Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Bladder Capacity
研究概览
简要总结
The investigators observed 12 fibromyalgia and interstitial cystitis patients undergoing hyperbaric oxygen oxygen treatment in a multiplace pressure chamber for 90 minutes, 40 treatment each, using an oro-nasal mask.
详细描述
The investigators structured a prospective observational pilot experimental design in consenting patients with IC and FM, with repeated subjective and urological measures conducted before and after a therapeutic protocol. The study duration was set to 3 months. Patients were exposed to breathing 100% oxygen at 2 atmospheres absolute (ATA) in a multiplace pressure chamber for 90 minutes using an oro-nasal mask. Patients undertook a cycle of 20 sessions for 5 days per week for four weeks. After one week of suspension, a second cycle of 20 sessions was completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Presence of absence of Hunner's ulcers
- •Pain in bladder that improves with urination
- •pain(supra-pubic, pelvic, urethral, vaginal, or perineal)
- •presence of glomerulation or bleeding +/- at the cystodistension
- •reduced capacity
- •increased proprioceptive sensitivity
- •normal or reduced compliance
- •number of tender points that establish that diagnosis
排除标准
- •Pregnancy (diagnosed or within a year)
- •age less than 18 years
- •benign or malignant bladder tumors
- •radiation cystitis
- •symptomatic bladder diversions
- •herpes in active phase
- •bladder and urethral stones
- •urinary frequency less than 10 times a day
- •presence of symptoms less than 12 months
- •bladder capacity>400ml with no sensitive urgency
结局指标
主要结局
Bladder Capacity
时间窗: 1-3 months after completing procedure
O'Leary Saint Index: measures the symptoms of the lower urinary tract and their influence on quality-of-life in subjects with IC. Scales range from 0-5 in most cases, with 0 being indicative of little to no symptoms and higher numbers indicative of more severe symptomatology.
Frequency of Urination
时间窗: 1-3 months after completing procedure
Frequency of Urination was measured via a voiding diary. Patients recorded all urinary events via the voiding diary.
Pain symptoms in IC patients
时间窗: 1-3 months after completing procedure
Widespread Pain Index (WPI): total amount ranges from 0 to 19 points corresponding to the possibly-painful 19 body areas (i.e., areas of the shoulders, arms, hips, legs, jaws, chest, abdomen, back, and neck).
Pain Symptoms in IC patients
时间窗: 1-3 months after completing procedure
Pelvic Pain \& Urgency and Frequency Symptom Scale (PUF: Total scores range from 0-35 (symptom subscale 0-23 and bother subscale 0-12). The higher the scores, the more severe the level of symptoms.
Bladder Capacity (as part of symptoms)
时间窗: 1-3 months after completing procedure
Symptom Severity Scale (SSS): symptoms are measured on the basis of a 0-3 severity scale considering fatigue, waking unrefreshed, and cognitive symptoms. The greater the amount, the more severe the symptomatology.
次要结局
未报告次要终点