Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared Guided Ultrasound Gel, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- NRS score
研究概览
简要总结
This is a randomized controlled trial. One group (intervention group) will get in advance to the prostate biopsy rectal approximately 5 cc Instillagel. And one group (control group) will get in advance to the ultrasound -guided prostate biopsy rectal gel. Pain is measured using the Numerical Rating Scale (NRS). The NRS is an imaginary line from 0 until 10. The 0 is no pain and 10 is most worst imaginable pain.
详细描述
Urologist within Rijnstate use both Instillagel and ultrasound gel during prostate biopsy. According to the protocol, the ultrasound-guided prostate biopsy must be performed using ultrasound gel. Some urologists departed from the protocols because they think that Instillagel will give a pain reduction. With this research we investigate whether Instillagel will have an effect on the pain perception bij the patients.
There will be three moments of pain measurements; Prior to het prostate biopsy. Immediately after the prostate biopsy. And five to thirty minutes after the prostate biopsy, when the patient is dressed and before the patient goes home.
Primary endpoint Pain measured by the Numeric Rating Scale
Secondary endpoints
- Age of patient
- Previous prostate biopsy
- The number of biopsies taken
- Presence of prostate cancer
- Other complications as after prostate biopsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •outpatient ultrasound guide prostate biopsy
- •> 40 years old.
- •Good knowledge of dutch language
排除标准
- •coagulation disorders
- •disorders of the rectum like hemorrhoids, anal fistula, proctitis, rectal polyps and rectal cancer.
- •treated for active urinary tract infection
- •known of allergy to lidocaine
- •taking antidepressants
- •using anaesthetic agents
- •neurological disorders such as Parkinsons disease, hernias and spinal cord injury
- •treated with radiotherapy for prostate cancer
结局指标
主要结局
NRS score
时间窗: Three measurements before, just after and 5 -30 minutes after procedure
次要结局
- age of patient(Two weeks after the prostate biopsy.)
- Previous prostate biopsy(Two weeks after the prostate biopsy.)
- Other complications as after prostate biopsy(two weeks after prostate biopsy)
- The number of biopsies taken(two weeks after prostate biopsy)