NCT02485808

Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study

Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Phenotyping Study Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,879 (actual)
• Sponsor: Arbor Research Collaborative for Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.
PROCEDURE	Magnetic Resonance Imaging (MRI)	One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
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	Auditory Sensitivity Test	Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-04-01
• Completion: 2018-05-01
• First posted: 2015-06-30
• Last updated: 2019-01-15

Locations

6 sites across 1 country: United States