Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Urinary Urgency Phenotyping Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,030
- 试验地点
- 7
- 主要终点
- Change in lower urinary tract symptoms
研究概览
简要总结
The purpose of this study is to define and characterize important subtypes of patients with urinary urgency to improve our understanding of the pathophysiology, risk factors, experiences, and comorbidities to lay the foundation for more effective treatment by focusing on the most bothersome and difficult to treat symptoms of urinary urgency and urgency urinary incontinence.
详细描述
LURN is pursuing deeper phenotyping of patients with urinary urgency and UUI using distinct, but related, projects. The Urinary Urgency Phenotyping Protocol is the overarching effort, and will comprise five integrated projects. Project A, the Observational Cohort, will be a large-scale accrual of male and female participants with urinary urgency and age-matched controls without any LUTS. Standardized clinical data, comprising information typically gathered at the patient clinic encounter, self-report symptom, urologic and non-urologic data, and biosamples will be collected. Using this group of participants, subsets will be identified for more focused and in-depth studies of urinary urgency and urgency incontinence. This more focused effort will be conducted as Project B: the Central Sensitization Study; Project C: the Physical Activity and Sleep Study; Project D: the Organ-Based Study; and Project E: the Qualitative Assessment of Patients with Urinary Urgency Study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women or men presenting for evaluation or treatment of urinary urgency/ UUI to one of the LURN sites. These symptoms are not required to be the primary symptom(s) of presentation, but must be bothersome to the participant.
- •Age ≥ 18 years.
- •The presence of any of the urinary urgency or urgency incontinence symptoms based on responses to the LUTS Tool with a 1-month recall period (Appendix A) as follows:
- •Answered "sometimes", "often", or "always" on either:
- •"During the past month, how often have you had a sudden need to rush to urinate?". Participants who answered "never" or "rarely" are not eligible since they are not deemed to have significant urinary urgency symptoms.
- •"How often have you had a sudden need to rush to urinate for the fear of leaking urine?"
- •Positive answer must also be associated with bother rating on that particular question of "somewhat", "quite a bit", or "a great deal"
- •The ability to give informed consent and complete self-reported questionnaires electronically.
- •Access to and willingness to utilize smart phone
排除标准
- •a. Clinical impression of bladder outlet obstruction (based on symptoms or urodynamics) as primary etiology of LUTS.
- •b. Gross hematuria/self-reported gross or visible urine in the blood. c. 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.
- •d. Primary complaint is pelvic pain. e. Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchalgia.
- •f. Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
- •g. Ongoing symptomatic urethral stricture. h. History of LUT or pelvic malignancy. i. Current chemotherapy or other cancer therapy. j. Pelvic device or implant complication (e.g., sling or mesh complications). k. In men, prostate biopsy in the previous 6 months. l. In women, current pregnancy or planned pregnancy during the follow-up period.
- •m. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.
- •n. Augmentation cystoplasty or cystectomy. o. Presence of urinary tract fistula. p. Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.).
- •q. Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease).
- •r. Difficulty reading or communicating in English. s. No access to internet/smart phone. t. Indwelling Foley catheter/routine self-catheterization. u. In addition to the criteria listed above, pregnancy during the study will be a study end point.
研究组 & 干预措施
Organ-Based Study
Women enrolled in the Prospective Observational Cohort Study with urinary urgency, with and without urgency incontinence.
干预措施: Organ-Based (Other)
Physical Activity and Sleep Study Controls
Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
干预措施: Physical Activity and Sleep Tracker Controls (Other)
Organ-Based Study Controls
Women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency pr urgency incontinence.
干预措施: Organ-Based (Other)
Qualitative Assessment of Patients with Urinary Urgency Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency who have treatment plans prescribed at the baseline visit.
干预措施: Qualitative Assessment of Patients with Urinary Urgency (Other)
Prospective Observational Cohort Study
Men and women with lower urinary tract symptoms.
干预措施: Observational (Other)
Prospective Observational Cohort Study Controls
Men and women who do not have urinary dysfunction.
干预措施: Observational Controls (Other)
Central Sensitization Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
干预措施: Central Sensitization (Other)
Central Sensitization Study Controls
Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
干预措施: Central Sensitization (Other)
Physical Activity and Sleep Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
干预措施: Physical Activity and Sleep Tracker (Other)
结局指标
主要结局
Change in lower urinary tract symptoms
时间窗: Baseline, 3 months, 6 month, 9 months,12 months
Participants will be classified as treatment responders if they achieve at least a 10-point reduction from baseline on the OAB-q and/or respond "much better" or "very much better" on the PGI-I
次要结局
- Examine the presence of sensory hypersensitivity in urinary urgency (with or without urgency incontinence)(Baseline)
- Assess the relationship between physical activity and sleep quality in men and women with bothersome urinary urgency(Baseline and 3 months)
- The role of the urethra and its interaction with the bladder in LUT function and dysfunction(Baseline)