Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study (LURN)

General Description

Lower urinary tract dysfunction (LUTD) is a condition related to the functions and/or structures of the lower urinary tract. LUTD affects both men and women, and becomes more common and frequent with age. Patients tend to exhibit a range of lower urinary tract symptoms (LUTS), but there has been a lack of understanding regarding which biological and psychosocial factors cause the symptoms to manifest and worsen. As a result, treatment and management methods for LUTS and LUTD have been unsatisfactory.

The Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study (LURN) was established to gain a better understanding of lower urinary tract symptoms in an effort to improve the lives of those with LUTD. LURN participants were enrolled at multiple sites within the United States. Participants were assigned to one of four subgroups, based on their symptoms, the outcomes of clinical assessments, and other characteristics. Biological samples were collected from study participants and participants were required to complete certain assessments and examinations at standard time-points during the study period.

MRI images for LURN participants are not included in the package, but are available upon request.

Objectives

The purpose of the Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study was to develop a framework for identifying and defining the subtypes of LUTS; create new questionnaires in order to improve the measurement of participant experiences of LUTS; and generate and share data, tools, and biological samples with clinical and research communities, in an effort to advance the understanding of LUTS and improve patients’ lives.

Outcome Measure

Study participants were regularly assessed for lower urinary tract symptoms and changes in lower urinary tract symptoms.

Criteria

Inclusion Criteria:
Study participants were age 18 and older; new patients of one of the LURN physicians; and experiencing lower urinary tract symptoms.

Exclusion Criteria:
Individuals were excluded from participation if they had difficulty reading or communicating in English; gross hematuria; were diagnosed with interstitial cystitis, chronic prostatitis, or chronic orchialgia; were pregnant; had a prostate biopsy in the three months prior to enrollment; pelvic or endoscopic genitourinary surgery, other than diagnostic cystoscopy, in the six months prior to enrollment; history of lower urinary tract or pelvic malignancy; history of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy; received a Botox injection to the bladder or pelvic structures within the 12 months preceding enrollment; had a current sexually transmitted infection; ongoing symptomatic urethral stricture; pelvic device or implant complication; current functioning neurostimulator; augmentation cystoplasty or cystectomy; undergoing chemotherapy or other cancer therapy; presence of urinary tract fistula; their primary complaint was pelvic pain; had a 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; or had a current major psychiatric disorder or other psychiatric or medical issues that would interfere with study procedures.

Outcome

This study has concluded, but the final outcomes have not been posted.