Overactive BladderNCT03435991
Experience Sampling Method in OAB Patients
An observational study of Overactive Bladder and Overactive Bladder Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome
- What is being tested?
- Validation Experience Sampling Method 'Uromate'
- How many people
- 132 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Aug 2018to 5 Jan 2021
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age between 18 and 70 years;
- Male and female
- Ability to understand and speak Dutch;
- Ability to understand how to utilize the ESM tool.
Who cannot join
- 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.
- Start-up of regularly used medication from one month before inclusion until the end of study participation.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht Univeristy Medical Center+
Maastricht
Alexandra Herrewegh, MD, +31433877262, alexandra.herrewegh@mumc.nl
About this study
Official title: 'The Experience Sampling Method (ESM): a Real-time Patient-Reported Outcome Measure for Symptom Assessment in Patients With Overactive Bladder Syndrome.'
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.
Read more
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).
Read the detailed description
The overactive bladder syndrome (OAB) is defined by the International Continence Society (ICS) as a symptom complex of urgency, usually with frequency and nocturia (awakening at night to void), with (OAB wet) or without (OAB dry) urinary urgency incontinence. Urgency is the complaint of a sudden compelling desire to pass urine, which is difficult to defer. OAB is clinically diagnosed using the ICS criteria of ≥8 micturitions and at least 1 urgency episode per 24 hours.
It is estimated that approximately 16-17% of the adult population of the Western world is affected by OAB. The incidence of OAB, both wet and dry increases by age, and because of the worldwide ageing of the population, the number of adults affected by urinary urgency incontinence (UUI) would increase. The health care costs of OAB are high, and work productivity can be significantly impacted as well. In addition, OAB can be associated with comorbidity and increased mortality. Furthermore, OAB with and without incontinence has been associated with significantly lower quality of life scores compared to matched controls without voiding complaints. It is of particular interest that OAB does not only affect the patients, but also has an impact on family members.
There is a strong association between OAB and psychiatric comorbidities such as depression, anxiety and stress. This association is most likely bidirectional.
The current methods of diagnosis rely on voiding diaries (the sensation-related bladder diary) and retrospective questionnaires.
Retrospective, self-reported outcomes have important limitations. Firstly, there is a high risk for recall bias, in which retrospective information consists of a reconstruction of a few specific moments rather than a reliable reflection of symptoms over a predefined period of time. Furthermore, it is well described that memory retrieval is influenced by the individual's environment and mental state at the time of recall, known as ecological bias. In conclusion, patient experiences about symptoms in the past can be significantly distorted when retrospectively reported. Furthermore, lack of patient compliance is an important disturbing factor in recalled assessments. Studies that employed paper diaries in a population of patients with chronic somatic pain to measure symptoms resulted in very low patient compliance: only 11% actual compliance, but up to 80% fake compliance was determined, the latter presumably resulting from filling in diaries after the proscribed time window.
The Experience Sampling Method (ESM), also referred to as Ecological Momentary Assessment (EMA), may overcome these limitations. ESM is an electronic questioning method characterized by random, repeated assessments in the subject's current state and environment, for several consecutive days. A digital device sends out an auditory beep at random moments during the day, to which subjects have to respond by completing several assessments at the device. The assessments are identical between the moments. Hereby, ESM offers the opportunity to reduce the risk for recall bias and to capture symptom variability over time with taking into account contextual, social and psychological factors, which might have an impact on symptom reporting.
ESM has already been used in different patient populations with different disorders, such as; irritable bowel syndrome (IBS), depression, Parkinson's Disease and mental illness in a broad sense.
ESM has proven to be a viable and novel approach to assess symptoms, affective states and contextual factors at the level of the individual subject. It provides precise, prospective information that may contribute to clinical practice with several distinct advantages over traditionally used (retrospective) assessment of mental health related phenomena. OAB shows fluctuating symptom patterns in which urological complaints might be influenced by daily life factors as well as psychological and psychiatric comorbidities. To our knowledge, there are no previous studies on the use of ESM in a urological patient population. In order to study the performance of ESM in a population as such there is a need for developing a patient-reported outcome measure suitable for real-time symptom assessment of urological symptoms, using the ESM principle. Patient-reported outcome measures (PROMs) are assessment methods completed by patients, and are meant to capture one or several aspects of a disease course or health status. Focus group research in OAB patients was done for item selection and to evaluate the quality of the PROMs according to the ESM principle. The outcomes of the focus groups have been discussed in an expert meeting and a final questionnaire has been constructed, specifically for the ESM in the urological patient population. Now, this OAB-specific ESM tool should be tested to see if there is a difference between symptom scores on ESM and the currently used retrospective reports and SR-BDs. Furthermore content validity, reliability and the accuracy will be tested to validate the developed ePRO in OAB patients. Additionally, specific triggers for the onset of OAB complaints will be objectified, with use of the OAB specific ESM tool. It will be objectified if there is a direct link between OAB and psychiatric disorders as depression, anxiety and stress too.
Summarizing, electronic, repeated symptom assessments during daily activities should assure ecological validity and eliminate recall bias, lead to higher compliance rates, and capture symptom variability during the day. For these reasons it is expected that the Experience Sampling Method (ESM) may prove to be a more objective tool for evaluation and quantification of urgency and other urological complaints that will overcome the limitations of currently used retrospective symptom assessment methods in OAB.
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome
- Being tested
- Validation Experience Sampling Method 'Uromate'
- Keywords
- Experience Sampling Method, Ecological Momentary Assessment, Momentary Symptom Assessment, Patient Reported Outcome Measure
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| OAB patients | Not described Receives: Other: Validation Experience Sampling Method 'Uromate' | |
| Healthy volunteers | Not described Receives: Other: Validation Experience Sampling Method 'Uromate' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urgency (ESM score)
Urgency scores as measured by the Experience Sampling Method tool (i.e. momentary measurement)
Measured: 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)
Measured: 2 years
Secondary outcomes (7)
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)
Measured: 2 years
OABq symptom score
Urological symptoms in male and female participants: OABq
Measured: 2 years
ICIQ-FLUTS symptom score
Urological symptoms in female participants: ICIQ-FLUTS
Measured: 2 years
3IQ symptom score
Urological symptoms (incontinence) in male and female participants: 3IQ
Measured: 2 years
ICIQ-MLUTS symptom score
Urological symptoms in male participants: ICIQ-MLUTS
Measured: 2 years
IPSS symptom score
Urological symptoms in male participants: IPSS score
Measured: 2 years
IIEF-5 symptom score
Urological symptoms (erectile dysfunction) in male participants: IIEF-5
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start6 Aug 2018
- Primary completion5 Jan 2021 (estimated)
- Study completion5 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zuyderland Hospital, University Hospital, Antwerp
- Responsible party
- Sponsor
- Investigators
- Desiree Vrijens, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435991
- Sponsor's protocol ID
- NL63006.068.17
- Status last verified
- Feb 2020
- First submitted
- 8 Feb 2018
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mujagic Z, Leue C, Vork L, Lousberg R, Jonkers DM, Keszthelyi D, Hesselink MA, van Schagen TJ, van Os J, Masclee AA, Kruimel JW. The Experience Sampling Method--a new digital tool for momentary symptom assessment in IBS: an exploratory study. Neurogastroenterol Motil. 2015 Sep;27(9):1295-302. doi: 10.1111/nmo.12624. Epub 2015 Jun 22.
PubMed 26100684Simons CJ, Hartmann JA, Kramer I, Menne-Lothmann C, Hohn P, van Bemmel AL, Myin-Germeys I, Delespaul P, van Os J, Wichers M. Effects of momentary self-monitoring on empowerment in a randomized controlled trial in patients with depression. Eur Psychiatry. 2015 Nov;30(8):900-6. doi: 10.1016/j.eurpsy.2015.09.004. Epub 2015 Oct 6.
PubMed 26647864Verhagen SJ, Hasmi L, Drukker M, van Os J, Delespaul PA. Use of the experience sampling method in the context of clinical trials. Evid Based Ment Health. 2016 Aug;19(3):86-9. doi: 10.1136/ebmental-2016-102418.
PubMed 27443678van Os J, Verhagen S, Marsman A, Peeters F, Bak M, Marcelis M, Drukker M, Reininghaus U, Jacobs N, Lataster T, Simons C; ESM-MERGE Investigators PhD; Lousberg R, Guloksuz S, Leue C, Groot PC, Viechtbauer W, Delespaul P. The experience sampling method as an mHealth tool to support self-monitoring, self-insight, and personalized health care in clinical practice. Depress Anxiety. 2017 Jun;34(6):481-493. doi: 10.1002/da.22647. Epub 2017 May 23.
PubMed 28544391Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Coyne KS, Sexton CC, Vats V, Thompson C, Kopp ZS, Milsom I. National community prevalence of overactive bladder in the United States stratified by sex and age. Urology. 2011 May;77(5):1081-7. doi: 10.1016/j.urology.2010.08.039. Epub 2011 Jan 22.
PubMed 21256571Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
PubMed 11412210Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
PubMed 12811491Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
PubMed 17049716Coyne KS, Matza LS, Brewster-Jordan J. "We have to stop again?!": The impact of overactive bladder on family members. Neurourol Urodyn. 2009;28(8):969-75. doi: 10.1002/nau.20705.
PubMed 19301410Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13.
PubMed 21231991Hu TW, Wagner TH, Bentkover JD, LeBlanc K, Piancentini A, Stewart WF, Corey R, Zhou SZ, Hunt TL. Estimated economic costs of overactive bladder in the United States. Urology. 2003 Jun;61(6):1123-8. doi: 10.1016/s0090-4295(03)00009-8.
PubMed 12809878Sexton CC, Coyne KS, Vats V, Kopp ZS, Irwin DE, Wagner TH. Impact of overactive bladder on work productivity in the United States: results from EpiLUTS. Am J Manag Care. 2009 Mar;15(4 Suppl):S98-S107.
PubMed 19355804Foley AL, Loharuka S, Barrett JA, Mathews R, Williams K, McGrother CW, Roe BH. Association between the Geriatric Giants of urinary incontinence and falls in older people using data from the Leicestershire MRC Incontinence Study. Age Ageing. 2012 Jan;41(1):35-40. doi: 10.1093/ageing/afr125. Epub 2011 Sep 24.
PubMed 21948857Vrijens D, Drossaerts J, van Koeveringe G, Van Kerrebroeck P, van Os J, Leue C. Affective symptoms and the overactive bladder - a systematic review. J Psychosom Res. 2015 Feb;78(2):95-108. doi: 10.1016/j.jpsychores.2014.11.019. Epub 2014 Nov 27.
PubMed 25499886
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'The Experience Sampling Method (ESM): a Real-time Patient-Reported Outcome Measure for Symptom Assessment in Patients With Overactive Bladder Syndrome.'
- ClinicalTrials.gov ID
- NCT03435991
- Acronym / sponsor ID
- NL63006.068.17
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome
- Keywords
- Experience Sampling Method, Ecological Momentary Assessment, Momentary Symptom Assessment, Patient Reported Outcome Measure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Zuyderland Hospital, University Hospital, Antwerp
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 5 Jan 2021 (estimated)
- Study completion
- 5 Jan 2021 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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.
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).
Detailed description
The overactive bladder syndrome (OAB) is defined by the International Continence Society (ICS) as a symptom complex of urgency, usually with frequency and nocturia (awakening at night to void), with (OAB wet) or without (OAB dry) urinary urgency incontinence. Urgency is the complaint of a sudden compelling desire to pass urine, which is difficult to defer. OAB is clinically diagnosed using the ICS criteria of ≥8 micturitions and at least 1 urgency episode per 24 hours.
It is estimated that approximately 16-17% of the adult population of the Western world is affected by OAB. The incidence of OAB, both wet and dry increases by age, and because of the worldwide ageing of the population, the number of adults affected by urinary urgency incontinence (UUI) would increase. The health care costs of OAB are high, and work productivity can be significantly impacted as well. In addition, OAB can be associated with comorbidity and increased mortality. Furthermore, OAB with and without incontinence has been associated with significantly lower quality of life scores compared to matched controls without voiding complaints. It is of particular interest that OAB does not only affect the patients, but also has an impact on family members.
There is a strong association between OAB and psychiatric comorbidities such as depression, anxiety and stress. This association is most likely bidirectional.
The current methods of diagnosis rely on voiding diaries (the sensation-related bladder diary) and retrospective questionnaires.
Retrospective, self-reported outcomes have important limitations. Firstly, there is a high risk for recall bias, in which retrospective information consists of a reconstruction of a few specific moments rather than a reliable reflection of symptoms over a predefined period of time. Furthermore, it is well described that memory retrieval is influenced by the individual's environment and mental state at the time of recall, known as ecological bias. In conclusion, patient experiences about symptoms in the past can be significantly distorted when retrospectively reported. Furthermore, lack of patient compliance is an important disturbing factor in recalled assessments. Studies that employed paper diaries in a population of patients with chronic somatic pain to measure symptoms resulted in very low patient compliance: only 11% actual compliance, but up to 80% fake compliance was determined, the latter presumably resulting from filling in diaries after the proscribed time window.
The Experience Sampling Method (ESM), also referred to as Ecological Momentary Assessment (EMA), may overcome these limitations. ESM is an electronic questioning method characterized by random, repeated assessments in the subject's current state and environment, for several consecutive days. A digital device sends out an auditory beep at random moments during the day, to which subjects have to respond by completing several assessments at the device. The assessments are identical between the moments. Hereby, ESM offers the opportunity to reduce the risk for recall bias and to capture symptom variability over time with taking into account contextual, social and psychological factors, which might have an impact on symptom reporting.
ESM has already been used in different patient populations with different disorders, such as; irritable bowel syndrome (IBS), depression, Parkinson's Disease and mental illness in a broad sense.
ESM has proven to be a viable and novel approach to assess symptoms, affective states and contextual factors at the level of the individual subject. It provides precise, prospective information that may contribute to clinical practice with several distinct advantages over traditionally used (retrospective) assessment of mental health related phenomena. OAB shows fluctuating symptom patterns in which urological complaints might be influenced by daily life factors as well as psychological and psychiatric comorbidities. To our knowledge, there are no previous studies on the use of ESM in a urological patient population. In order to study the performance of ESM in a population as such there is a need for developing a patient-reported outcome measure suitable for real-time symptom assessment of urological symptoms, using the ESM principle. Patient-reported outcome measures (PROMs) are assessment methods completed by patients, and are meant to capture one or several aspects of a disease course or health status. Focus group research in OAB patients was done for item selection and to evaluate the quality of the PROMs according to the ESM principle. The outcomes of the focus groups have been discussed in an expert meeting and a final questionnaire has been constructed, specifically for the ESM in the urological patient population. Now, this OAB-specific ESM tool should be tested to see if there is a difference between symptom scores on ESM and the currently used retrospective reports and SR-BDs. Furthermore content validity, reliability and the accuracy will be tested to validate the developed ePRO in OAB patients. Additionally, specific triggers for the onset of OAB complaints will be objectified, with use of the OAB specific ESM tool. It will be objectified if there is a direct link between OAB and psychiatric disorders as depression, anxiety and stress too.
Summarizing, electronic, repeated symptom assessments during daily activities should assure ecological validity and eliminate recall bias, lead to higher compliance rates, and capture symptom variability during the day. For these reasons it is expected that the Experience Sampling Method (ESM) may prove to be a more objective tool for evaluation and quantification of urgency and other urological complaints that will overcome the limitations of currently used retrospective symptom assessment methods in OAB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAB patients | – | Other: Validation Experience Sampling Method 'Uromate' |
| Healthy volunteers | – | Other: Validation Experience Sampling Method 'Uromate' |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age between 18 and 70 years;
- Male and female
- Ability to understand and speak Dutch;
- Ability to understand how to utilize the ESM tool.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation Experience Sampling Method 'Uromate'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. | Other | Healthy volunteers, OAB patients |
Primary outcome
Urgency (ESM score)
Time frame: 2 years
Urgency scores as measured by the Experience Sampling Method tool (i.e. momentary measurement)
Urgency (SR-BD score)
Time frame: 2 years
Urgency scores as measured by the sensation-related bladder diary (i.e. retrospective measurement with a recall period of several minutes)
7 secondary outcomes
Symptom scores (other than urgency) as measured using the ESM tool
Time frame: 2 years
OABq symptom score
Time frame: 2 years
ICIQ-FLUTS symptom score
Time frame: 2 years
3IQ symptom score
Time frame: 2 years
ICIQ-MLUTS symptom score
Time frame: 2 years
IPSS symptom score
Time frame: 2 years
IIEF-5 symptom score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Background: PubMed 26100684Mujagic Z, Leue C, Vork L, Lousberg R, Jonkers DM, Keszthelyi D, Hesselink MA, van Schagen TJ, van Os J, Masclee AA, Kruimel JW. The Experience Sampling Method--a new digital tool for momentary symptom assessment in IBS: an exploratory study. Neurogastroenterol Motil. 2015 Sep;27(9):1295-302. doi: 10.1111/nmo.12624. Epub 2015 Jun 22.
- Background: PubMed 26647864Simons CJ, Hartmann JA, Kramer I, Menne-Lothmann C, Hohn P, van Bemmel AL, Myin-Germeys I, Delespaul P, van Os J, Wichers M. Effects of momentary self-monitoring on empowerment in a randomized controlled trial in patients with depression. Eur Psychiatry. 2015 Nov;30(8):900-6. doi: 10.1016/j.eurpsy.2015.09.004. Epub 2015 Oct 6.
- Background: PubMed 27443678Verhagen SJ, Hasmi L, Drukker M, van Os J, Delespaul PA. Use of the experience sampling method in the context of clinical trials. Evid Based Ment Health. 2016 Aug;19(3):86-9. doi: 10.1136/ebmental-2016-102418.
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- Individual participant dataSharing planned: Undecided
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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.
Desiree Vrijens, MD, PhD principal investigator
Maastricht University Medical Center
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 Overactive Bladder and Overactive Bladder Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Feb 2020. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Herrewegh, MD (+31(0)43 387 7259, alexandra.herrewegh@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urgency (ESM score) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435991, which also lists 29 linked publications.
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 21 Feb 2020.