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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK100017 | U.S. NIH Grant/Contract | View source | |
| U01DK100011 | U.S. NIH Grant/Contract | View source | |
| U01DK099932 | U.S. NIH Grant/Contract | View source | |
| U01DK099879 | U.S. NIH Grant/Contract | View source | |
| U01DK097780 | U.S. NIH Grant/Contract | View source | |
| U01DK097779 | U.S. NIH Grant/Contract | View source | |
| U01DK097776 | U.S. NIH Grant/Contract | View source | |
| U01DK097772 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Michigan | OTHER |
| Northwestern University | OTHER |
| Duke University |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| Controls | Men and women who are not experiencing lower urinary tract symptoms. This group will undergo MRI, pain and auditory sensitivity testing. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None-observational | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically relevant subgroups of patients with lower urinary tract symptoms | Identification of patient clusters based on their symptoms, clinical assessments, and/or other characteristics. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lower urinary tract symptoms | baseline, 3 months, and 12 months |
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Inclusion Criteria:
Table 1: LUTS Appropriate for Study Inclusion
Exclusion Criteria:
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New patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria (below).
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| Name | Affiliation | Role |
|---|---|---|
| Kevin P Weinfurt, PhD | Duke University | Study Chair |
| Claire Yang, MD | University of Washington | Study Chair |
| Robert M Merion, MD, FACS | Arbor Research Collaborative for Health - DCC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Iowa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18336611 | Background | 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. | |
| 22396308 | Background | Coyne 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. |
| Label | URL |
|---|---|
| Study website | View source |
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We do not plan to make IPD available.
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| OTHER |
| University of Iowa | OTHER |
| University of Washington | OTHER |
| Washington University School of Medicine | OTHER |
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Whole Blood - DNA Plasma Urine Vaginal Cultures (women) Perineal Cultures (men) Saliva
| Magnetic Resonance Imaging (MRI) | Procedure | One time MRI scanning session examining brain structure and function in a resting state and after water consumption. |
|
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| Multimodal Automated Sensory Testing System | Other | 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. |
|
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| Auditory Sensitivity Test | Other | Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device. |
|
| Iowa City |
| Iowa |
| 52242 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Duke University | Durham | North Carolina | 27715 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| 16148668 | Background | Bower 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. |
| 41944009 | Derived | Lai 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. |
| 39370868 | Derived | Helmuth 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. |
| 38717915 | Derived | Lai 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. |
| 37796776 | Derived | Mawla 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. |
| 34428922 | Derived | Harte 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. |
| 29288065 | Derived | Helmuth 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. |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D017288 | Pain Threshold |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D010146 | Pain |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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