NCT01314781

Therapy of the Overactive Bladder Syndrome

Comparison of Solifenacin Combined With Pelvic Floor Muscle and Whole Body Vibration Training With Solifenacin Alone in Patients With Overactive Bladder Syndrome. - A Prospective Randomized Parallel Group Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Cantonal Hospital, Frauenfeld · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to investigate in patients with overactive bladder syndrome (OABS) whether a combination treatment of solifenacin with pelvic floor muscle training and whole body vibration training achieves a better treatment outcome than a treatment with solifenacin alone.

Detailed description

The treatment of patients with OAB in clinical practice often consists of drug therapy in combination with bladder training and/or behavioural therapies such as whole body vibration training (WBVT) and pelvic floor muscle training (PFMT). However, very little data exist on the benefits of such combinations. In particular, there are not data on the association of antimuscarinic agents with both WBVT and PFMT. In order to optimize the treatment of OAB it is of great importance to conduct studies which compare pharmacotherapy alone with a combination of pharmacotherapy and behavioural techniques. The aim of the present study is to investigate in patients with OABS whether a combination treatment of solifenacin with pelvic floor muscle training and whole body vibration training achieves a better treatment outcome than a treatment with solifenacin alone. At the baseline visit subjects will be randomised into 2 treatment arms. Patients randomized to group A will receive solifenacin 5mg tablet once daily and a training programme for PFMT and WBVT once a week. Subjects randomised to group B will receive solifenacin 5mg tablet once daily. Efficacy evaluation will take place at week 8 and 16. Safety evaluations will take place at each visit. At week 8, after discussion with the investigator, the patient will have an option to continue with the original dose or request a dose increase based on their satisfaction of efficacy and tolerability.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	solifenacin	solifenacin 5mg tablet once daily
PROCEDURE	PFMT and WBVT	pelvic floor muscle and whole body vibration training once a week

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2015-03-01
• First posted: 2011-03-15
• Last updated: 2016-05-20

Locations

1 site across 1 country: Switzerland