A Prospective Trial Comparing the Response to Hyperbaric Oxygen Treatment in Patients With Ulcerative and Non-Ulcerative Interstitial Cystitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Global Response Assessment (GRA)
研究概览
简要总结
To review the results of Hyperbaric Oxygen therapy (HBOT) on the symptoms of interstitial cystitis (IC). To determine if there is greater symptom improvement in the ulcerative vs the non-ulcerative patients with interstitial cystitis.
详细描述
There are multiple published studies outside of the United States on HBOT for treatment of interstitial cystitis. None of these studies compares ulcerative IC and non-ulcerative IC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Interstitial cystitis.
- •Urinary frequency of at least 8 times per 24 hours period.
- •Patients with ulcerative IC must have undergone previous biopsy negative for cancer.
- •Patients must agree to not begin any additional treatment for IC until study completion.
排除标准
- •Absolute or relative contraindication to hyperbaric oxygen treatment.
- •Patients dependent on intermittent catheterization or indwelling catheter to empty bladder.
- •Any imminent change in residence, which could compromise compliance.
- •Unlikely to be compliant due to unmanaged medical or psychological problems.
- •Severe debilitating concurrent medical conditions.
- •A history of pelvic radiation, bladder stone, bladder cancer or cancer in situ, or urethral cancer.
- •Precious bladder or neurologic surgery which has affected bladder function.
- •Currently has an active urethral stone, ureteral stone or urethral diverticulum.
- •Subject misses more than 10 treatments.
- •Severe claustrophobia.
结局指标
主要结局
Global Response Assessment (GRA)
时间窗: 3 months post treatment
The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they received hyperbaric oxygen therapy (HBOT). Responses are: 1 Markedly Worse, 2 Moderately Worse, 3 Mildly Worse, 4 Unchanged, 5 Mildly Better, 6 Moderately Better and 7 Markedly Better.
次要结局
未报告次要终点
研究者
Kenneth Peters, MD
Principal Investigator
William Beaumont Hospitals