DRKS00009945已完成不适用
Observational study to collect data on treatment progression in women treated for bladder weakness (overactive bladder with or without incontinence) with GRANU FINK® femina - DCH/017714
Omega Pharma Innovation & Development NV0 个研究点目标入组 123 人开始时间: 2016年3月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 78 Years（—）
- 性别
- Female
入选标准
- •Recommended therapy with GRANU FINK® femina
- •Age 18-78 years
- •BMI 18.5 - 29.9 kg/m2
- •No existing pregnancy in women of childbearing potential (premenopausal women without surgical sterilization)
- •Women of child-bearing potential: currently uses reliable method of contraception
- •Willing and able to comply with diary and questionnaire completion
- •Written consent of the patient
排除标准
- •Known hypersensitivity to one of the product ingredients (e.g. hop, sumach bark, pumpkin seeds) or pumpkin-related plants as water melon, zucchini; soya, and peanut
- •Women only suffer on stress incontinence
- •Chronic or current cystitis
- •Untreated or non-stabilized diabetes (type I or II) or diagnosed within the last 6 months prior to study selection
- •Incontinence surgeries (e.g. colposuspension, sling placement)
- •Neurologic disease (e.g. multiple sclerosis, Parkinson’s disease, symptomatic herniated disc etc.)
- •Women of childbearing potential: pregnancy (current or within last 12 months) or breast-feeding
- •Descensus of bladder, uterus, and/or vagina
- •History of malignancy within 5 years prior to start of observation
- •Untreated or non-stabilised thyroid disorder
- •Any metabolic disease or other clinically significant disease/disorder which in the physician’s opinion could interfere with the results of the study or the safety of the patient
- •Patients who are not able to communicate with site study staff, or who are cognitively impaired, or unable to give informed consent
- •Intake of dewatering aids, and/or muscle relaxants within the last 3 months prior to study selection
- •Use of drugs for urinary incontinence/overactive bladder within the last 6 weeks prior to study selection
- •Use of any recreational drugs within the last 6 weeks prior to study selection
- •Use of anti-depressants within the last 6 weeks prior to study selection
- •Use of antibiotics within the last 6 weeks prior to study selection
研究者
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