Clinical trial NCT02485808: Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study
Official title: Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Phenotyping Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Keywords: Lower Urinary Tract Symptoms
Bladder Symptoms
Overactive Bladder
Urinary Urgency
Lower Urinary Tract Dysfunction
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Michigan
name: Northwestern University
name: Duke University
name: University of Iowa
name: University of Washington
name: Washington University School of Medicine
First posted: 2015-06-30
Enrollment: 1879
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Eligibility 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.

Primary outcomes:
measure: Clinically relevant subgroups of patients with lower urinary tract symptoms
timeFrame: Baseline
Secondary outcomes:
measure: Change in lower urinary tract symptoms
timeFrame: baseline, 3 months, and 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Duke University
name: Kevin P Weinfurt, PhD
role: STUDY_CHAIR
affiliation: University of Washington
name: Claire Yang, MD
role: STUDY_CHAIR
affiliation: Arbor Research Collaborative for Health - DCC
name: Robert M Merion, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.