Observational study to collect data on treatment progression in women treated for bladder weakness (overactive bladder with or without incontinence) with GRANU FINK® femina
- Conditions
- bladder weakness (overactive bladder with or without incontinence)
- Registration Number
- DRKS00009945
- Lead Sponsor
- Omega Pharma Innovation & Development NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 123
• Recommended therapy with GRANU FINK® femina
• Women
• 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
• 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method