Overactive BladderPhase 4SOLARNCT00337558
A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
A Phase 4 study testing Solifenacin succinate and Simplified bladder training in people with Overactive Bladder and Urinary Incontinence, run by Astellas Pharma Inc at 64 sites in 11 countries.
Trial summary
This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Urinary Incontinence, Urge Incontinence
- What is being tested?
- Solifenacin succinate and Simplified bladder training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 64 sitesin 11 countries
- Study dates
- May 2006to May 2007
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for> 3 months
Who cannot join
- Clinically significant outflow obstruction
- Significant post void residual volume
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
- Patient with a neurological cause for abnormal detrusor activity.
- Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Trial locations and contacts
64 sites in 11 countries.
64 sites in 11 countries
France12 sites
Study site
Annecy
Study site
Arras
Study site
Bordeaux
Study site
Landerneau
Study site
Marseille
Study site
Paris
Study site
Rouen
Study site
Saint-Louis
Study site
Thionville
Study site
Toulouse, 31400
Study site
Valenciennes
Study site
Vernon
Belgium8 sites
Study site
Antwerp, 2020
Study site
Brussels, 1090
Study site
Brussels, 1200
Study site
Ghent, 9000
Study site
Ghent
Study site
Kortrijk, 8500
Study site
La Louvière
Study site
Sint-Truiden, 3800
Spain8 sites
Study site
Avilés
Study site
Burgos
Study site
Madrid
Study site
Manacor
Study site
Marbella
Study site
Santander
Study site
Santiago de Compostela
Study site
Seville
Australia6 sites
Study site
Auchenflower, Queensland, 4066
Study site
Clayton, Victoria, 3168
Study site
Concord
Study site
Kogarah, New South Wales, 2217
Study site
Parkville
Study site
Randwick, New South Wales, 2031
Italy6 sites
Study site
Bari
Study site
Cinisello Balsamo
Study site
Como
Study site
Genova
Study site
Milan, 20092
Study site
Naples
Russia6 sites
Study site
Moscow, 101000
Study site
Moscow, 117815
Study site
Moscow, 119049
Study site
Moscow, 119415
Study site
Moscow, 125206
Study site
Saint Petersburg, 197098
Czechia5 sites
Study site
Jihlava, 586 01
Study site
Liberec, 460 63
Study site
Olomouc, 772 00
Study site
Pilsen, 326 00
Study site
Prague, 147 00
Hungary5 sites
Study site
Budapest, H-1145
Study site
Budapest
Study site
Kecskemét
Study site
Nyíregyháza, H-4400
Study site
Tatabánya
Netherlands4 sites
Study site
Leiden, 2334
Study site
Roermond, 6043
Study site
Tilburg, 5022
Study site
Zwijndrecht, 331
About this study
Official title: Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study
This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.
Read the detailed description
Subjects are screened between day -14 and day -1.
At day 0 subjects will enter a randomized, parallel group study. After fulfilling all selection criteria, subjects will be randomized to one of two treatment arms, solifenacin 5mg with bladder training or solifenacin 5mg alone. After 8 weeks of treatment subjects will be sub divided; subjects on solifenacin 5mg with bladder training will be given the option to increase dose and be divided into solifenacin 5mg with bladder training or solifenacin 10mg with bladder training. Subjects on solifenacin alone, will also be given the option to increase dose and be divided into solifenacin 5mg alone and solifenacin 10mg alone.
There are 5 visits in total: visit 1(screening), visit 2 (randomisation), visit 3 (week 4), visit 4 (week 8), telephone visit (week 12) and visit 5 (week 16)
All subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (Company code: YM905, Company serial number: RVG29151)
Subjects randomized to bladder training will receive a single sheet of instructions for bladder training.
- Conditions
- Overactive Bladder, Urinary Incontinence, Urge Incontinence
- Being tested
- Solifenacin succinate, Simplified bladder training
- Keywords
- treatment outcomes, Overactive bladder, Solifenacin succinate, urinary incontinence, urge incontinence, frequency
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin succinateDrug
Also called YM905
tablet
Simplified bladder trainingBehavioural
Instructions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Solifenacin succinate Receives: Drug: Solifenacin succinate |
| 2 | Experimental | Solifenacin succinate and simplified bladder training Receives: Behavioral: Simplified bladder training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean number of micturitions per 24 hours after 8 weeks
Measured: 8 weeks
Secondary outcomes (5)
Change from baseline in mean number of micturitions per 24 hours after 16 weeks
Measured: 16 weeks
Change from baseline in mean urgency frequency per 24 hours
Measured: 8 and 16 weeks
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Measured: 8 and 16 weeks
Change from baseline in number of pads used
Measured: 8 and 16 weeks
Incidence and severity of adverse events
Measured: 8 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 posted16 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Responsible party
- Sponsor
- Investigators
- Astellas Medical Affairs Europe, Principal investigator, University Hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337558
- Sponsor's protocol ID
- 905-EC-003
- Acronym
- SOLAR
- Status last verified
- Sep 2014
- First submitted
- 14 Jun 2006
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mattiasson A, Masala A, Morton R, Bolodeoku J; SOLAR Study Group. Efficacy of simplified bladder training in patients with overactive bladder receiving a solifenacin flexible-dose regimen: results from a randomized study. BJU Int. 2010 Apr;105(8):1126-35. doi: 10.1111/j.1464-410X.2009.08910.x. Epub 2009 Oct 10.
PubMed 19818077Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
PubMed 37811598
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study
- ClinicalTrials.gov ID
- NCT00337558
- Acronym / sponsor ID
- SOLAR / 905-EC-003
- Conditions
- Overactive Bladder, Urinary Incontinence, Urge Incontinence
- Keywords
- treatment outcomes, Overactive bladder, Solifenacin succinate, urinary incontinence, urge incontinence, frequency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V.
- Study start
- May 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 16 Jun 2006 (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.
This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.
Detailed description
Subjects are screened between day -14 and day -1.
At day 0 subjects will enter a randomized, parallel group study. After fulfilling all selection criteria, subjects will be randomized to one of two treatment arms, solifenacin 5mg with bladder training or solifenacin 5mg alone. After 8 weeks of treatment subjects will be sub divided; subjects on solifenacin 5mg with bladder training will be given the option to increase dose and be divided into solifenacin 5mg with bladder training or solifenacin 10mg with bladder training. Subjects on solifenacin alone, will also be given the option to increase dose and be divided into solifenacin 5mg alone and solifenacin 10mg alone.
There are 5 visits in total: visit 1(screening), visit 2 (randomisation), visit 3 (week 4), visit 4 (week 8), telephone visit (week 12) and visit 5 (week 16)
All subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (Company code: YM905, Company serial number: RVG29151)
Subjects randomized to bladder training will receive a single sheet of instructions for bladder training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Solifenacin succinateSolifenacin succinate |
| 2 | Experimental | Behavioral: Simplified bladder trainingSolifenacin succinate and simplified bladder training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for> 3 months
Key exclusion criteria (5 listed)
- Clinically significant outflow obstruction
- Significant post void residual volume
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
- Patient with a neurological cause for abnormal detrusor activity.
- Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
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 |
|---|---|---|
| Solifenacin succinateAlso: YM905tablet | Drug | 1 |
| Simplified bladder trainingInstructions | Behavioural | 2 |
Primary outcome
Change from baseline in mean number of micturitions per 24 hours after 8 weeks
Time frame: 8 weeks
5 secondary outcomes
Change from baseline in mean number of micturitions per 24 hours after 16 weeks
Time frame: 16 weeks
Change from baseline in mean urgency frequency per 24 hours
Time frame: 8 and 16 weeks
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Time frame: 8 and 16 weeks
Change from baseline in number of pads used
Time frame: 8 and 16 weeks
Incidence and severity of adverse events
Time frame: 8 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 18 Sep 2014.
- Background: PubMed 19818077Mattiasson A, Masala A, Morton R, Bolodeoku J; SOLAR Study Group. Efficacy of simplified bladder training in patients with overactive bladder receiving a solifenacin flexible-dose regimen: results from a randomized study. BJU Int. 2010 Apr;105(8):1126-35. doi: 10.1111/j.1464-410X.2009.08910.x. Epub 2009 Oct 10.
- Derived from this study: PubMed 37811598Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
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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.
Astellas Medical Affairs Europe principal investigator
University Hospital, Lund, Sweden
64 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin succinate and Simplified bladder training in people with Overactive Bladder and Urinary Incontinence, run by Astellas Pharma Inc at 64 sites in 11 countries.
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 1 inclusion and 5 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in France, Belgium, Spain, Australia, Italy and 6 more countries. 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 from baseline in mean number of micturitions per 24 hours after 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00337558, which also lists 2 linked publications.
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 18 Sep 2014.