Lower Urinary Tract SymptomsNCT02485808
Symptoms of Lower Urinary Tract Dysfunction Phenotyping 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 our understanding of people who experience urinary and bladder problems. We 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 olderHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- None-observational, Magnetic Resonance Imaging (MRI) and Multimodal Automated Sensory Testing System
- Type of treatment
- Surgery or procedure
- How many people
- 1,879 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2015to 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: New patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria (below).
Who may be able to join
- Men and women presenting for new patient visits for evaluation or treatment of LUTS to one of the LURN physicians.
- Age ≥ 18 years.
- The presence of any of the symptoms reported in Table 1, based on responses to the LUTS Tool with a one month recall period.
- The ability to give informed consent and complete self-reported questionnaires electronically.
- Table 1: LUTS Appropriate for Study Inclusion
- Daytime frequency
Show all 21Show fewer
- Nocturia
- Urgency
- Incontinence/leakage (various types)
- Poor or absent sensation of bladder filling
- Slow/weak stream
- Splitting or spraying
- Intermittent stream/Double voiding
- Hesitancy
- Straining
- Dribbling at the end of flow
- Paruesis (shy bladder syndrome)
- Poor or absent sensation of urethra during void
- Feeling of incomplete emptying
- Post-micturition dribble (delayed)
- Abnormal bladder or urethral sensations
Who cannot join
- Gross hematuria.
- Significant neurologic disease or injury, including but not limited to: cerebral vascular accident with residual defect, Alzheimer's dementia, Parkinson's disease, traumatic brain injury, spinal cord injury, complicated spinal surgery, multiple sclerosis.
- Primary complaint is pelvic pain.
- Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia.
- Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
- Current sexually transmitted infection. (deferral; subject can enroll after negative culture)
Show all 20Show fewer
- Ongoing symptomatic urethral stricture.
- History of lower urinary tract or pelvic malignancy.
- Current chemotherapy or other cancer therapy.
- Pelvic device or implant complication (e.g., sling or mesh complications).
- Current functioning neurostimulator.
- Botox injection to the bladder or pelvic structures within the preceding 12 months.
- In men, prostate biopsy in the previous 3 months.
- In women, pregnancy.
- History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.
- Augmentation cystoplasty or cystectomy.
- Presence of urinary tract fistula.
- Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.).
- Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease).
- Difficulty reading or communicating in English.
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) Phenotyping Study Protocol
The purpose of this study is to advance our understanding of people who experience urinary and bladder problems. We are interested in learning about people's experiences with urinary symptoms and how these symptoms will be managed. We want to understand the important differences among people and what factors affect urinary and bladder problems. After all of the information is collected, we 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
The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to advance our understanding of lower urinary tract dysfunction (LUTD) in women and men. LUTD is a term intended to be comprehensive and to challenge current paradigms about how symptomatic pelvic disorders are defined as 'diseases.' Lower urinary tract symptoms (LUTS) are likely caused and exacerbated by a variety of factors and thus do not represent the manifestation of a single disease. Clinical management of LUTD, including treatment outcomes, remains suboptimal since the biological and psychosocial factors that initiate, exacerbate, and modify this group of symptoms remain largely unknown. As an initial effort to better characterize the biological and psychosocial factors that initiate, exacerbate, and modify LUTS, the LURN investigators will establish a prospective Observational Cohort Study of men and women with LUTS presenting for the first time to LURN physicians.
Information to be obtained from study participants initially (at time of enrollment) includes a standardized clinical examination, medical history, select testing of the lower urinary tract, and participants' self-report of LUTS, pelvic floor symptoms including sexual function and bowel symptoms, depression, anxiety, sleep patterns, stress, metabolic risk factors, and health-related quality of life. We will also collect serum, urine, saliva, and perineal swabs from men and vaginal swabs from women for storage at the NIDDK Sample Repository for future study by the LURN investigators and the broader research community. This information will be used to construct subgroups of patients who have similar symptoms, clinical presentations, comorbidities, pelvic floor dysfunctions, and psychological profiles. These patient characteristics and behaviors likely affect the evaluation, diagnosis, and/or treatment of LUTS. Additional information will be collected 3 months and 12 months after enrollment or 3 and 12 months after surgery for patients receiving surgical treatment, and will include an interval clinical history, participants' self-report of LUTS, pelvic floor symptoms including sexual function and bowel symptoms, depression, anxiety, and health-related quality of life. We will also collect biological samples at 3 and 12 months after enrollment.
The LURN Neuroimaging and Sensory Testing component of the study will investigate abnormal sensation of the lower urinary tract at the level of the organism. Subjects and controls will have a one-time visit soon after their baseline visit, where they will undergo an fMRI scan of their brain and multimodal quantitative sensory testing assessing perceptual responses to physical stimuli (pain and sound).
The information to be collected from the prospective Observational Cohort Study will be limited and not sufficient to fully understand the pathophysiology and biology of LUTS. Therefore, the Observational Cohort Study will serve as the basis for further LURN studies. The long-term goal of the LURN is to better characterize patients with LUTD in order to advance future research on the pathophysiology of these
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- None-observational, Magnetic Resonance Imaging (MRI), Multimodal Automated Sensory Testing System, Auditory Sensitivity Test
- Keywords
- Lower Urinary Tract Symptoms, Bladder Symptoms, Overactive Bladder, Urinary Urgency, Lower Urinary Tract Dysfunction
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-observationalOther
For surgical patients, follow-up assessments will occur 3 and 12 months after the surgery. For medical patients, follow-up assessments will occur 3 and 12 months after the baseline assessment.
Magnetic Resonance Imaging (MRI)Procedure or surgery
Also called MRI
One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
Multimodal Automated Sensory Testing SystemOther
Also called Pain Sensitivity
Pressure pain thresholds will be assess using computer-controlled pressures delivered by a device called the Multimodal Automated Sensory Testing System (MAST) device on to the subjects thumbnail bed.
Auditory Sensitivity TestOther
Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Men and women presenting for clinical care for whom surgical treatment of their lower urinary symptoms is planned.
There will be no interventions, as this is an observational cohort. Receives: Other: None-observational | |
| Medical | Men and women presenting for clinical care for whom medical treatment of their lower urinary symptoms is planned.
There will be no interventions, as this is an observational cohort. Receives: Other: None-observational | |
| Controls | Men and women who are not experiencing lower urinary tract symptoms.
This group will undergo MRI, pain and auditory sensitivity testing. Receives: Procedure: Magnetic Resonance Imaging (MRI); Other: Multimodal Automated Sensory Testing System; Other: Auditory Sensitivity Test | |
| Neuroimaging & Sensory Testing | Subjects from the Medical and Surgical Cohorts who agree to additional testing in the form of neuroimaging (via fMRI) and multimodal sensory testing.
This group will undergo MRI, pain and auditory sensitivity testing. Receives: Procedure: Magnetic Resonance Imaging (MRI); Other: Multimodal Automated Sensory Testing System; Other: Auditory Sensitivity Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically relevant subgroups of patients with lower urinary tract symptoms
Identification of patient clusters based on their symptoms, clinical assessments, and/or other characteristics.
Measured: Baseline
Secondary outcomes (1)
Change in lower urinary tract symptoms
Measured: baseline, 3 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 1,879 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 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
- NCT02485808
- Sponsor's protocol ID
- LURN Phenotyping Study V8.0
- Other IDs
- U01DK100017, U01DK100011, U01DK099932, U01DK099879, U01DK097780, U01DK097779, U01DK097776, U01DK097772
- Status last verified
- Jan 2019
- First submitted
- 26 Jun 2015
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: We do not plan to make IPD available.
Publications
Coyne KS, Matza LS, Kopp ZS, Thompson C, Henry D, Irwin DE, Artibani W, Herschorn S, Milsom I. Examining lower urinary tract symptom constellations using cluster analysis. BJU Int. 2008 May;101(10):1267-73. doi: 10.1111/j.1464-410X.2008.07598.x. Epub 2008 Mar 11.
PubMed 18336611Coyne KS, Barsdorf AI, Thompson C, Ireland A, Milsom I, Chapple C, Kopp ZS, Bavendam T. Moving towards a comprehensive assessment of lower urinary tract symptoms (LUTS). Neurourol Urodyn. 2012 Apr;31(4):448-54. doi: 10.1002/nau.21202. Epub 2012 Mar 6.
PubMed 22396308Bower WF, Yip SK, Yeung CK. Dysfunctional elimination symptoms in childhood and adulthood. J Urol. 2005 Oct;174(4 Pt 2):1623-7; discussion 1627-8. doi: 10.1097/01.ju.0000176599.91836.12.
PubMed 16148668Bardwick GE, Fossa AJ, An H, Thomas J, Bieber B, Flynn KE, Ippolito GM, Marquez M, Taddeo M, Griffith JW; LURN Study Group. Lived Experiences of Emotional Distress Among Patients With Lower Urinary Tract Symptoms: A Mixed-Methods Study. Neurourol Urodyn. 2026 Oct 5. doi: 10.1002/nau.70448. Online ahead of print.
PubMed 42831270Lai HH; LURN Study Group. The LURN Study-What Have We "LURN"ed So Far? Neurourol Urodyn. 2026 Apr;45(4):654-661. doi: 10.1002/nau.70224.
PubMed 41944009Helmuth ME, Smith AR, Glaser AP, Yang CC, Cameron AP, Henry Lai H, Griffith JW, Eric Jelovsek J, Quentin Clemens J, Helfand BT, Merion RM, Andreev VP; and the LURN Study Group. Phenotyping Men With Lower Urinary Tract Symptoms: Results From the Symptoms of Lower Urinary Tract Dysfunction Research Network. Neurourol Urodyn. 2025 Jan;44(1):178-193. doi: 10.1002/nau.25596. Epub 2024 Oct 7.
PubMed 39370868Lai HH, Rutlin J, Smith AR, Helmuth ME, Hokanson JA, Yang CC, Clemens JQ, Magnotta VA, Bretschneider CE, Kenton K, DeLancey JOL, John K, Kirkali Z, Shimony JS. Structural Changes in Brain White Matter Tracts Associated With Overactive Bladder Revealed by Diffusion Tensor Magnetic Resonance Imaging: Findings From a Symptoms of Lower Urinary Tract Dysfunction Research Network Cross-Sectional Case-Control Study. J Urol. 2024 Aug;212(2):351-361. doi: 10.1097/JU.0000000000004022. Epub 2024 May 8.
PubMed 38717915Mawla I, Schrepf A, Kutch JJ, Helmuth ME, Smith AR, Ichesco E, Yang CC, Andreev VP, Kreder KJ, Bradley CS, Magnotta VA, Kirkali Z, Harris RE, Lai HH, Harte SE. Naturalistic Bladder Filling Reveals Subtypes in Overactive Bladder Syndrome That Differentially Engages Urinary Urgency-Related Brain Circuits: Results From the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). J Urol. 2024 Jan;211(1):111-123. doi: 10.1097/JU.0000000000003699. Epub 2023 Oct 5.
PubMed 37796776Harte SE, Wiseman J, Wang Y, Smith AR, Yang CC, Helmuth M, Kreder K, Kruger GH, Gillespie BW, Amundsen C, Kirkali Z, Lai HH; LURN Study Group. Experimental Pain and Auditory Sensitivity in Overactive Bladder Syndrome: A Symptoms of the Lower Urinary Tract Dysfunction Research Network (LURN) Study. J Urol. 2022 Jan;207(1):161-171. doi: 10.1097/JU.0000000000002147. Epub 2022 Aug 25.
PubMed 34428922Helmuth ME, Smith AR, Andreev VP, Liu G; LURN Study Group; Lai HH, Cameron AP, Siddiqui NY. Use of Euclidean length to measure urinary incontinence severity based on the lower urinary tract symptoms tool. Am J Obstet Gynecol. 2018 Mar;218(3):357-359. doi: 10.1016/j.ajog.2017.12.219. Epub 2017 Dec 26. No abstract available.
PubMed 29288065
Study at a glance
From the registry record, last updated by the sponsor on 15 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) Phenotyping Study Protocol
- ClinicalTrials.gov ID
- NCT02485808
- Acronym / sponsor ID
- LURN Phenotyping Study V8.0
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Bladder Symptoms, Overactive Bladder, Urinary Urgency, Lower Urinary Tract Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,879 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
- Apr 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 30 Jun 2015 (estimated)
- 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 our understanding of people who experience urinary and bladder problems. We are interested in learning about people's experiences with urinary symptoms and how these symptoms will be managed. We want to understand the important differences among people and what factors affect urinary and bladder problems. After all of the information is collected, we will have a better understanding of how to improve the care and treatment for people who have urinary and bladder problems.
Detailed description
The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to advance our understanding of lower urinary tract dysfunction (LUTD) in women and men. LUTD is a term intended to be comprehensive and to challenge current paradigms about how symptomatic pelvic disorders are defined as 'diseases.' Lower urinary tract symptoms (LUTS) are likely caused and exacerbated by a variety of factors and thus do not represent the manifestation of a single disease. Clinical management of LUTD, including treatment outcomes, remains suboptimal since the biological and psychosocial factors that initiate, exacerbate, and modify this group of symptoms remain largely unknown. As an initial effort to better characterize the biological and psychosocial factors that initiate, exacerbate, and modify LUTS, the LURN investigators will establish a prospective Observational Cohort Study of men and women with LUTS presenting for the first time to LURN physicians.
Information to be obtained from study participants initially (at time of enrollment) includes a standardized clinical examination, medical history, select testing of the lower urinary tract, and participants' self-report of LUTS, pelvic floor symptoms including sexual function and bowel symptoms, depression, anxiety, sleep patterns, stress, metabolic risk factors, and health-related quality of life. We will also collect serum, urine, saliva, and perineal swabs from men and vaginal swabs from women for storage at the NIDDK Sample Repository for future study by the LURN investigators and the broader research community. This information will be used to construct subgroups of patients who have similar symptoms, clinical presentations, comorbidities, pelvic floor dysfunctions, and psychological profiles. These patient characteristics and behaviors likely affect the evaluation, diagnosis, and/or treatment of LUTS. Additional information will be collected 3 months and 12 months after enrollment or 3 and 12 months after surgery for patients receiving surgical treatment, and will include an interval clinical history, participants' self-report of LUTS, pelvic floor symptoms including sexual function and bowel symptoms, depression, anxiety, and health-related quality of life. We will also collect biological samples at 3 and 12 months after enrollment.
The LURN Neuroimaging and Sensory Testing component of the study will investigate abnormal sensation of the lower urinary tract at the level of the organism. Subjects and controls will have a one-time visit soon after their baseline visit, where they will undergo an fMRI scan of their brain and multimodal quantitative sensory testing assessing perceptual responses to physical stimuli (pain and sound).
The information to be collected from the prospective Observational Cohort Study will be limited and not sufficient to fully understand the pathophysiology and biology of LUTS. Therefore, the Observational Cohort Study will serve as the basis for further LURN studies. The long-term goal of the LURN is to better characterize patients with LUTD in order to advance future research on the pathophysiology of these
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | Other: None-observationalMen and women presenting for clinical care for whom surgical treatment of their lower urinary symptoms is planned. There will be no interventions, as this is an observational cohort. |
| Medical | – | Other: None-observationalMen and women presenting for clinical care for whom medical treatment of their lower urinary symptoms is planned. There will be no interventions, as this is an observational cohort. |
| Controls | – | Procedure: Magnetic Resonance Imaging (MRI), Other: Multimodal Automated Sensory Testing System, Other: Auditory Sensitivity TestMen and women who are not experiencing lower urinary tract symptoms. This group will undergo MRI, pain and auditory sensitivity testing. |
| Neuroimaging & Sensory Testing | – | Procedure: Magnetic Resonance Imaging (MRI), Other: Multimodal Automated Sensory Testing System, Other: Auditory Sensitivity TestSubjects from the Medical and Surgical Cohorts who agree to additional testing in the form of neuroimaging (via fMRI) and multimodal sensory testing. This group will undergo MRI, pain and auditory sensitivity testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria (below).
Key inclusion criteria (21 listed)
- Men and women presenting for new patient visits for evaluation or treatment of LUTS to one of the LURN physicians.
- Age ≥ 18 years.
- The presence of any of the symptoms reported in Table 1, based on responses to the LUTS Tool with a one month recall period.
- The ability to give informed consent and complete self-reported questionnaires electronically.
- Table 1: LUTS Appropriate for Study Inclusion
Key exclusion criteria (20 listed)
- Gross hematuria.
- Significant neurologic disease or injury, including but not limited to: cerebral vascular accident with residual defect, Alzheimer's dementia, Parkinson's disease, traumatic brain injury, spinal cord injury, complicated spinal surgery, multiple sclerosis.
- Primary complaint is pelvic pain.
- Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia.
- Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
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-observationalFor surgical patients, follow-up assessments will occur 3 and 12 months after the surgery. For medical patients, follow-up assessments will occur 3 and 12 months after the baseline assessment. | Other | Medical, Surgical |
| Magnetic Resonance Imaging (MRI)Also: MRIOne time MRI scanning session examining brain structure and function in a resting state and after water consumption. | Procedure or surgery | Controls, Neuroimaging & Sensory Testing |
| Multimodal Automated Sensory Testing SystemAlso: Pain SensitivityPressure pain thresholds will be assess using computer-controlled pressures delivered by a device called the Multimodal Automated Sensory Testing System (MAST) device on to the subjects thumbnail bed. | Other | Controls, Neuroimaging & Sensory Testing |
| Auditory Sensitivity TestSubjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device. | Other | Controls, Neuroimaging & Sensory Testing |
Primary outcome
Clinically relevant subgroups of patients with lower urinary tract symptoms
Time frame: Baseline
Identification of patient clusters based on their symptoms, clinical assessments, and/or other characteristics.
1 secondary outcome
Change in lower urinary tract symptoms
Time frame: baseline, 3 months, and 12 months
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 15 Jan 2019.
- Background: PubMed 18336611Coyne KS, Matza LS, Kopp ZS, Thompson C, Henry D, Irwin DE, Artibani W, Herschorn S, Milsom I. Examining lower urinary tract symptom constellations using cluster analysis. BJU Int. 2008 May;101(10):1267-73. doi: 10.1111/j.1464-410X.2008.07598.x. Epub 2008 Mar 11.
- Background: PubMed 22396308Coyne KS, Barsdorf AI, Thompson C, Ireland A, Milsom I, Chapple C, Kopp ZS, Bavendam T. Moving towards a comprehensive assessment of lower urinary tract symptoms (LUTS). Neurourol Urodyn. 2012 Apr;31(4):448-54. doi: 10.1002/nau.21202. Epub 2012 Mar 6.
- Background: PubMed 16148668Bower WF, Yip SK, Yeung CK. Dysfunctional elimination symptoms in childhood and adulthood. J Urol. 2005 Oct;174(4 Pt 2):1623-7; discussion 1627-8. doi: 10.1097/01.ju.0000176599.91836.12.
- Derived from this study: PubMed 42831270Bardwick GE, Fossa AJ, An H, Thomas J, Bieber B, Flynn KE, Ippolito GM, Marquez M, Taddeo M, Griffith JW; LURN Study Group. Lived Experiences of Emotional Distress Among Patients With Lower Urinary Tract Symptoms: A Mixed-Methods Study. Neurourol Urodyn. 2026 Oct 5. doi: 10.1002/nau.70448. Online ahead of print.
- Derived from this study: PubMed 41944009Lai HH; LURN Study Group. The LURN Study-What Have We "LURN"ed So Far? Neurourol Urodyn. 2026 Apr;45(4):654-661. doi: 10.1002/nau.70224.
- Derived from this study: PubMed 39370868Helmuth ME, Smith AR, Glaser AP, Yang CC, Cameron AP, Henry Lai H, Griffith JW, Eric Jelovsek J, Quentin Clemens J, Helfand BT, Merion RM, Andreev VP; and the LURN Study Group. Phenotyping Men With Lower Urinary Tract Symptoms: Results From the Symptoms of Lower Urinary Tract Dysfunction Research Network. Neurourol Urodyn. 2025 Jan;44(1):178-193. doi: 10.1002/nau.25596. Epub 2024 Oct 7.
- Derived from this study: PubMed 38717915Lai HH, Rutlin J, Smith AR, Helmuth ME, Hokanson JA, Yang CC, Clemens JQ, Magnotta VA, Bretschneider CE, Kenton K, DeLancey JOL, John K, Kirkali Z, Shimony JS. Structural Changes in Brain White Matter Tracts Associated With Overactive Bladder Revealed by Diffusion Tensor Magnetic Resonance Imaging: Findings From a Symptoms of Lower Urinary Tract Dysfunction Research Network Cross-Sectional Case-Control Study. J Urol. 2024 Aug;212(2):351-361. doi: 10.1097/JU.0000000000004022. Epub 2024 May 8.
- Derived from this study: PubMed 37796776Mawla I, Schrepf A, Kutch JJ, Helmuth ME, Smith AR, Ichesco E, Yang CC, Andreev VP, Kreder KJ, Bradley CS, Magnotta VA, Kirkali Z, Harris RE, Lai HH, Harte SE. Naturalistic Bladder Filling Reveals Subtypes in Overactive Bladder Syndrome That Differentially Engages Urinary Urgency-Related Brain Circuits: Results From the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). J Urol. 2024 Jan;211(1):111-123. doi: 10.1097/JU.0000000000003699. Epub 2023 Oct 5.
- Derived from this study: PubMed 34428922Harte SE, Wiseman J, Wang Y, Smith AR, Yang CC, Helmuth M, Kreder K, Kruger GH, Gillespie BW, Amundsen C, Kirkali Z, Lai HH; LURN Study Group. Experimental Pain and Auditory Sensitivity in Overactive Bladder Syndrome: A Symptoms of the Lower Urinary Tract Dysfunction Research Network (LURN) Study. J Urol. 2022 Jan;207(1):161-171. doi: 10.1097/JU.0000000000002147. Epub 2022 Aug 25.
- Derived from this study: PubMed 29288065Helmuth ME, Smith AR, Andreev VP, Liu G; LURN Study Group; Lai HH, Cameron AP, Siddiqui NY. Use of Euclidean length to measure urinary incontinence severity based on the lower urinary tract symptoms tool. Am J Obstet Gynecol. 2018 Mar;218(3):357-359. doi: 10.1016/j.ajog.2017.12.219. Epub 2017 Dec 26. No abstract available.
- Study websiteLink provided by the sponsor.
- 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 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 21 inclusion and 20 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 15 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?
Clinically relevant subgroups of patients with lower urinary tract symptoms (time frame: Baseline). 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 NCT02485808, which also lists 10 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 15 Jan 2019.