Real-world Evidence Observational Study to Evaluate Performance and Safety of Intravesical Sodium Hyaluronate (Cystistat®) in the Treatment of Patients With Interstitial Cystitis (IC) / Bladder Pain Syndrome (BPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Patient Global Assessment (PGA)
研究概览
简要总结
This study will be conducted with the aim of ensuring the continued acceptability of the benefit-risk ratio and confirming the safety and performance of the device throughout its expected lifetime. Cystistat is supplied as a 50 mL solution containing 40 mg of sodium hyaluronate. It is indicated for the temporary replacement of the GAG layer in the bladder.
详细描述
Real-world evidence observational studies are considered as an expedient tool to reflect the use of a product under real life conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First prescription of Cystistat according to instructions for use.
- •Female patients of any ethnic origin with clinical diagnosis of interstitial cystitis (IC)/bladder pain syndrome (BPS). If in accordance with routine clinical practice at the site, ESSIC diagnostic criteria will be used.
- •Age: 18 years and older.
- •At least 6 months duration of bladder pain/discomfort symptom(s), e.g. constant bladder pain/discomfort or bladder pain/discomfort when voiding or as a burning sensation between voids as the bladder fills with urine.
- •At least one accompanying intermittent or persistent lower urinary tract symptom, such as urinary frequency, urgency, or nocturia during the previous 6 months.
- •Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) > 18 prior to first treatment.
- •Written informed consent.
排除标准
- •Known hypersensitivity reactions to sodium hyaluronate.
- •Pregnancy / planned pregnancy or breastfeeding during the course of this NIS.
- •Known history of any GAG substitution therapy within the last 2 years.
- •Known history of fulguration or resection of Hunner's lesions.
- •Known diagnosis of recurrent urinary tract infection or overactive bladder.
- •Any other conditions or diseases that can cause similar symptoms, using information from medical history, physical examination findings, laboratory studies (e.g., urine bacterial culture), and other previously performed procedures (e.g., urodynamics, cystoscopy, laparoscopy, radiological studies).
- •Patients are not able to fulfil study requirements according to physician's opinion.
结局指标
主要结局
Patient Global Assessment (PGA)
时间窗: Up to week 12
For the primary analysis, a responder was defined as a participant who had an improvement on the PGA scale (i.e., PGA evaluated as markedly improved, moderately improved, or slightly improved. In case of slightly improved, participants were considered as responder only if the question "Did therapy have a positive effect on your life, and would you undergo this treatment again?" is answered with "Yes".).
次要结局
- Assessment of Bladder Pain/ Interstitial Cystitis Symptom Score(Up to week 12 and additionally at Month 6)
- Assessment of Visual Analogue Scale (VAS) for Bladder Pain(Up to week 12 and additionally at Month 6)
- Assessment of Visual Analogue Scale (VAS) for Urinary Urgency.(Up to week 12 and additionally at Month 6)
- Assessment of Visual Analogue Scale (VAS) for Quality of Life (QoL)(Up to week 12 and additionally at Month 6)