Clinical trial NCT01314781: Therapy of the Overactive Bladder Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Overactive Bladder
urinary frequency
Lead sponsor: Cantonal Hospital, Frauenfeld
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2011-03-15
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change of patient perception of bladder condition (PPBC)
timeFrame: baseline and 16 weeks
Secondary outcomes:
measure: Change in micturitions/24h based on a 3-day micturition diary
timeFrame: baseline and 16 weeks
measure: Change of urgency episodes (grade ≥3) /24h
timeFrame: baseline and 16 weeks
measure: Change in volume voided per micturition
timeFrame: baseline and 16 weeks
measure: Change in number of incontinence and urge incontinence episodes/24h
timeFrame: baseline and 16 weeks
measure: Change in number of pads used/24h
timeFrame: baseline and 16 weeks
Other outcomes:
Locations:
city: Frauenfeld
country: Switzerland
facility: Blasenzentrum, Cantonal Hospital
state: Thurgau
Study officials:
affiliation: Cantonal Hospital, Frauenfeld
name: Volker VV Viereck, physican
role: PRINCIPAL_INVESTIGATOR
References: