Therapy of the Overactive Bladder Syndrome (TOBS)

• Change of patient perception of bladder condition (PPBC) [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

  The primary efficacy parameter is the change from baseline in mean score of patient perception of bladder condition (PPBC). Between-treatment differences in changes from baseline to endpoint will formally be tested using an analysis of variance (ANOVA).

  For the primary efficacy parameter, statistically significant superiority of solifenacin combined with pelvic floor muscle training (PFMT) and whole body vibration training (WBVT) to solifenacin alone must be obtained.

  
  

• Change in micturitions/24h based on a 3-day micturition diary [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

  The analysis as described for the primary endpoint will be also applied for the secondary variables:

  Change from baseline in mean score of number of micturitions/24h based on a 3-day micturition diary.

  
  
• Change of urgency episodes (grade ≥3) /24h [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

  The analysis as described for the primary endpoint will be also applied for the secondary variables:

  Change from baseline in mean number of urgency episodes (grade ≥3) /24h.

  
  
• Change in volume voided per micturition [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

  The analysis as described for the primary endpoint will be also applied for the secondary variables:

  Change from baseline in mean volume voided per micturition.

  
  
• Change in number of incontinence and urge incontinence episodes/24h [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

  The analysis as described for the primary endpoint will be also applied for the secondary variables:

  Change from baseline in mean number of incontinence and urge incontinence episodes/24h.

  
  
• Change in number of pads used/24h [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

  The analysis as described for the primary endpoint will be also applied for the secondary variables:

  Change from baseline in mean number of pads used/24h.

  
  

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.