Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- Change in Participant Bladder Pain Sensitivity From Baseline.
研究概览
简要总结
The purpose of this study is to determine if some women with dysmenorrhea (painful periods) are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives (OC) can be used to reverse this chronic pain risk.
Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected to reduce COS and decrease the risk of developing CPP.
详细描述
Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations producing moderate to severe pelvic pain in more than 20% of reproductive-age women. One out of every five of those women in turn will develop chronic pelvic pain (CPP), yet women without dysmenorrhea rarely report CPP. CPP disorders such as irritable bowel syndrome (IBS) and painful bladder syndrome (PBS) can cause severe, unrelenting pain due to a lack of effective treatments.
This study consists of 2 aims.
Aim #1: To determine if dysmenorrhea with concomitant bladder pain sensitivity exhibits neurophysiological features consistent with established CPP. Women with chronic pain or dysmenorrhea without COS will be used as controls. Quantitative sensory testing (QST) and a noninvasive bladder pain test that investigators validated previously be used to determine whether impairments in descending inhibition and pelvic sensitivity are responsible for vulnerability to COS in women with dysmenorrhea. EEG will be recorded to look for differences in brain activity in response to sensory stimulation between participants cohorts.
Aim #2: To differentiate the individual contributions of circulating sex hormones and repeated sensitizing events (painful menses) on descending and peripheral mechanisms of bladder pain. The same QST/bladder pain measures studied in Aim #1 will be retested within the dysmenorrhea+COS group following a one-year randomized trial of cyclical OCs vs. continuous OCs vs. no treatment. An observational arm of PBS participants will receive continuous OCs and serve as controls.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Reproductive age women (18-45)
- •For dysmenorrhea and D+COS group only:
- •Participants must have had regular (22-45 day) menstrual cycles over at least a two month period preceding testing
排除标准
- •presence of active pelvic or abdominal malignancies (primary or metastatic)
- •active genitourinary infection in the last four weeks
- •unable to read or comprehend the informed consent in English
- •unwilling to undergo pelvic examination/testing
- •presence of hypertension or risk for developing hypertension, and
- •For dysmenorrhea and D+COS group only:
- •absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding) unwilling to take either cyclic or combined OCs
- •unwilling to withdraw from OCs for two months prior to the sensory testing study visit.
研究组 & 干预措施
D+COS-cyclic microgestin 1/20
26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
干预措施: cyclic microgestin 1/20 (Drug)
D+COS-continuous microgestin 1/20
26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
干预措施: continuous microgestin 1/20 (Drug)
PBS-continuous microgestin 1/20
26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. QST will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
干预措施: continuous microgestin 1/20 (Drug)
结局指标
主要结局
Change in Participant Bladder Pain Sensitivity From Baseline.
时间窗: 0 (baseline), 6 month, and 12 month visits
Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the initial, 6 month and 12 month visits will be compared to determine if participants in each of the treatment groups had a reduction in pain. Bladder pain ratings at first urge will be used at the outcome measure.
次要结局
- Change in Quantitative Sensory Testing (QST) Parameters Regarding Pelvic Hyperalgesia From Baseline(0 (baseline), 6 months and 12 months)
- Differences in EEG Recorded Cortical Activity Among Participants(Baseline, 6 months and 12 months)
研究者
Frank Tu
Division Director, Gynecological Pain and Minimally Invasive Surgery, Department of Obstetrics and Gynecology
NorthShore University HealthSystem