Pilot study to investigate the effects of a herbal combination in women suffering from overactive bladder syndrome

Phase 4

• Conditions: N32.8; Other specified disorders of bladder

• Registration Number: DRKS00000268
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-19
• Study Completion: 2010-08-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

Overactive bladder symptoms persist since at least three months; overactive bladder symptoms have not been treated within two weeks before screening visit; maximum Body Mass Index of 30; eight micturitions minimum within 24 hours; one episode of urge or urge incontinence minimum within 24 hours.

Exclusion Criteria

Known hypersensitivity to pumpkin seed and related plants such as watermelon, courgette etc, to soy, peanut or any other of the ingredients of the study medication; hereditary fructose intolerance or glucose-galactose malabsorption; urinary retention; diseases causing micturition disorders; bladder cancer; urinary tract infection (acute or within four weeks before the first study visit); isolated nocturia; unexplained hematuria; neurological diseases; preceding surgeries in lower urinary tract and all other medical interventions (e.g. hysterectomy), that may cause urinary incontinence; preceding irradiation; diabetes mellitus (HbA 1c >6), endocrinologic disorders; preceding venereal disease; depression; diseases causing severe cough or sneezing and chronic pressure on pelvic floor; pregnant or breast-feeding women, women of childbearing potential and who do not maintain effective contraception during the study; severe renal or hepatic diseases; concomitant medication or treatment that may influence bladder function.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of micturition frequency after eight weeks of treatment compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Change of micturition frequency in the course of eight weeks of treatment compared to baseline. || Change of urge frequency in the course of eight weeks of treatment compared to baseline. || Change in Quality of Life mesaured by use of questionnaires at baseline and after 1, 4 and 8 weeks of treatment.