Lower Urinary Tract Symptoms Clinical Trial
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.
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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