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Идёт набор NCT05898932

Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes

Наблюдательное Benign Prostatic Hyperplasia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Medical Management, Surgical Management.
Кому может быть актуально
Состояния в реестре: Benign Prostatic Hyperplasia. Базовые параметры: от 50 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this project is to use newly developed patient-reported outcomes to improve the clinical care of patients with benign prostatic hyperplasia. The use of new patient-centered tools will improve evaluation and clinical decision-making by including symptoms not commonly measured in men, such as urinary incontinence, and allow for more frequent assessment of lower urinary tract symptoms through remote surveillance. Through the use of care-coordination checklists, clinicians can be more responsive to post-treatment symptom changes, resulting in reduced bother from lower urinary tract symptoms and higher quality of life in patients with benign prostatic hyperplasia.

Подробное описание

The American Urological Association Symptom Index (AUA-SI) has been the primary patient-reported outcome (PRO) used in men with benign prostatic hyperplasia (BPH) for decades. New symptom indices - the LURN SI-10 and LURN SI-29 - have been developed by the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) to provide a general-use multidimensional symptom assessment in the urology clinic. These tools are relatively new and have yet to be validated in specific disease populations. The overarching goal of this project is to use these new questionnaires to enhance clinical decision-making in men with BPH. This will be achieved by (1) integration of PRO assessments into the evaluation and management of patients with BPH; (2) determination of clinical meaningful differences in LURN symptom indices in men with BPH receiving known effective treatment; and (3) creation of data visualization tools and care-coordination recommendations to facilitate the matching of evidence-based treatments to patients with persistent symptoms using PROs. PROs provide a cost-effective remote management strategy that, combined with advances in electronic medical health record technology, can improve patient care by allowing for more real-time surveillance and intervention, and the monitoring of common comorbid symptoms such as sleep disturbance and depression, in addition to core urologic symptoms of BPH.

In Aim 1, the investigators will use sophisticated statistical methods to predict changes in urological symptoms and assess associations between lower urinary tract symptoms and measures of sleep, depression, and pain, among others. In Aim 2, the investigators will assess test-retest reliability and other psychometric properties of the LURN symptom indices, using a triangulation of methods to determine minimally important differences. Finally in Aim 3, the investigators will engage stakeholders, including patients and clinicians, and use qualitative methods to create visualization tools and care coordination checklists to improve counseling and follow up for patients undergoing treatment. Aim 3 will also enhance the recovery and routine monitoring of men with BPH after surgery, who can experience distressing side effects and complications such as urinary leakage and pain.

Вмешательства

  • Другое Medical Management
    Participants will be managing condition with medication
  • Другое Surgical Management
    Participants will be managing condition with a surgery

Первичные конечные точки

  • Patient rating of global change [Срок оценки: Through study completion, from week 4 to week 24]
  • LURN SYMPTOM INDEX-29 (LURN SI-29) [Срок оценки: The past 7 days]
  • The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1 [Срок оценки: The past 7 days]
  • AMERICAN UROLOGICAL ASSOCIATION (AUS) SYMPTOM SCORE [Срок оценки: The past 30 days]
Вторичные конечные точки (9)
  • Sexual Health Inventory for Men (SHIM) Questionnaire [Срок оценки: The past 6 months]
  • The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Diarrhea 6a [Срок оценки: In the past 7 days]
  • The Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.0 - Gastrointestinal Constipation 9a [Срок оценки: In the past 7 days]
  • Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) [Срок оценки: In the past month.]
  • The snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-Bang) questionnaire [Срок оценки: Not Applicable (NA)]
  • 3-Day Voiding Diary [Срок оценки: Recorded on three separate days]
  • The National Cancer Institute (NCI) Quick Food Scan [Срок оценки: in the past 12 months]
  • The Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function- Short Form 4a [Срок оценки: In the past 7 days]
  • The Patient Feedback Survey [Срок оценки: Immediate - This questionnaire is about survey burden in regard to the study]

Критерии участия

Критерии включения

  • Male sex
  • Age 50 years or older
  • Diagnosed by physician with BPH
  • Able and willing to complete questionnaires
  • Able and willing to provide informed consent
  • Ability to read, write, and speak in English
  • No plans to move from study area in next 6 months

Критерии исключения

  • Female sex or intersex
  • Younger than 50 years of age
  • Being a prisoner or detainee
  • Gross hematuria
  • Interstitial cystitis
  • Pelvic or endoscopic genitourinary surgery within the preceding 6 months (not including diagnostic cystoscopy)
  • History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy
  • Ongoing symptomatic urethral stricture
  • Current chemotherapy or other cancer therapy
  • History of lower urinary tract or pelvic malignancy
  • Severe neurological of psychiatric disorder that would prevent study participation (e.g., bipolar disorder, psychotic disorder, Alzheimer's Disease)
  • Current moderate or severe substance use disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • NorthShore University HealthSystem Research Institute — Glenview

Публикации

  • Glaser AP, Smith AR, Maglaque D, Helfand BT, Mohamed R, An H, Marquez M, Talaty P, Carolan P, Geller AM, Farina FR, Jensen SE, Griffith JW. Enhanced clinical decisions for management of benign prostatic hyperplasia using patient-reported outcomes: protocol for a prospective observational study. BMC Urol. 2024 May 21;24(1):110. doi: 10.1186/s12894-024-01500-0. PMID 38773430
  • Glaser AP, Smith AR, Maglaque D, Helfand BT, Mohamed R, An H, Marquez M, Talaty P, Carolan P, Geller AM, Farina FR, Jensen SE, Griffith JW. Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia using Patient-Reported Outcomes: Protocol for a Prospective Observational Study. Res Sq [Preprint]. 2024 May 6:rs.3.rs-4308293. doi: 10.21203/rs.3.rs-4308293/v1. PMID 38766034

Идентификаторы

NCT: NCT05898932 · STU00217126

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗