A Study of Quality of Life and Changes to Symptom Relief for Acute Uncomplicated Cystitis Treated With Antibiotics (Ciprobay); Prospective, Open-label, Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Effect on patient satisfaction and quality of life.
研究概览
简要总结
Although Cystitis includes a clinical syndrome characterized by various combinations of dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been little research on Clinical aspects on cystitis treatment such as bothersomeness, or the impact of symptoms on patients' quality of life (QoL). The investigators want to study for Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay) in Acute Uncomplicated Cystitis in Korean Women.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female outpatients (20-65 years old)
- •Acute cystitis symptoms (subject-reported) for < 1 week prior to Visit 1.
排除标准
- •Acute cystitis symptoms for ≥ 1 week prior to Visit
- •Diabetes mellitus
- •Congenital urinary tract abnormality
- •Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study.
- •Hypersensitivity to the active substance (Ciprobay).
- •Subjects who have vaginal discharge
- •Fever ( ≥ 37.5 ºC)
- •Sexually transmitted diseases.
- •Documented significant renal disease (sCr > 1.5)
- •Subjects who cannot consent to this study.
- •Subjects who had received antimicrobial agents in the previous 4 weeks.
- •Recurrent urinary tract infection defined as treatment for UTI > 3 times in the last year.
- •Use of an indwelling catheter or an intermittent self-catheterization program.
- •Neurogenic bladder.
研究组 & 干预措施
Cystitis
female with cystitis symptoms
干预措施: Ciprobay (Drug)
结局指标
主要结局
Effect on patient satisfaction and quality of life.
时间窗: at day 5 relative to baseline
次要结局
- Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria)(at day 10, 21 and 28 relative to baseline)
- Change in KHQ(at day 10, 21 and 28 relative to baseline)
研究者
Kwang-Woo Lee, MD
Department of urology
Soonchunhyang University Hospital