Therapy of the Overactive Bladder Syndrome

NCT ID: NCT01314781

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

solifenacin

Intervention Type: DRUG

solifenacin 5mg tablet once daily

PFMT and WBVT

Intervention Type: PROCEDURE

pelvic floor muscle and whole body vibration training once a week

solifenacin 5mg

Subjects randomised to group B will receive solifenacin 5mg tablet once daily.

Group Type: ACTIVE_COMPARATOR

solifenacin

Intervention Type: DRUG

solifenacin 5mg tablet once daily

Interventions

solifenacin

solifenacin 5mg tablet once daily

Intervention Type: DRUG

PFMT and WBVT

pelvic floor muscle and whole body vibration training once a week

Intervention Type: PROCEDURE

Other Intervention Names

brand name: vesicare; Pelvic Floor Muscle Training; Whole Body Vibration Training; Galileo

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Cantonal Hospital, Frauenfeld

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Volker Viereck

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Volker VV Viereck, physican

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital, Frauenfeld

Locations

Blasenzentrum, Cantonal Hospital

Frauenfeld, Thurgau, Switzerland

Countries

Switzerland

Other Identifiers

SOL-OAB-01-08

Identifier Type: -

Identifier Source: org_study_id