A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)

NCT00337558 | Completed Phase 4

• 1 other identifier: 905-EC-003
• Study Type: interventional
• Target: 643
• Locations: 11 countries
• Sites: 64

Brief 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.

Conditions

Overactive Bladder; Urinary Incontinence; Urge Incontinence

Keywords

treatment outcomes; Overactive bladder; Solifenacin succinate; urinary incontinence; urge incontinence; frequency

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean number of micturitions per 24 hours after 8 weeks

  8 weeks

Secondary Outcomes (5)

• Change from baseline in mean number of micturitions per 24 hours after 16 weeks

  16 weeks

• Change from baseline in mean urgency frequency per 24 hours

  8 and 16 weeks

• Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours

  8 and 16 weeks

• Change from baseline in number of pads used

  8 and 16 weeks

• Incidence and severity of adverse events

  8 and 16 weeks

Study Arms (2)

1

EXPERIMENTAL

Solifenacin succinate

Drug: Solifenacin succinate

2

EXPERIMENTAL

Solifenacin succinate and simplified bladder training

Behavioral: Simplified bladder training

Interventions

Solifenacin succinate DRUG

tablet

Also known as: YM905

1

Simplified bladder training BEHAVIORAL

Instructions

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for\> 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Europe B.V.: collaborator

Study Sites (64)

Unknown Facility

Kogarah, New South Wales, 2217, Australia

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Randwick, New South Wales, 2031, Australia

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Auchenflower, Queensland, 4066, Australia

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Clayton, Victoria, 3168, Australia

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Concord, Australia

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Parkville, Australia

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Antwerp, 2020, Belgium

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Brussels, 1090, Belgium

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Ghent, Belgium

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Kortrijk, 8500, Belgium

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La Louvière, Belgium

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Sint-Truiden, 3800, Belgium

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Jihlava, 586 01, Czechia

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Liberec, 460 63, Czechia

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Olomouc, 772 00, Czechia

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Pilsen, 326 00, Czechia

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Prague, 147 00, Czechia

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Annecy, France

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Arras, France

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Bordeaux, France

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Landerneau, France

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Marseille, France

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Paris, France

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Rouen, France

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Saint-Louis, France

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Thionville, France

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Toulouse, 31400, France

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Valenciennes, France

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Vernon, France

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Budapest, H-1145, Hungary

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Budapest, Hungary

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Kecskemét, Hungary

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Nyíregyháza, H-4400, Hungary

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Tatabánya, Hungary

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Bari, Italy

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Cinisello Balsamo, Italy

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Como, Italy

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Genova, Italy

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Milan, 20092, Italy

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Naples, Italy

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Leiden, 2334, Netherlands

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Roermond, 6043, Netherlands

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Tilburg, 5022, Netherlands

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Zwijndrecht, 331, Netherlands

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Warsaw, 00-846, Poland

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Warsaw, 02-520, Poland

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Moscow, 101000, Russia

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Moscow, 117815, Russia

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Moscow, 119049, Russia

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Moscow, 119415, Russia

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Moscow, 125206, Russia

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Saint Petersburg, 197098, Russia

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Avilés, Spain

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Burgos, Spain

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Madrid, Spain

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Manacor, Spain

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Marbella, Spain

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Santander, Spain

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Santiago de Compostela, Spain

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Seville, Spain

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 19818077 BACKGROUND

• Funada 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.

  PMID: 37811598 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Urinary Incontinence, Urge

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Astellas Medical Affairs Europe

  University Hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 16, 2006
• Study Start: May 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

RU (6); IT (6); BE (8); CZ (5); TU (2); FR (12); AU (6); PL (2); ES (8); HU (5); NL (4)