Lower Urinary Tract SymptomsNCT03808038
Symptoms of Lower Urinary Tract Dysfunction Protocol 2/Recall Study
An observational study of Lower Urinary Tract Symptoms, run by Arbor Research Collaborative for Health at 6 sites in United States.
Trial summary
The purpose of this study is to advance the understanding of people who experience urinary and bladder problems. The investigators are interested in learning about people's experiences with urinary symptoms and how these symptoms will be managed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- None- Observational Study
- How many people
- 515 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 May 2017to 31 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria
Who may be able to join
- age 18 or older,
- willing and able to give informed consent,
- able to speak, read, and understand English,
- able to reliably complete self-reported questionnaires online at specified times (i.e., may exclude those who do not keep a regular schedule of sleeping during night hours), and
- experienced at least moderate severity and bother from at least 1 of the 7 targeted symptoms in the past 2 weeks and in the past 3 months
Who cannot join
- dementia or other cognitive impairment that would interfere with study participation,
- known pregnancy or delivery within past 6 months (women only)
- planned change in medications to treat LUTS in the middle of the study time frame,
- receiving active treatment for any malignancy (including maintenance medications),
- received surgery with general or spinal/epidural anesthesia in the past 3 months or planned surgery during the study time frame
- lower urinary tract instrumentation (e.g. self-catheterization or cystoscopy) in past 3 months or planned during the study time frame and
- prostate biopsy in the past 3 months or planned during the study time frame
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Northwestern University
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27715
University of Iowa
Iowa City, Iowa, 52242
University of Washington
Seattle, Washington, 98195
Washington University
St Louis, Missouri, 63110
About this study
Official title: Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study
The purpose of this study is to advance the understanding of people who experience urinary and bladder problems. The investigators are interested in learning about people's experiences with urinary symptoms and how these symptoms will be managed. The investigators want to understand the important differences among people and what factors affect urinary and bladder problems. After all of the information is collected, the investigators will have a better understanding of how to improve the care and treatment for people who have urinary and bladder problems.
Read the detailed description
This protocol is part of an overall effort to create a state-of-the-art resource for measuring patient-reported health for patients with lower urinary tract dysfunction (LUTD). The primary purpose of this resource, known as the LURN PRO Battery, is to comprehensively characterize the self-reported experiences of patients with LUTD for the purpose of enhancing efforts to characterize and explain important subtypes of patients with LUTD (phenotypes). Secondary purposes of the LURN PRO Battery, for which additional development work will be required, include developing better patient-reported endpoints for clinical trials, monitoring symptoms in the course of clinical care, and screening patients into important subgroups for purposes of tailored interventions.
Incorporating methods the investigators have used successfully in prior measure validation work, the investigators propose to conduct a diary study in which patients record their symptoms at various time points - at the end of each day, or across multiple days. The investigators also ask them to complete self-report measures with different recall periods (i.e., 3-day, 7-day, and 30-day recall), and will determine how well each of these correspond to daily experiences recorded in more frequent assessments (i.e., end-of-day and 3-day patient bladder diaries). These data will help LURN investigators to determine the most appropriate reporting period for specific symptoms. This study can also help to identify causes of differences that exist between shorter and longer recall periods.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- None- Observational Study
- Keywords
- Lower Urinary Tract Symptoms, Bladder Symptoms, Recall, Lower Urinary Tract Dysfunction
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None- Observational StudyOther
None- Observational Study
| Study group | Role | What they receive |
|---|---|---|
| No Diary Group | Group completed daily questionnaires for four weeks, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study Receives: Other: None- Observational Study | |
| Diary Start Group | Group completed bladder diaries in week 1, daily questionnaires in week 1, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study Receives: Other: None- Observational Study | |
| Daily Start Group | Group completed daily questionnaires in week 1, bladder diaries in week 2, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study Receives: Other: None- Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine ideal recall period for LUTS symptoms
The investigators will administer and analyze the correspondence between patient's average daily recall of their LUTS utilizing seven, daily questionnaires, their weekly recall of self-reported LUTS using a 7-day recall questionnaire, as well as a questionnaire assessing their monthly LUTS recall in order to determine the best recall period to utilize when administering LUTS questionnaires in clinical settings.
Measured: Through study completion - 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start26 May 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Cross-sectional
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Research Collaborative for Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Northwestern University, Duke University, University of Iowa, University of Washington, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Kevin P. Weinfurt, PhD, Study chair, Duke UniversityClaire C. Yang, MD, Study chair, University of WashingtonRobert M. Merion, MD, FACS, Principal investigator, Arbor Research Collaborative for Health - DCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808038
- Sponsor's protocol ID
- LURN Recall Study
- Other IDs
- U01DK097780, U01DK097772, U01DK097779, U01DK099932, U01DK100011, U01DK100017, U01DK097776, U01DK099879
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Protocol 2/Recall Study
- ClinicalTrials.gov ID
- NCT03808038
- Acronym / sponsor ID
- LURN Recall Study
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Bladder Symptoms, Recall, Lower Urinary Tract Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Arbor Research Collaborative for HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Northwestern University, Duke University, University of Iowa, University of Washington, Washington University School of Medicine
- Study start
- 26 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 17 Jan 2019 (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.
The purpose of this study is to advance the understanding of people who experience urinary and bladder problems. The investigators are interested in learning about people's experiences with urinary symptoms and how these symptoms will be managed. The investigators want to understand the important differences among people and what factors affect urinary and bladder problems. After all of the information is collected, the investigators will have a better understanding of how to improve the care and treatment for people who have urinary and bladder problems.
Detailed description
This protocol is part of an overall effort to create a state-of-the-art resource for measuring patient-reported health for patients with lower urinary tract dysfunction (LUTD). The primary purpose of this resource, known as the LURN PRO Battery, is to comprehensively characterize the self-reported experiences of patients with LUTD for the purpose of enhancing efforts to characterize and explain important subtypes of patients with LUTD (phenotypes). Secondary purposes of the LURN PRO Battery, for which additional development work will be required, include developing better patient-reported endpoints for clinical trials, monitoring symptoms in the course of clinical care, and screening patients into important subgroups for purposes of tailored interventions.
Incorporating methods the investigators have used successfully in prior measure validation work, the investigators propose to conduct a diary study in which patients record their symptoms at various time points - at the end of each day, or across multiple days. The investigators also ask them to complete self-report measures with different recall periods (i.e., 3-day, 7-day, and 30-day recall), and will determine how well each of these correspond to daily experiences recorded in more frequent assessments (i.e., end-of-day and 3-day patient bladder diaries). These data will help LURN investigators to determine the most appropriate reporting period for specific symptoms. This study can also help to identify causes of differences that exist between shorter and longer recall periods.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Diary Group | – | Other: None- Observational StudyGroup completed daily questionnaires for four weeks, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study |
| Diary Start Group | – | Other: None- Observational StudyGroup completed bladder diaries in week 1, daily questionnaires in week 1, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study |
| Daily Start Group | – | Other: None- Observational StudyGroup completed daily questionnaires in week 1, bladder diaries in week 2, a weekly questionnaire at the end of each week, and a monthly questionnaire at the end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- age 18 or older,
- willing and able to give informed consent,
- able to speak, read, and understand English,
- able to reliably complete self-reported questionnaires online at specified times (i.e., may exclude those who do not keep a regular schedule of sleeping during night hours), and
- experienced at least moderate severity and bother from at least 1 of the 7 targeted symptoms in the past 2 weeks and in the past 3 months
Key exclusion criteria (7 listed)
- dementia or other cognitive impairment that would interfere with study participation,
- known pregnancy or delivery within past 6 months (women only)
- planned change in medications to treat LUTS in the middle of the study time frame,
- receiving active treatment for any malignancy (including maintenance medications),
- received surgery with general or spinal/epidural anesthesia in the past 3 months or planned surgery during the study time frame
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 |
|---|---|---|
| None- Observational StudyNone- Observational Study | Other | Daily Start Group, Diary Start Group, No Diary Group |
Primary outcome
Determine ideal recall period for LUTS symptoms
Time frame: Through study completion - 30 days
The investigators will administer and analyze the correspondence between patient's average daily recall of their LUTS utilizing seven, daily questionnaires, their weekly recall of self-reported LUTS using a 7-day recall questionnaire, as well as a questionnaire assessing their monthly LUTS recall in order to determine the best recall period to utilize when administering LUTS questionnaires in clinical settings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Individual participant dataSharing planned: No. We do not plan to make IPD available.
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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.
Kevin P. Weinfurt, PhD study chair
Duke University
Claire C. Yang, MD study chair
University of Washington
Robert M. Merion, MD, FACS principal investigator
Arbor Research Collaborative for Health - DCC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by Arbor Research Collaborative for Health at 6 sites in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine ideal recall period for LUTS symptoms (time frame: Through study completion - 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.