirty-three female OAB patients will be recruited at the outpatient Pelvic Care Centre in Maastricht UMC+ and at the outpatient clinic of Zuyderland Hospital and University Hospital Antwerp. Patients will be diagnosed with OAB by their urologist using the ICS criteria for OAB. Furthermore, thirty-five male and thirty-five female healthy volunteers will be included in order to exploratively evaluate the ability of ESM to discriminate between OAB patients and healthy controls, in terms of triggers for the occurrence and/or persistence of urological symptoms. This control group will be sex- and age-matched to the group of OAB patients.

You may qualify if:

• Age between 18 and 70 years;
• Male and female
• Ability to understand and speak Dutch;
• Ability to understand how to utilize the ESM tool.

You may not qualify if:

• 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
• Current or past diagnosis of lower urinary tract symptoms;
• No more than one urinary tract infection in half a year.
• Pregnancy

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Zuyderland Hospital: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (1)

Maastricht Univeristy Medical Center+

Maastricht, Netherlands

RECRUITING

Related Publications (29)

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• Broen MP, Marsman VA, Kuijf ML, Van Oostenbrugge RJ, van Os J, Leentjens AF. Unraveling the Relationship between Motor Symptoms, Affective States and Contextual Factors in Parkinson's Disease: A Feasibility Study of the Experience Sampling Method. PLoS One. 2016 Mar 10;11(3):e0151195. doi: 10.1371/journal.pone.0151195. eCollection 2016.

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MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Desiree Vrijens, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Herrewegh, MD

CONTACT

+31(0)43 387 7259; alexandra.herrewegh@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 19, 2018
• Study Start: August 6, 2018
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

NL (1)