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

Primary Purpose

Overactive Bladder, Urinary Incontinence, Urge Incontinence

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Solifenacin succinate
Simplified bladder training
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring treatment outcomes, Overactive bladder, Solifenacin succinate, urinary incontinence, urge incontinence, frequency

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Solifenacin succinate

Solifenacin succinate and simplified bladder training

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in mean number of micturitions per 24 hours after 16 weeks
Change from baseline in mean urgency frequency per 24 hours
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Change from baseline in number of pads used
Incidence and severity of adverse events

Full Information

First Posted
June 14, 2006
Last Updated
September 17, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00337558
Brief Title
A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Incontinence, Urge Incontinence
Keywords
treatment outcomes, Overactive bladder, Solifenacin succinate, urinary incontinence, urge incontinence, frequency

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Solifenacin succinate
Arm Title
2
Arm Type
Experimental
Arm Description
Solifenacin succinate and simplified bladder training
Intervention Type
Drug
Intervention Name(s)
Solifenacin succinate
Other Intervention Name(s)
YM905
Intervention Description
tablet
Intervention Type
Behavioral
Intervention Name(s)
Simplified bladder training
Intervention Description
Instructions
Primary Outcome Measure Information:
Title
Change from baseline in mean number of micturitions per 24 hours after 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in mean number of micturitions per 24 hours after 16 weeks
Time Frame
16 weeks
Title
Change from baseline in mean urgency frequency per 24 hours
Time Frame
8 and 16 weeks
Title
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Time Frame
8 and 16 weeks
Title
Change from baseline in number of pads used
Time Frame
8 and 16 weeks
Title
Incidence and severity of adverse events
Time Frame
8 and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astellas Medical Affairs Europe
Organizational Affiliation
University Hospital, Lund, Sweden
Official's Role
Principal Investigator
Facility Information:
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Concord
Country
Australia
City
Parkville
Country
Australia
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Gent
Country
Belgium
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
La Louviere
Country
Belgium
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
City
Jihlava
ZIP/Postal Code
586 01
Country
Czech Republic
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
772 00
Country
Czech Republic
City
Plzen
ZIP/Postal Code
326 00
Country
Czech Republic
City
Prague
ZIP/Postal Code
147 00
Country
Czech Republic
City
Annecy Cedex
Country
France
City
Arras
Country
France
City
Bordeaux
Country
France
City
Landerneau
Country
France
City
Marseille
Country
France
City
Paris
Country
France
City
Rouen
Country
France
City
Saint Louis Cedex
Country
France
City
Thionville
Country
France
City
Toulouse
ZIP/Postal Code
31400
Country
France
City
Valenciennes
Country
France
City
Vernon
Country
France
City
Budapest
ZIP/Postal Code
H-1145
Country
Hungary
City
Budapest
Country
Hungary
City
Kecskemet
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
H-4400
Country
Hungary
City
Tatabanya
Country
Hungary
City
Bari
Country
Italy
City
Cinisello Balsamo
Country
Italy
City
Como
Country
Italy
City
Genova
Country
Italy
City
Milan
ZIP/Postal Code
20092
Country
Italy
City
Naples
Country
Italy
City
Leiden
ZIP/Postal Code
2334
Country
Netherlands
City
Roermond
ZIP/Postal Code
6043
Country
Netherlands
City
Tilburg
ZIP/Postal Code
5022
Country
Netherlands
City
Zwijndrecht
ZIP/Postal Code
331
Country
Netherlands
City
Warsaw
ZIP/Postal Code
00-846
Country
Poland
City
Warsaw
ZIP/Postal Code
02-520
Country
Poland
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117815
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119415
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125206
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197098
Country
Russian Federation
City
Aviles
Country
Spain
City
Burgos
Country
Spain
City
Madrid
Country
Spain
City
Manacor
Country
Spain
City
Marbella
Country
Spain
City
Santander
Country
Spain
City
Santiago de Compostela
Country
Spain
City
Sevilla
Country
Spain
City
Ankara
Country
Turkey
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19818077
Citation
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.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140586 in the JapicCTI-RNo. field

Learn more about this trial

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

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