Overactive BladderPhase 4VECTORNCT00431041

Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

A Phase 4 study testing solifenacin and oxybutynin immediate release in people with Overactive Bladder, run by Astellas Pharma Inc at 12 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: solifenacin and oxybutynin immediate release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 12 sitesCanada
Study dates: Dec 2006to Feb 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults 18 years and older.
Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

Who cannot join

Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
Clinically significant outflow obstruction
Uncontrolled narrow angle glaucoma, urinary, or gastric retention
Severe renal or hepatic impairment
Chronic severe constipation or history of diagnosed GI obstructive disease
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
Diagnosis or history of neurogenic bladder
History of bladder or pelvic cancer

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Canada12 sites

Study site
Calgary, Alberta, T2V 4R6
Study site
Edmonton, Alberta, T5H 3V9
Study site
Guelph, Ontario, N1H 5J1
Study site
Halifax, Nova Scotia, B3H 3A7
Study site
Kitchener, Ontario, N2N 2B9
Study site
Montreal, Quebec, H3T 1E2
Study site
Toronto, Ontario, M4N 3M5
Study site
Toronto, Ontario, M5G 1Z5
Study site
Toronto, Ontario, M5T 2S8
Study site
Toronto, Ontario, M6A 3B5
Study site
Vancouver, British Columbia, V6T 2B5
Study site
Victoria, British Columbia, V8T 5G1

Other trials in Canada

About this study

Official title: VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Read the detailed description

This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Conditions: Overactive Bladder
Being tested: solifenacin, oxybutynin immediate release
Keywords: Solifenacin succinate, Oxybutynin immediate release, Xerostomia, Overactive bladder
Medical subject headings: Urinary Bladder, Overactive, Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

solifenacinDrug
Also called VESIcare®, YM905
Oral
oxybutynin immediate releaseDrug
Oral

Study groups in NCT00431041
Study group	Role	What they receive
Solifenacin	Experimental	Solifenacin succinate: 5 mg tablets, taken orally, once daily Receives: Drug: solifenacin
Oxybutynin IR	Active comparator	Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day Receives: Drug: oxybutynin immediate release

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
Measured: 8 weeks
The Severity of Dry Mouth Reported as an Adverse Event
The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).
Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) \& "severe" (very dry mouth \& throat, difficulty swallowing solid food without water)
Measured: 8 weeks

Secondary outcomes (2)

Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.
The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline.
Measured: Baseline and 8 Weeks
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.
The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline.
Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Feb 2008

First posted2 Feb 2007 (estimated)
Study startDec 2006
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Overactive BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00431041
Sponsor's protocol ID: VES-001
Acronym: VECTOR
Status last verified: Jun 2010
First submitted: 1 Feb 2007
Last updated: 8 Jun 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Herschorn S, Stothers L, Carlson K, Egerdie B, Gajewski JB, Pommerville P, Schulz J, Radomski S, Drutz H, Barkin J, Paradiso-Hardy F. Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: results of the VECTOR trial. J Urol. 2010 May;183(5):1892-8. doi: 10.1016/j.juro.2010.01.012. Epub 2010 Mar 29.
PubMed 20303119
Herschorn S, Pommerville P, Stothers L, Egerdie B, Gajewski J, Carlson K, Radomski S, Drutz H, Schulz J, Barkin J, Hirshberg E, Corcos J. Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (</= 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study. Curr Med Res Opin. 2011 Feb;27(2):375-82. doi: 10.1185/03007995.2010.541433. Epub 2010 Dec 23.
PubMed 21175373
Herschorn S, Vicente C, Piwko C. Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder. J Med Econ. 2010;13(3):508-15. doi: 10.3111/13696998.2010.509244.
PubMed 20690893

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients
ClinicalTrials.gov ID: NCT00431041
Acronym / sponsor ID: VECTOR / VES-001
Conditions: Overactive Bladder
Keywords: Solifenacin succinate, Oxybutynin immediate release, Xerostomia, Overactive bladder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Collaborators: Astellas Pharma Canada, Inc.
Study start: Dec 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 2 Feb 2007 (estimated)
Results: Posted 11 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Solifenacin	Experimental	Drug: solifenacinSolifenacin succinate: 5 mg tablets, taken orally, once daily
Oxybutynin IR	Active comparator	Drug: oxybutynin immediate releaseOxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adults 18 years and older.
Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

Key exclusion criteria (8 listed)

Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
Clinically significant outflow obstruction
Uncontrolled narrow angle glaucoma, urinary, or gastric retention
Severe renal or hepatic impairment
Chronic severe constipation or history of diagnosed GI obstructive disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
solifenacinAlso: VESIcare®, YM905Oral	Drug	Solifenacin
oxybutynin immediate releaseOral	Drug	Oxybutynin IR

Primary outcome

The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
Time frame: 8 weeks
The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
The Severity of Dry Mouth Reported as an Adverse Event
Time frame: 8 weeks
The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE). Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) \& "severe" (very dry mouth \& throat, difficulty swallowing solid food without water)

2 secondary outcomes

Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
Time frame: Baseline and 8 Weeks
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
Time frame: Baseline and 8 weeks

Results and safety

Results posted to the registry on 11 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solifenacin	68	52
Oxybutynin IR	64	40

Primary outcome: The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event

Time frame: 8 weeks. Number. Unit: participants

Measure	Solifenacin n = 68	Oxybutynin IR n = 64
Value	24	53

Solifenacin vs Oxybutynin IR: p <0.0001, Chi-squared

Population analysed: Data represents ITT Population: all randomized subjects

Primary outcome: The Severity of Dry Mouth Reported as an Adverse Event

Time frame: 8 weeks. Number. Unit: participants

Measure	Solifenacin n = 68	Oxybutynin IR n = 64
Mild	18	16
Moderate	3	22
Severe	3	15

Solifenacin vs Oxybutynin IR: p = 0.0010, Chi-squared

Population analysed: Data represents ITT Population: all randomized subjects

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solifenacin	3 of 68 (4.4%)	36 of 68 (52.9%)	Not reported
Oxybutynin IR	0 of 64 (0%)	56 of 64 (87.5%)	Not reported

Limitations and caveats (from the sponsor): The relatively high incidence of AEs, specifically dry mouth, in both groups may be a result of the direct questioning methodology used. Subjects were also informed the primary objectives were the relative frequency and severity of dry mouth.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20303119Herschorn S, Stothers L, Carlson K, Egerdie B, Gajewski JB, Pommerville P, Schulz J, Radomski S, Drutz H, Barkin J, Paradiso-Hardy F. Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: results of the VECTOR trial. J Urol. 2010 May;183(5):1892-8. doi: 10.1016/j.juro.2010.01.012. Epub 2010 Mar 29.
Derived from this study: PubMed 21175373Herschorn S, Pommerville P, Stothers L, Egerdie B, Gajewski J, Carlson K, Radomski S, Drutz H, Schulz J, Barkin J, Hirshberg E, Corcos J. Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (</= 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study. Curr Med Res Opin. 2011 Feb;27(2):375-82. doi: 10.1185/03007995.2010.541433. Epub 2010 Dec 23.
Derived from this study: PubMed 20690893Herschorn S, Vicente C, Piwko C. Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder. J Med Econ. 2010;13(3):508-15. doi: 10.3111/13696998.2010.509244.
Link to prescribing informationLink provided by the sponsor.

Related trials for Overactive Bladder

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Use Central Contact study director

Astellas Pharma Canada, Inc.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing solifenacin and oxybutynin immediate release in people with Overactive Bladder, run by Astellas Pharma Inc at 12 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00431041, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2010.