跳至主要内容
临床试验/NCT02232282
NCT02232282已完成不适用

Acupuncture for Female Interstitial Cystitis/Painful Bladder Syndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial

Loyola University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome

研究概览

简要总结

The investigators central hypothesis is that women with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) will benefit from acupuncture compared with sham treatment and acupuncture responders will have a differential urinary microbiome.

详细描述

The Urinary Microbiota. Within internal surfaces, which are defined as existing outside the body (e.g. the intestinal epithelium or the vaginal epithelium), there exist commensal microbial communities. These microbiota are believed to be beneficial to human health, facilitating efficient removal of improperly functioning immune cells and protecting the host from pathogen infection13-15. The human bladder is a core component of the human urinary tract. It is a hollow muscular organ lined with transitional epithelium, which functions as the storage site for metabolic wastes in the form of urine. Given that the bladder's luminal space is also considered outside the body, it would seem reasonable that a urinary microbiota would be present. Yet, the historic dogma has maintained that urine is "sterile," based on culture-dependent methods of bacterial detection. This paradigm is shifting, however, based on our newly published data noting the presence of a urinary microbiota in adult women without clinical urinary tract infections16,17. Furthermore, we have recently discovered that the microbiota of women with overactive bladder (specifically with associated urgency incontinence) is distinguishable from the microbiota of women with stress urinary incontinence. These findings suggest that IC/PBS may be influenced by an alteration to the urinary microbiota. Indeed, recent evidence reports a difference in the urinary microbiome dominated by Lactobacillus in subjects with IC/PBS compared with healthy controls18. This work is limited by lack of correlative clinical symptomatology, small sample size and urinary samples that may have been contaminated.

The investigators long term goal is to determine pelvic pain mechanisms that will inform clinically-relevant classification and evidence-based treatment of women with IC/PBS and CPP. The short term goal of this application is to determine the safety, tolerability and efficacy of acupuncture in women with IC/PBS as a neuromodulative treatment and to correlate the urinary microbiome with acupuncture responders. Our approach will advance the understanding of the contribution and consequences of peripheral pelvic nociception in IC/PBS.

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 (Participant)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females, age 21 to 65 years
  • Symptoms of urinary frequency, urgency and suprapubic/bladder pain for > 6 months
  • Generally stable health
  • An average bladder pain score of at least >3/10

排除标准

  • Patients with pacemaker or other neurostimulator (gastric/spinal)
  • History or current symptomatic urethral stricture, cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy
  • Prior augmentation cystoplasty or cystectomy
  • Systemic autoimmune disorder (such as Crohn's Disease, Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis)
  • Systemic neuromuscular disease known to affect the lower urinary tract
  • History of urogenital cancer (with the exception of minor skin cancer)
  • Current or imminent planned pregnancy/recent delivery <6 months
  • Current pelvic floor physical therapy
  • Current use of opioid medications (short or long acting) for pain
  • Abdominal or pelvic surgery within the last 6 months.

结局指标

主要结局

Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome

时间窗: 0 weeks, 6 weeks

Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.

次要结局

  • Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome(0 weeks, 12 weeks)
  • Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom(0 weeks, 6 weeks)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Larissa Bresler

M.D.

Loyola University

研究点 (2)

Loading locations...

相似试验