Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.
研究概览
简要总结
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.
详细描述
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating, incurable, and costly pain condition affecting approximately 3-8 million individuals in the United States and is extremely challenging to treat. Treatment advances in IC/BPS have stalled due to a lack of clear understanding of the condition, as symptoms and presentations vary widely. For these reasons, national organizations have prioritized the need to improve both treatment options and understanding of IC/BPS. Leading multi-institutional research networks have now identified that individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. At the same time, the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment. Growing evidence suggests that different phenotypes of patients with IC/BPS respond differently to medical intervention. The overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS. The investigator is proposing a randomized mechanistic trial to evaluate which participants may benefit from each treatment (Aim 1) and evaluate whether neurobiological mechanisms may moderate outcomes and change with treatment (Aim 2). The investigator hypothesizes that a prediction of which participants will respond preferentially to either form of treatment based on reported bodily pain distribution (pelvic pain primarily, pain outside of the pelvis). This project has great potential to tailor treatment and improve future IC/BPS precision-medicine care efforts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study assessors will be blinded to the study primary outcome but will be aware of study treatment conditions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older;
- •Diagnosis of IC/BPS as indicated by structured assessments;
- •Capable of giving written informed consent;
- •Able to enroll for the duration of the study period;
排除标准
- •Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke;
- •Current or history of diagnosis of primary psychotic or major thought disorder within the past five years;
- •Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years);
- •Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, active suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months;
- •Non-English speaking;
- •Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking;
- •Difficulties or limitations communicating over the telephone or via teleconferencing systems;
- •Any planned life events that would interfere with participating in the key elements of the study;
- •Any major active medical issues that could preclude participation;
- •Currently pregnant;
- •Currently being treated for cancer;
- •Cancer-related pain;
- •Recently or actively participating in treatment similar to those being investigated (e.g. individual psychotherapy or pelvic floor pt).
结局指标
主要结局
Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.
时间窗: Post-treatment (either Week 8 or 10)
GRA provides a global index used to rate the response of a condition to an intervention. The GRA is a 7-point centered scale that assesses patient impression of change in IC/BPS symptoms since entering the study ranging from 7= "very much worse" to 1= "very much improved." This scale will be administered at post-treatment and at follow-up. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will examine the mean differences in GRA scores by phenotype in each treatment condition, and we will then calculate the percentage of patients classified as treatment responders (GRA\<3) within each treatment and phenotype.
次要结局
- Quantitative Sensory Testing - Tolerance Average (QST-TOL)(Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24))
- Quantitative Sensory Testing - Threshold Average (QST-THR)(Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24))
- Urinary Nerve Growth Factor (NGF)(Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24))
- Chronic Overlapping Pain Condition-Screener (COPCS)(Baseline (Week 0))
- Interleukin-6, whole blood stimulated (IL6-LPS)(Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24))
- Quantitative Sensory Testing - Temporal Summation (QST-TS)(Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24))
- Urinary Interleukin-6 (IL6)(Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24))
研究者
Lindsey Mckernan
Associate Professor
Vanderbilt University Medical Center