Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
132 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-08-06
Study Completion Date
2021-01-05
Brief Summary
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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).
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).
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Detailed Description
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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.
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
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Overactive Bladder
Overactive Bladder Syndrome
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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OAB patients
Validation Experience Sampling Method 'Uromate'
Intervention Type
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
Validation Experience Sampling Method 'Uromate'
Intervention Type
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.
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 70 years;
* Male and female
* Ability to understand and speak Dutch;
* Ability to understand how to utilize the ESM tool.
* Male and female
* Ability to understand and speak Dutch;
* Ability to understand how to utilize the ESM tool.
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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Zuyderland Hospital
UNKNOWN
Sponsor Role
collaborator
University Hospital, Antwerp
OTHER
Sponsor Role
collaborator
Maastricht University Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Desiree Vrijens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Maastricht Univeristy Medical Center+
Maastricht, , Netherlands
Site Status
RECRUITING
Countries
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Netherlands
Central Contacts
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Facility Contacts
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References
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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.
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Simons 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.
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BACKGROUND
Verhagen 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.
Reference Type
BACKGROUND
van 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.
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BACKGROUND
Abrams 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.
Reference Type
BACKGROUND
Coyne 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.
Reference Type
BACKGROUND
Milsom 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.
Reference Type
BACKGROUND
Stewart 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.
Reference Type
BACKGROUND
Irwin 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.
Reference Type
BACKGROUND
Coyne 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.
Reference Type
BACKGROUND
Irwin 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.
Reference Type
BACKGROUND
Hu 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.
Reference Type
BACKGROUND
Sexton 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.
Reference Type
BACKGROUND
Foley 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.
Reference Type
BACKGROUND
Vrijens 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.
Reference Type
BACKGROUND
Melville JL, Delaney K, Newton K, Katon W. Incontinence severity and major depression in incontinent women. Obstet Gynecol. 2005 Sep;106(3):585-92. doi: 10.1097/01.AOG.0000173985.39533.37.
Reference Type
BACKGROUND
Litman HJ, Steers WD, Wei JT, Kupelian V, Link CL, McKinlay JB; Boston Area Community Health Survey Investigators. Relationship of lifestyle and clinical factors to lower urinary tract symptoms: results from Boston Area Community Health survey. Urology. 2007 Nov;70(5):916-21. doi: 10.1016/j.urology.2007.06.1117. Epub 2007 Oct 24.
Reference Type
BACKGROUND
Choi EP, Lam CL, Chin WY. Mental Health Mediating the Relationship Between Symptom Severity and Health-Related Quality of Life in Patients with Lower Urinary Tract Symptoms. Low Urin Tract Symptoms. 2016 Sep;8(3):141-9. doi: 10.1111/luts.12086. Epub 2015 Feb 12.
Reference Type
BACKGROUND
Martin S, Vincent A, Taylor AW, Atlantis E, Jenkins A, Januszewski A, O'Loughlin P, Wittert G. Lower Urinary Tract Symptoms, Depression, Anxiety and Systemic Inflammatory Factors in Men: A Population-Based Cohort Study. PLoS One. 2015 Oct 7;10(10):e0137903. doi: 10.1371/journal.pone.0137903. eCollection 2015.
Reference Type
BACKGROUND
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
Reference Type
BACKGROUND
Myin-Germeys I, Oorschot M, Collip D, Lataster J, Delespaul P, van Os J. Experience sampling research in psychopathology: opening the black box of daily life. Psychol Med. 2009 Sep;39(9):1533-47. doi: 10.1017/S0033291708004947. Epub 2009 Feb 12.
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BACKGROUND
Houtveen JH, Oei NY. Recall bias in reporting medically unexplained symptoms comes from semantic memory. J Psychosom Res. 2007 Mar;62(3):277-82. doi: 10.1016/j.jpsychores.2006.11.006.
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BACKGROUND
Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient compliance with paper and electronic diaries. Control Clin Trials. 2003 Apr;24(2):182-99. doi: 10.1016/s0197-2456(02)00320-3.
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Moskowitz DS, Young SN. Ecological momentary assessment: what it is and why it is a method of the future in clinical psychopharmacology. J Psychiatry Neurosci. 2006 Jan;31(1):13-20.
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BACKGROUND
Hartmann JA, Wichers M, Menne-Lothmann C, Kramer I, Viechtbauer W, Peeters F, Schruers KR, van Bemmel AL, Myin-Germeys I, Delespaul P, van Os J, Simons CJ. Experience sampling-based personalized feedback and positive affect: a randomized controlled trial in depressed patients. PLoS One. 2015 Jun 2;10(6):e0128095. doi: 10.1371/journal.pone.0128095. eCollection 2015.
Reference Type
BACKGROUND
Wichers M, Simons CJ, Kramer IM, Hartmann JA, Lothmann C, Myin-Germeys I, van Bemmel AL, Peeters F, Delespaul P, van Os J. Momentary assessment technology as a tool to help patients with depression help themselves. Acta Psychiatr Scand. 2011 Oct;124(4):262-72. doi: 10.1111/j.1600-0447.2011.01749.x. Epub 2011 Aug 13.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Palmier-Claus JE, Myin-Germeys I, Barkus E, Bentley L, Udachina A, Delespaul PA, Lewis SW, Dunn G. Experience sampling research in individuals with mental illness: reflections and guidance. Acta Psychiatr Scand. 2011 Jan;123(1):12-20. doi: 10.1111/j.1600-0447.2010.01596.x. Epub 2010 Aug 16.
Reference Type
BACKGROUND
Alrubaiy L, Hutchings HA, Williams JG. Assessing patient reported outcome measures: A practical guide for gastroenterologists. United European Gastroenterol J. 2014 Dec;2(6):463-70. doi: 10.1177/2050640614558345.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NL63006.068.17
Identifier Type: -
Identifier Source: org_study_id
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UNKNOWN
PHASE4
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
NCT03583372
COMPLETED
PHASE3
Treatment of the Overactive Bladder Syndrome: A Delphi Study
NCT04300400
COMPLETED
A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
NCT02386072
COMPLETED
Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women
NCT00143481
COMPLETED
PHASE4