NCT00224146

Brief Summary

This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,878

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

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

May 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

September 14, 2005

Last Update Submit

November 29, 2011

Conditions

Overactive BladderUrinary IncontinenceQuality of Life

Keywords

Oxytrol(r)transdermal oxybutyninoveractive bladder

Outcome Measures

Primary Outcomes (1)

  • Change in health-related quality of life

Secondary Outcomes (5)

  • Change in other outcomes such as:

  • depression

  • work productivity

  • participant satisfaction

  • effect of enhanced patient education on any of the above outcomes

Interventions

oxybutynin transdermal delivery system (Oxytrol(r))DRUG

Eligibility Criteria

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

You may qualify if:

  • Adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency

You may not qualify if:

  • Patients for whom Oxytrol(r) is contraindicated.
  • Patients treated with Oxytrol(r) prior to participation in this study.
  • Patients residing in long-term care facilities or nursing homes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Mobile, Alabama, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Rocky Hill, Connecticut, United States

Location

Unknown Facility

Valdosta, Georgia, United States

Location

Unknown Facility

Gretna, Louisiana, United States

Location

Unknown Facility

Bloomfield Hills, Michigan, United States

Location

Unknown Facility

Poughkeepsie, New York, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Tomball, Texas, United States

Location

Related Publications (3)

  • Sand P, Zinner N, Newman D, Lucente V, Dmochowski R, Kelleher C, Dahl NV. Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community-based, randomized study. BJU Int. 2007 Apr;99(4):836-44. doi: 10.1111/j.1464-410X.2006.06658.x. Epub 2006 Dec 20.

    PMID: 17187655RESULT

  • Sand PK, Goldberg RP, Dmochowski RR, McIlwain M, Dahl NV. The impact of the overactive bladder syndrome on sexual function: a preliminary report from the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin trial. Am J Obstet Gynecol. 2006 Dec;195(6):1730-5. doi: 10.1016/j.ajog.2006.08.013.

    PMID: 17132474RESULT

  • Staskin DR, Rosenberg MT, Dahl NV, Polishuk PV, Zinner NR. Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions. Int J Clin Pract. 2008 Jan;62(1):27-38. doi: 10.1111/j.1742-1241.2007.01625.x. Epub 2007 Nov 15.

    PMID: 17983434RESULT

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

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

Study Officials

  • Naomi V. Dahl, PharmD

    Watson Laboratories, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

May 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

US(10)