PMID- 16151816
OWN - NLM
STAT- MEDLINE
DCOM- 20060209
LR  - 20220321
IS  - 0724-4983 (Print)
IS  - 0724-4983 (Linking)
VI  - 23
IP  - 4
DP  - 2005 Sep
TI  - Transdermal oxybutynin in the treatment of adults with overactive bladder: 
      combined results of two randomized clinical trials.
PG  - 263-70
AB  - The safety and efficacy of oxybutynin transdermal delivery system 
      (oxybutynin-TDS) versus placebo in adults with urge and mixed urinary 
      incontinence was investigated using combined results from double-blind stages of 
      2 phase 3 clinical trials. Study 1: placebo-controlled, parallel-group comparison 
      of 3 oxybutynin-TDS doses in 12-week double-blind and open-label periods, 
      followed by a 28-week open-label extension. Study 2 was a 12-week randomized, 
      double-blind, placebo-controlled comparison of oxybutynin-TDS versus long-acting 
      tolterodine and placebo, followed by a 52-week open-label extension. Efficacy 
      analysis included 241 patients receiving oxybutynin-TDS, 244 receiving placebo. 
      Most participants were Caucasian women (92%). Approximately 60% received prior 
      anticholinergic therapy. Primary outcome was determined by changes from baseline 
      to end of treatment in frequency of incontinence episodes, frequency of 
      urination, and void volume. Oxybutynin-TDS was significantly more effective than 
      placebo in reducing median daily incontinence episodes (-3.0 vs placebo -2.0; 
      P=.00004) and daily urinary frequency (-2.0 vs -1.0; P=.0023), and in increasing 
      void volume (25 mL vs 5.5 mL; P<.00001). Overall rates of anticholinergic adverse 
      events (AEs) were 12.8% for oxybutynin-TDS and 11.0% for placebo (P=0.5421). The 
      most common systemic anticholinergic AEs were dry mouth (7.0% for oxybutynin-TDS 
      vs 5.3% for placebo) and constipation (2.1% vs 2.0%). Application site erythema 
      occurred in 7.0% of participants who received oxybutynin-TDS (3.7% 
      discontinuation rate); pruritus occurred in 16.1% (3.3% discontinuation rate). 
      Transdermal oxybutynin was shown to be efficacious, with a proven safety profile. 
      It may be utilized for patients with overactive bladder as a treatment option 
      that could enhance compliance.
FAU - Dmochowski, Roger R
AU  - Dmochowski RR
AD  - Department of Urologic Surgery, Vanderbilt University, Nashville, TN 37235, USA. 
      roger.dmochowski@vanderbilt.edu
FAU - Nitti, Victor
AU  - Nitti V
FAU - Staskin, David
AU  - Staskin D
FAU - Luber, Karl
AU  - Luber K
FAU - Appell, Rodney
AU  - Appell R
FAU - Davila, G Willy
AU  - Davila GW
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20051108
PL  - Germany
TA  - World J Urol
JT  - World journal of urology
JID - 8307716
RN  - 0 (Mandelic Acids)
RN  - K9P6MC7092 (oxybutynin)
SB  - IM
MH  - Administration, Cutaneous
MH  - Aged
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Mandelic Acids/*administration & dosage
MH  - Middle Aged
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
MH  - Urinary Incontinence/*drug therapy/physiopathology/psychology
MH  - Urodynamics/drug effects
EDAT- 2005/09/10 09:00
MHDA- 2006/02/10 09:00
CRDT- 2005/09/10 09:00
PHST- 2005/01/10 00:00 [received]
PHST- 2005/05/16 00:00 [accepted]
PHST- 2005/09/10 09:00 [pubmed]
PHST- 2006/02/10 09:00 [medline]
PHST- 2005/09/10 09:00 [entrez]
AID - 10.1007/s00345-005-0012-8 [doi]
PST - ppublish
SO  - World J Urol. 2005 Sep;23(4):263-70. doi: 10.1007/s00345-005-0012-8. Epub 2005 
      Nov 8.