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

Urinary Incontinence Clinical Trial

— SOLAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337558
• Other study ID #: 905-EC-003
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2006
• Last updated: September 17, 2014
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIreland: Irish Medicines BoardBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Drug:
• Solifenacin succinate
tablet

Behavioral:
• Simplified bladder training
Instructions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Australia,  Belgium,  Czech Republic,  France,  Hungary,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean number of micturitions per 24 hours after 8 weeks		8 weeks	No
Secondary	Change from baseline in mean number of micturitions per 24 hours after 16 weeks		16 weeks	No
Secondary	Change from baseline in mean urgency frequency per 24 hours		8 and 16 weeks	No
Secondary	Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours		8 and 16 weeks	No
Secondary	Change from baseline in number of pads used		8 and 16 weeks	No
Secondary	Incidence and severity of adverse events		8 and 16 weeks	Yes

External Links

•   Link to Results on JAPIC - enter 140586 in the JapicCTI-RNo. field