A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Change from baseline in mean number of micturitions per 24 hours after 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean number of micturitions per 24 hours after 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean urgency frequency per 24 hours [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]
- Change from baseline in number of pads used [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]
- Incidence and severity of adverse events [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: Yes ]
| 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 aand 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Show 64 Study Locations| Principal Investigator: | Astellas Medical Affairs Europe | University Hospital, Lund, Sweden |
More Information
No publications provided
| Responsible Party: | Disclosure Office Europe, Astellas Pharma Europe BV |
| ClinicalTrials.gov Identifier: | NCT00337558 History of Changes |
| Other Study ID Numbers: | 905-EC-003 |
| Study First Received: | June 14, 2006 |
| Last Updated: | December 2, 2008 |
| Health Authority: | Italy: Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency Ireland: Irish Medicines Board Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Keywords provided by Astellas Pharma Inc:
|
treatment outcomes Overactive bladder Solifenacin succinate |
urinary incontinence urge incontinence frequency |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Urge Urinary Bladder, Overactive Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Urinary Bladder Diseases |
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013