bladder weakness (overactive bladder with or without incontinence)
Conditions
Interventions
Group 1: - Traditional Herbal Medicinal Product: Granu Fink® femina
- Ingredients:
Pumpkin seed oil 227.3 mg
Dry extract from fragrant sumach bark (5-7 : 1)
Extractant: water 56.0 mg
Dry extract from
Sponsors
Omega Pharma Innovation & Development NV
Eligibility
Sex/Gender
Female
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study objective is to gain additional information about treatment progression under routine medical practice with GRANU FINK® femina by assessing: • Changes in micturition frequency (number of micturitions at each visit and at study end (= end of observation/after 12 weeks) compared to baseline (= start of observation/documentation)), including: o Changes in daytime micturition frequency (micturition diary) o Changes in nighttime micturition frequency (micturition diary) • Changes in urge micturition (sensation as well as number of leaks/pads) at each visit and at study end, each compared to baseline (micturition diary) • Changes in symptoms assessed per questionnaires (ICIQ-OAB) at each visit and at study end, each compared to baseline • Evaluation of health related quality of life assessed per questionnaire (ICIQ-OABqol) at each visit and at study end, each compared to baseline • Insights about the application modalities (CRF) • Global evaluation of treatment success by the patients and physicians at study end (CRF) • Global evaluation of satisfaction by the patients at study end (CRF) • Additionally, safety and tolerability of treatment with GRANU FINK® femina during routine medical practice evaluated by assessing: • Occurrence of adverse events / adverse drug reactions throughout the study (CRF) • Global evaluation of tolerability by the patients and physicians at study end (CRF) • Global evaluation of compliance by physicians at study end (CRF) | — |
Countries
Germany
Contacts
Public ContactRalf Uebelhack
Outcome results
None listed