Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 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 goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder pain sensitivity change from baseline after reduced menstrual pain experience over six months. Finally, a battery of quantitative sensory tests and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with improvements in menstrual and bladder pain.
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 experience chronic pelvic pain (CPP) which may be in part due to cross-organ neural sensitization.
In this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than *** use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Reproductive-age women (age 18-45) with dysmenorrhea
- •Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers
- •Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament
- •Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs)
排除标准
- •Presence of active pelvic or abdominal malignancies (primary or metastatic)
- •Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding)
- •Active genitourinary infection in the last four weeks
- •Unable to read or comprehend the informed consent in English
- •Unwilling to complete study procedures
- •Presence of hypertension or risk for developing hypertension
- •Unwillingness to take naproxen and/or placebo
- •Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function)
- •Formal urological diagnosis such as overactive bladder or bladder pain syndrome.
研究组 & 干预措施
Primary Dysmenorrhea
We will look at the effects of naproxen 500mg use on pain starting just before and during menses.
干预措施: Naproxen (Drug)
结局指标
主要结局
Change in Participant Bladder Pain Sensitivity From Baseline
时间窗: 6-8 months
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 baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure.
Change in Menstrual Pain
时间窗: 6-8 months
Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score.
次要结局
未报告次要终点
研究者
Frank Tu
Division Director MIS/Clinical Professor
NorthShore University HealthSystem