Multicenter Clinical Study of the Efficacy and Tolerability of INSTYLAN (Sodium Hyaluronate 80mg/50ml) in Patients With Early or Late Symptoms of Moderate to Severe Hemorrhagic Cystitis Caused by Pelvic Radiation Therapy and/or Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 20
- 主要终点
- Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7
研究概览
简要总结
The purpose of this study is to assess the efficacy and tolerability of INSTYLAN (Sodium Hyaluronate 80mg/50ml) in Patients with early or late symptoms of moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy. The study is conducted in the field of routine clinical practice and will recruit 30 subjects treated with intravesical instillations with INSTYLAN weekly for 6 weeks.
详细描述
This is a multicenter single-arm clinical study including male and female subjects with moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy as determined by the physician. A total of 30 subjects are anticipated and will be enrolled in 10 study sites in France.
The patients will receive intravesical instillations with INSTYLAN weekly for 6 weeks.
The objectives of the study are to assess the efficacy of intravesical instillations of INSTYLAN on the basis of hemorrhagic cystitis symptoms disappearance. The primary endpoint is the evaluation of pain using a verbal rating scale one week and four weeks after treatment versus Baseline.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, at least 18 years,
- •Patients who provided signed written informed consent, which includes compliance with requirements listed in the consent form,
- •Patients with diagnosis of Hemorrhagic Cystitis,
- •Patients with diagnosis of bladder pain (pressure or pelvic discomfort) with at least one other urinary symptom (need to urinate right away (urgency), often (frequency), or both).
排除标准
- •Patients with Post-void residual (PVR) urine volume > 200ml,
- •Patients presently treated with intravesical treatment (replenishment therapy with glycosaminoglycans),
- •Patients receiving HyperBaric Oxygen Therapy (HBOT),
- •Patients with neurogenic bladder,
- •Patients treated with neuromodulation techniques within the last six months,
- •Patients undergoing or scheduled for radiation therapy, brachytherapy, chemotherapy or treatment with BCG or with Mitomycin-C,
- •Patients suffering from lower urinary infections (UTIs),
- •Patients with unstable cardiovascular disease,
- •Patients with any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
结局指标
主要结局
Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7
时间窗: Week 7
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 10
时间窗: Week 10
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
次要结局
- Evaluation of number of micturitions / 24 hours(Baseline, week 7 and week 10)
- Evaluation of hematuria following a rating scale(Baseline, week 7 and week 10)
- Evaluation of urgency of micturitions following a rating scale(Baseline, week 7 and week 10)