Therapy of the Overactive Bladder Syndrome (TOBS)

This study is currently recruiting participants.
Verified August 2013 by Cantonal Hospital, Frauenfeld
Sponsor:
Collaborator:
Astellas Pharma AG, Switzerland
Information provided by (Responsible Party):
Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier:
NCT01314781
First received: January 21, 2011
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: solifenacin
Procedure: PFMT and WBVT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital, Frauenfeld:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 66
Study Start Date: January 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: brand name: vesicare
Procedure: PFMT and WBVT
pelvic floor muscle and whole body vibration training once a week
Other Names:
  • Pelvic Floor Muscle Training
  • Whole Body Vibration Training
  • Galileo
Active Comparator: solifenacin 5mg
Subjects randomised to group B will receive solifenacin 5mg tablet once daily.
Drug: solifenacin
solifenacin 5mg tablet once daily
Other Name: brand name: vesicare

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314781

Contacts
Contact: Volker VV Viereck, physican ++41 52 723 70 50 volker.viereck@stgag.ch
Contact: Oliver OR Rautenberg, physican ++41 52 723 77 45 olliver.rautenberg@stgag.ch

Locations
Switzerland
Blasenzentrum, Cantonal Hospital Recruiting
Frauenfeld, Thurgau, Switzerland, 8501
Contact: Volker VV Viereck, Physican    ++41 52 723 70 50    volker.viereck@stgag.ch   
Contact: Oliver OR Rautenberge, Physican    ++41 52 723 76 45    oliver.rautenberg@stgag.ch   
Principal Investigator: Volker VV Viereck, Physican         
Sub-Investigator: Oliver OR Rautenberg, Physican         
Sponsors and Collaborators
Cantonal Hospital, Frauenfeld
Astellas Pharma AG, Switzerland
Investigators
Principal Investigator: Volker VV Viereck, physican Cantonal Hospital, Frauenfeld
  More Information

No publications provided

Responsible Party: Prof. Dr. Volker Viereck, Prof. Dr., Cantonal Hospital, Frauenfeld
ClinicalTrials.gov Identifier: NCT01314781     History of Changes
Other Study ID Numbers: SOL-OAB-01-08
Study First Received: January 21, 2011
Last Updated: August 9, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Cantonal Hospital, Frauenfeld:
Overactive Bladder
urinary frequency

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014