NCT00821184

Brief Summary

This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 30, 2010

Completed
Last Updated

April 4, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

January 9, 2009

Results QC Date

December 4, 2009

Last Update Submit

March 8, 2018

Conditions

Overactive Bladder

Keywords

urinary incontinenceoveractive bladderurinary frequency

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.

    0 week - 12 weeks

Secondary Outcomes (1)

  • Improvement of Symptom Severity

    3 months

Study Arms (2)

Vesicare

ACTIVE COMPARATOR

Vesicare alone

Drug: Vesicare (solifenacin)

Vesicare/behavioral modification

ACTIVE COMPARATOR

Vesicare plus behavioral modification

Behavioral: Vesicare (solifenacin) plus behavioral modification

Interventions

Vesicare (solifenacin)DRUG

5mg po qd

Vesicare
Vesicare (solifenacin) plus behavioral modificationBEHAVIORAL

5 mg dose po once daily plus behavioral modification

Also known as: Vesicare (solifenacin)
Vesicare/behavioral modification

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients \> 18 years of age
  • OAB symptoms for \> 3 months
  • Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.
  • May or may not be accompanied by urinary frequency
  • May be accompanied by stress urinary incontinence where stress incontinence does not predominate

You may not qualify if:

  • Male Patients
  • Underlying cortical or spinal cord pathology including SCI, MS, or
  • Parkinson's Disease
  • Urinary retention with post-void residual \> 150cc
  • Current treatment or treatment within the last 3 months with anticholinergic medications
  • Patients not able to complete the questionaires or voiding diaries in English
  • Pregnancy
  • Active urinary tract infections
  • Bladder Cancer or unevaluated hematuria
  • Known diagnosis of narrow angle glaucoma
  • Severe constipation
  • History of reduced renal function (CrCl\<30ml/min)
  • History of liver disease
  • Current treatment with cytochrome P450 inhibitor medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
John T. Stoffel, MD
Organization
Lahey Clinic
John.T.Stoffel@lahey.org
781-744-5481

Study Officials

  • John T Stoffel, M.D.

    Lahey Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 13, 2009

Study Start

September 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 4, 2018

Results First Posted

July 30, 2010

Record last verified: 2018-03

Locations

US(1)