Therapy of the Overactive Bladder Syndrome (TOBS)

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: solifenacin; Procedure: PFMT and WBVT

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Thurgau
    • Frauenfeld, Thurgau, Switzerland, 8501
      • Blasenzentrum, Cantonal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female patients with symptoms of overactive bladder (urinary frequency and urgency with or without incontinence) for ≥ 3 months
• Age ≥ 18 years old
• Urinary frequency ≥ 8 micturitions on average per 24 hours during the 3-day micturition diary period
• At least 3 episodes of urgency with or without incontinence (≥ 3) during the 3-day micturition diary period
• Patient provides written informed consent
• Patient is willing to complete the micturition diary

Exclusion Criteria:

• Clinically significant bladder outflow obstruction at risk of urinary retention (at the discretion of the investigator)
• Significant post void residual volume (> 200ml)
• Uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contraindicated
• Neurological cause of abnormal detrusor activity
• Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study
• Current non-drug treatment including pelvic floor muscle and whole body vibration training
• Known contraindications for whole body vibration training (cardiovascular, neurological or orthopaedic diseases, diabetes, tumor, pacemaker)
• Pregnant women or women who intend to become pregnant during the study
• Known or suspected hypersensitivity to solifenacin or lactose
• Concomitant use of a strong cytochrome P450 3A4 inhibitor (e.g. ketoconazole)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: solifenacin 5mg, PFMT and WBVT; Patients randomized to group A will receive solifenacin 5mg tablet once daily and a training programme for PFMT and WBVT once a week.	Drug: solifenacin; solifenacin 5mg tablet once daily; Other Names: brand name: vesicare; Procedure: PFMT and WBVT; pelvic floor muscle and whole body vibration training once a week; Other Names: Galileo; Pelvic Floor Muscle Training; Whole Body Vibration Training
Active Comparator: solifenacin 5mg; Subjects randomised to group B will receive solifenacin 5mg tablet once daily.	Drug: solifenacin; solifenacin 5mg tablet once daily; Other Names: brand name: vesicare

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of patient perception of bladder condition (PPBC)	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.	baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in micturitions/24h based on a 3-day micturition diary	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.	baseline and 16 weeks
Change of urgency episodes (grade ≥3) /24h	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.	baseline and 16 weeks
Change in volume voided per micturition	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.	baseline and 16 weeks
Change in number of incontinence and urge incontinence episodes/24h	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.	baseline and 16 weeks
Change in number of pads used/24h	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.	baseline and 16 weeks

Collaborators and Investigators

• Sponsor: Cantonal Hospital, Frauenfeld
• Collaborators: Astellas Pharma Inc
• Investigators: Principal Investigator: Volker VV Viereck, physican, Cantonal Hospital, Frauenfeld

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Overactive Bladder; urinary frequency
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: SOL-OAB-01-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO