PMID- 18342185
OWN - NLM
STAT- MEDLINE
DCOM- 20080528
LR  - 20131121
IS  - 1527-9995 (Electronic)
IS  - 0090-4295 (Linking)
VI  - 71
IP  - 3
DP  - 2008 Mar
TI  - Trospium 60 mg once daily (QD) for overactive bladder syndrome: results from a 
      placebo-controlled interventional study.
PG  - 449-54
LID - 10.1016/j.urology.2007.11.008 [doi]
AB  - OBJECTIVES: A once-daily (QD) formulation of trospium chloride has been developed 
      for the management of overactive bladder syndrome (OAB). This randomized 
      controlled trial evaluated the efficacy and tolerability of this new 
      extended-release formulation, trospium chloride 60 mg QD. METHODS: Adults with 
      OAB with urinary urgency, frequency, and urgency urinary incontinence (UUI) were 
      eligible for inclusion. Subjects received trospium 60 mg QD or placebo for 12 
      weeks. Change in the mean number of toilet voids per day and UUI episodes per day 
      were the primary outcome variables. Changes in urgency severity were also 
      assessed and adverse events (AEs) were recorded. RESULTS: Overall, 564 subjects 
      participated in the study (trospium QD 280; placebo 284). Trospium QD 
      demonstrated significant improvement in both primary outcome variables. The mean 
      number of toilet voids per day was reduced from approximately 13 at baseline to 
      10.3 for trospium QD versus 11.1 for placebo (P <0.001) at week 12, whereas the 
      number of UUI episodes per day was reduced from approximately 4 at baseline to 
      1.7 at week 12 with trospium QD versus 2.4 for placebo (P <0.001). Trospium QD 
      also reduced urgency severity (P <0.001) and increased voided volume (P <0.01) 
      compared with placebo. Benefits over placebo were apparent within the first week 
      of treatment. Trospium QD was well tolerated; the most frequent AEs being dry 
      mouth (trospium QD 12.9%; placebo 4.6%) and constipation (7.5% versus 1.8%, 
      respectively). Central nervous system side effects were rarely observed and were 
      comparable between groups. CONCLUSIONS: Trospium QD represents a convenient, 
      effective, and well-tolerated treatment option for OAB.
FAU - Dmochowski, Roger R
AU  - Dmochowski RR
AD  - Department of Urology, Vanderbilt University School of Medicine, Nashville, 
      Tennessee 37232, USA. roger.dmochowski@vanderbilt.edu
FAU - Sand, Peter K
AU  - Sand PK
FAU - Zinner, Norman R
AU  - Zinner NR
FAU - Staskin, David R
AU  - Staskin DR
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Urology
JT  - Urology
JID - 0366151
RN  - 0 (Benzilates)
RN  - 0 (Nortropanes)
RN  - 1E6682427E (trospium chloride)
SB  - IM
MH  - Benzilates
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nortropanes/*administration & dosage
MH  - Prospective Studies
MH  - Urinary Bladder, Overactive/*drug therapy
EDAT- 2008/03/18 09:00
MHDA- 2008/05/29 09:00
CRDT- 2008/03/18 09:00
PHST- 2007/05/01 00:00 [received]
PHST- 2007/09/25 00:00 [revised]
PHST- 2007/11/02 00:00 [accepted]
PHST- 2008/03/18 09:00 [pubmed]
PHST- 2008/05/29 09:00 [medline]
PHST- 2008/03/18 09:00 [entrez]
AID - S0090-4295(07)02356-4 [pii]
AID - 10.1016/j.urology.2007.11.008 [doi]
PST - ppublish
SO  - Urology. 2008 Mar;71(3):449-54. doi: 10.1016/j.urology.2007.11.008.