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Therapy of the Overactive Bladder Syndrome (TOBS)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
solifenacin
PFMT and WBVT
Sponsored by
Cantonal Hospital, Frauenfeld
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, urinary frequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Blasenzentrum, Cantonal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

solifenacin 5mg, PFMT and WBVT

solifenacin 5mg

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 21, 2011
Last Updated
May 19, 2016
Sponsor
Cantonal Hospital, Frauenfeld
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01314781
Brief Title
Therapy of the Overactive Bladder Syndrome
Acronym
TOBS
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital, Frauenfeld
Collaborators
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, urinary frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
solifenacin 5mg, PFMT and WBVT
Arm Type
Experimental
Arm Description
Patients randomized to group A will receive solifenacin 5mg tablet once daily and a training programme for PFMT and WBVT once a week.
Arm Title
solifenacin 5mg
Arm Type
Active Comparator
Arm Description
Subjects randomised to group B will receive solifenacin 5mg tablet once daily.
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
brand name: vesicare
Intervention Description
solifenacin 5mg tablet once daily
Intervention Type
Procedure
Intervention Name(s)
PFMT and WBVT
Other Intervention Name(s)
Pelvic Floor Muscle Training, Whole Body Vibration Training, Galileo
Intervention Description
pelvic floor muscle and whole body vibration training once a week
Primary Outcome Measure Information:
Title
Change of patient perception of bladder condition (PPBC)
Description
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.
Time Frame
baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Change in micturitions/24h based on a 3-day micturition diary
Description
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.
Time Frame
baseline and 16 weeks
Title
Change of urgency episodes (grade ≥3) /24h
Description
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.
Time Frame
baseline and 16 weeks
Title
Change in volume voided per micturition
Description
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.
Time Frame
baseline and 16 weeks
Title
Change in number of incontinence and urge incontinence episodes/24h
Description
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.
Time Frame
baseline and 16 weeks
Title
Change in number of pads used/24h
Description
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.
Time Frame
baseline and 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker VV Viereck, physican
Organizational Affiliation
Cantonal Hospital, Frauenfeld
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blasenzentrum, Cantonal Hospital
City
Frauenfeld
State/Province
Thurgau
ZIP/Postal Code
8501
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapy of the Overactive Bladder Syndrome

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