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)

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

• Registration Number: EUCTR2008-002118-23-DE
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-25
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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