Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485808
• Other study ID #: LURN Phenotyping Study V8.0
• Secondary ID: U01DK100017U01DK
• Status: Completed
• Start date: April 2015
• Est. completion date: May 2018

Study information

• Verified date: January 2019
• Source: Arbor Research Collaborative for Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1879
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Northwestern University	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	Washington University	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Arbor Research Collaborative for Health	Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, University of Iowa, University of Michigan, University of Washington, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Erratum in: J Urol. 2005 Dec;174(6):2428. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically relevant subgroups of patients with lower urinary tract symptoms	Identification of patient clusters based on their symptoms, clinical assessments, and/or other characteristics.	Baseline
Secondary	Change in lower urinary tract symptoms		baseline, 3 months, and 12 months

External Links

•   Study website