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Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study

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ClinicalTrials.gov Identifier: NCT02485808
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : January 15, 2019
Sponsor:
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
Information provided by (Responsible Party):
Arbor Research Collaborative for Health

Brief 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. 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.

Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Other: None-observational Procedure: Magnetic Resonance Imaging (MRI) Other: Multimodal Automated Sensory Testing System Other: Auditory Sensitivity Test

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

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Study Type : Observational
Actual Enrollment : 1879 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Phenotyping Study Protocol
Actual Study Start Date : April 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Other: 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.

Other: 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.

Procedure: Magnetic Resonance Imaging (MRI)
One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
Other Name: MRI

Other: 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.
Other Name: Pain Sensitivity

Other: 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.

Procedure: Magnetic Resonance Imaging (MRI)
One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
Other Name: MRI

Other: 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.
Other Name: Pain Sensitivity

Other: Auditory Sensitivity Test
Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in lower urinary tract symptoms [ Time Frame: baseline, 3 months, and 12 months ]

Biospecimen Retention:   Samples With DNA
Whole Blood - DNA Plasma Urine Vaginal Cultures (women) Perineal Cultures (men) Saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
New patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria (below).
Criteria

Inclusion Criteria:

  1. Men and women presenting for new patient visits for evaluation or treatment of LUTS to one of the LURN physicians.
  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:

  1. Gross hematuria.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485808


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27715
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Arbor Research Collaborative for Health
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
Investigators
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Study Chair: Kevin P Weinfurt, PhD Duke University
Study Chair: Claire Yang, MD University of Washington
Principal Investigator: Robert M Merion, MD, FACS Arbor Research Collaborative for Health - DCC
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arbor Research Collaborative for Health
ClinicalTrials.gov Identifier: NCT02485808    
Other Study ID Numbers: LURN Phenotyping Study V8.0
U01DK100017 ( U.S. NIH Grant/Contract )
U01DK100011 ( U.S. NIH Grant/Contract )
U01DK099932 ( U.S. NIH Grant/Contract )
U01DK099879 ( U.S. NIH Grant/Contract )
U01DK097780 ( U.S. NIH Grant/Contract )
U01DK097779 ( U.S. NIH Grant/Contract )
U01DK097776 ( U.S. NIH Grant/Contract )
U01DK097772 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to make IPD available.
Keywords provided by Arbor Research Collaborative for Health:
Lower Urinary Tract Symptoms
Bladder Symptoms
Overactive Bladder
Urinary Urgency
Lower Urinary Tract Dysfunction
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations