What is the Optimal Technique for Hydrodistention? First Prospective Study Evaluating the Effect of Pressure, Duration and Number of Hydrodistentions on Patients with Interstitial Cystitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-month
研究概览
简要总结
This research study is being done to learn what is the best way to perform hydrodistention. Eligible participants will be enrolled and have follow-up for three months after surgery.
The study team hypothesizes that changes in hydrodistention technique, including pressure, number of distention, and duration of distention, leads to no or minimal changes in symptom improvement for patients with Interstitial cystitis/bladder pain syndrome (IC/BPS).
详细描述
Hydrodistention is a procedure designed to treat bladder and pelvic symptoms in patients with interstitial cystitis. A camera is placed inside the bladder and the bladder is filled with fluid. This procedure "resets" the signals between the bladder and brain, in order to reduce the symptoms of interstitial cystitis (such as bladder pain, urinary urgency/frequency/dysuria, incontinence, incomplete emptying, etc).
However, it is still unknown the best way to perform hydrodistention. Doctors do not know how much fluid to put in the bladder, how long to keep the fluid in the bladder, and how many times to fill the bladder.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and statistician blinded
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
- •Patients with IC/BPS who have failed first/second line treatments (behavioral therapy, medications) for greater than 3 months
- •Have not had hydrodistention performed in the past 3 months
- •Have not had botox or Percutaneous tibial nerve stimulation (PTNS) performed in the past 3 months
排除标准
- •Patients with known hunner's lesions
- •Patients with interstim
- •Patients with positive urinalysis/culture consistent with urinary tract infection (UTI)
- •History of urethral, bladder, prostate, uterine, cervical, vaginal cancer
- •History of augmentation cystoplasty or cystectomy
- •History of urethral diverticulum, urethral stricture, pelvic radiation
- •Patients with spinal cord injuries
- •History of dementia, parkinson's disease, multiple sclerosis, spina bifida, paraplegia/quadriplegia, cerebral palsy, stroke
- •Neurogenic bladder patients
- •Anuric patients
- •Tuberculous cystitis
- •Cyclophosphamide treatment
- •Pregnant patients
结局指标
主要结局
Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-month
时间窗: baseline to 1 month
Identify the optimal technique for hydrodistention, including the optimal pressure (30 vs 80cc), number of hydrodistentions (one vs two), duration of each hydrodistention (one vs two minutes) as quantified by Changes in the interstitial cystitis symptom index (ICSI)f rom baseline to 1-month. The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is usually experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
次要结局
- Number of morphine milligram equivalents (MME) given in the post-anesthesia care unit(After procedure (approximate time frame is 1 hour))
- Time spent in the post-anesthesia care unit (minutes)(After procedure (approximate time frame is 60 minutes))
- Complication rates between different hydrodistention parameters (pressure, number of distention, and duration of distention)(up to 30 days (after hydrodistention))
- Changes in the genitourinary pain index (GUPI) from baseline to 1- month(baseline to 1- month)
- Changes in the genitourinary pain index (GUPI) from baseline to 1-week(baseline to 1-week)
- Changes in the genitourinary pain index (GUPI) baseline to 3-months(baseline to 3-months)
- Changes in the interstitial cystitis symptom index (ICSI) from baseline to 1-week(baseline to 1-week)
- Changes in the interstitial cystitis symptom index (ICSI) from baseline to 3-months(baseline to 3-months)
研究者
James Clemens
Research Professor of Urology and Professor of Urology
University of Michigan