Lower Urinary Tract Symptoms Clinical Trial
Official title:
Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Phenotyping Study Protocol
Verified date | January 2019 |
Source | Arbor Research Collaborative for Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
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 |
United States,
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
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 |
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