We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337558
First Posted: June 16, 2006
Last Update Posted: September 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
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.

Condition Intervention Phase
Overactive Bladder Urinary Incontinence Urge Incontinence Drug: Solifenacin succinate Behavioral: Simplified bladder training Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in mean number of micturitions per 24 hours after 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 643
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Solifenacin succinate
Drug: Solifenacin succinate
tablet
Other Name: YM905
Experimental: 2
Solifenacin succinate and simplified bladder training
Behavioral: Simplified bladder training
Instructions

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337558


  Show 64 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Investigators
Principal Investigator: Astellas Medical Affairs Europe University Hospital, Lund, Sweden
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00337558     History of Changes
Other Study ID Numbers: 905-EC-003
First Submitted: June 14, 2006
First Posted: June 16, 2006
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc:
treatment outcomes
Overactive bladder
Solifenacin succinate
urinary incontinence
urge incontinence
frequency

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents