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2016年3月9日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- bladder weakness (overactive bladder with or without incontinence)
- 发起方
- Omega Pharma Innovation & Development NV
- 入组人数
- 123
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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