Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study
NCT ID: NCT02485808
Last Updated: 2019-01-15
Study Results
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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COMPLETED
1879 participants
OBSERVATIONAL
2015-04-30
2018-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
None-observational
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.
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.
None-observational
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.
Controls
Men and women who are not experiencing lower urinary tract symptoms.
This group will undergo MRI, pain and auditory sensitivity testing.
Magnetic Resonance Imaging (MRI)
One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
Multimodal Automated Sensory Testing System
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 Test
Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.
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.
Magnetic Resonance Imaging (MRI)
One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
Multimodal Automated Sensory Testing System
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 Test
Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.
Interventions
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None-observational
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)
One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
Multimodal Automated Sensory Testing System
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 Test
Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. The presence of any of the symptoms reported in Table 1, based on responses to the LUTS Tool with a one month recall period.
4. The ability to give informed consent and complete self-reported questionnaires electronically.
Table 1: LUTS Appropriate for Study Inclusion
* Daytime frequency
* 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
Exclusion Criteria
2. 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.
3. Primary complaint is pelvic pain.
4. Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia.
5. Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
6. Current sexually transmitted infection. (deferral; subject can enroll after negative culture)
7. Ongoing symptomatic urethral stricture.
8. History of lower urinary tract or pelvic malignancy.
9. Current chemotherapy or other cancer therapy.
10. Pelvic device or implant complication (e.g., sling or mesh complications).
11. Current functioning neurostimulator.
12. Botox injection to the bladder or pelvic structures within the preceding 12 months.
13. In men, prostate biopsy in the previous 3 months.
14. In women, pregnancy.
15. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.
16. Augmentation cystoplasty or cystectomy.
17. Presence of urinary tract fistula.
18. Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.).
19. Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease).
20. Difficulty reading or communicating in English.
18 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Michigan
OTHER
Northwestern University
OTHER
Duke University
OTHER
University of Iowa
OTHER
University of Washington
OTHER
Washington University School of Medicine
OTHER
Arbor Research Collaborative for Health
OTHER
Responsible Party
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Principal Investigators
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Kevin P Weinfurt, PhD
Role: STUDY_CHAIR
Duke University
Claire Yang, MD
Role: STUDY_CHAIR
University of Washington
Robert M Merion, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Arbor Research Collaborative for Health - DCC
Locations
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Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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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.
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.
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. Erratum In: J Urol. 2005 Dec;174(6):2428.
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.
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.
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.
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.
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.
Related Links
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Study website
Other Identifiers
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LURN Phenotyping Study V8.0
Identifier Type: -
Identifier Source: org_study_id
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