Overactive BladderPhase 4TOBSNCT01314781
Therapy of the Overactive Bladder Syndrome
A Phase 4 study testing solifenacin and PFMT and WBVT in people with Overactive Bladder, run by Cantonal Hospital, Frauenfeld at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- solifenacin and PFMT and WBVT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Blasenzentrum, Cantonal Hospital
Frauenfeld, Thurgau, 8501
About this study
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
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.
Read the 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
- Being tested
- solifenacin, PFMT and WBVT
- Keywords
- Overactive Bladder, urinary frequency
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacinDrug
Also called brand name: vesicare
solifenacin 5mg tablet once daily
PFMT and WBVTProcedure or surgery
Also called Pelvic Floor Muscle Training, Whole Body Vibration Training, Galileo
pelvic floor muscle and whole body vibration training once a week
| Study group | Role | What they receive |
|---|---|---|
| solifenacin 5mg, PFMT and WBVT | Experimental | Patients randomized to group A will receive solifenacin 5mg tablet once daily and a training programme for PFMT and WBVT once a week. Receives: Drug: solifenacin; Procedure: PFMT and WBVT |
| solifenacin 5mg | Active comparator | Subjects randomised to group B will receive solifenacin 5mg tablet once daily. Receives: Drug: solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 16 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Frauenfeld
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
- Investigators
- Volker VV Viereck, physican, Principal investigator, Cantonal Hospital, Frauenfeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314781
- Sponsor's protocol ID
- SOL-OAB-01-08
- Acronym
- TOBS
- Status last verified
- May 2016
- First submitted
- 21 Jan 2011
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01314781
- Acronym / sponsor ID
- TOBS / SOL-OAB-01-08
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, urinary frequency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cantonal Hospital, FrauenfeldUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solifenacin 5mg, PFMT and WBVT | Experimental | Drug: solifenacin, Procedure: PFMT and WBVTPatients randomized to group A will receive solifenacin 5mg tablet once daily and a training programme for PFMT and WBVT once a week. |
| solifenacin 5mg | Active comparator | Drug: solifenacinSubjects randomised to group B will receive solifenacin 5mg tablet once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solifenacinAlso: brand name: vesicaresolifenacin 5mg tablet once daily | Drug | solifenacin 5mg, solifenacin 5mg, PFMT and WBVT |
| PFMT and WBVTAlso: Pelvic Floor Muscle Training, Whole Body Vibration Training, Galileopelvic floor muscle and whole body vibration training once a week | Procedure or surgery | solifenacin 5mg, PFMT and WBVT |
Primary outcome
Change of patient perception of bladder condition (PPBC)
Time frame: baseline and 16 weeks
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.
5 secondary outcomes
Change in micturitions/24h based on a 3-day micturition diary
Time frame: baseline and 16 weeks
Change of urgency episodes (grade ≥3) /24h
Time frame: baseline and 16 weeks
Change in volume voided per micturition
Time frame: baseline and 16 weeks
Change in number of incontinence and urge incontinence episodes/24h
Time frame: baseline and 16 weeks
Change in number of pads used/24h
Time frame: baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker VV Viereck, physican principal investigator
Cantonal Hospital, Frauenfeld
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing solifenacin and PFMT and WBVT in people with Overactive Bladder, run by Cantonal Hospital, Frauenfeld at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of patient perception of bladder condition (PPBC) (time frame: baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.