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Studie zur Anwendung eines pflanzlichen Kombinationspräparats bei Frauen mit Reizblase ("Overactive Bladder"-Syndrom). (Translation: Study with a herbal combination in women with the "overactive bladder" syndrome (irritable bladder)). - "femina-Studie" (Translation:femina-study)

Studie zur Anwendung eines pflanzlichen Kombinationspräparats bei Frauen mit Reizblase ("Overactive Bladder"-Syndrom). (Translation: Study with a herbal combination in women with the "overactive bladder" syndrome (irritable bladder)). - "femina-Studie" (Translation:femina-study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-002118-23-DE
Enrollment
Unknown
Registered
2008-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frequent micturition and urinary urgency, as common in patients suffering from overactive bladder syndrome. MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder

Interventions

Trade Name: GRANU FINK® femina Pharmaceutical Form: Capsule, soft INN or Proposed INN: Pumpkin seed oil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 227,3- INN o

Sponsors

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: •Women aged = 18 = 60 years •>= 8 micturions during 24 hours (average according diary over 3 days) •>= 1 episode of urge or urge incontinence in 24 hours (average according diary over 3 days) •overactive bladder symptoms consist since at least 3 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Diseases and conditions that may cause secondary irritable bladder or cause any other micturition complaints •Bladder cancer •Unexplained hematuria •Severe renal diseases •Severe hepatic diseases •Known hypersensitivity to ingredients of the study medication

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation, whether the use of this herbal preparation improves the symptoms of the overactive bladder syndrome, such as frequent micturition. ;Secondary Objective: Change of the frequency of urge and/or urge incontinence episodes Change of the Patient Perception of Bladder Condition (= PPBC) and Overactive Bladder-Questionaire (= OABq);Primary end point(s): Improvement of micturition frequency compared to baseline.—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026