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CompletedNCT00224146MATRIXUpdated Nov 30, 2011

Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder

A Phase 4 interventional study of oxybutynin transdermal delivery system (Oxytrol(r)) in Overactive Bladder, Urinary Incontinence and Quality of Life, sponsored by Watson Pharmaceuticals. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-30.

Sponsored by Watson Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
2,878
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Overactive Bladder
  • Urinary Incontinence
  • Quality of Life

Keywords

  • Oxytrol(r)
  • transdermal oxybutynin
  • overactive bladder
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 2,878 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Watson Pharmaceuticals is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,878 participants (actual)

Interventions

  • Drugoxybutynin transdermal delivery system (Oxytrol(r))
06

What researchers measure

Primary outcomes

  1. Change in health-related quality of life

Secondary outcomes

  1. Change in other outcomes such as:

  2. depression

  3. work productivity

  4. participant satisfaction

  5. effect of enhanced patient education on any of the above outcomes

07

Study locations

10 sites
  • Mobile, Alabama, United States
  • Tucson, Arizona, United States
  • Torrance, California, United States
  • Rocky Hill, Connecticut, United States
  • Valdosta, Georgia, United States
  • Gretna, Louisiana, United States
  • Bloomfield Hills, Michigan, United States
  • Poughkeepsie, New York, United States
  • Winston-Salem, North Carolina, United States
  • Tomball, Texas, United States
08

References and documents

Publications

  • 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. PubMed 17187655 ↗
  • 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. PubMed 17132474 ↗
  • 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. PubMed 17983434 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00224146
Lead sponsor
Watson Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
May 2004
Primary completion
May 2005
Completion
May 2005
Last update
Nov 30, 2011

Study contacts

Naomi V. Dahl, PharmD
study director · Watson Laboratories, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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