PMID- 15570576
OWN - NLM
STAT- MEDLINE
DCOM- 20050210
LR  - 20151119
IS  - 0733-2467 (Print)
IS  - 0733-2467 (Linking)
VI  - 24
IP  - 1
DP  - 2005
TI  - "Unblinding" in randomized controlled drug trials for urinary incontinence: 
      Implications for assessing outcomes when adverse effects are evident.
PG  - 13-20
AB  - AIMS: To determine whether women with urinary incontinence (UI) can identify 
      their allocation in a randomized controlled trial (RCT) of tolterodine (TOL), and 
      whether correct identification is associated with outcomes and adverse effects 
      (AEs). METHODS: Exploratory analysis of a randomized, double-blind, placebo 
      (PLC)-controlled trial of TOL 4 mg daily for 8 weeks in 743 women with 
      urge-predominant mixed UI. Patient perception of their randomization was assessed 
      at trial end. Main outcome measures were 7-day bladder diaries, patient 
      perception of improvement, and UI-specific quality of life (QoL). RESULTS: TOL 
      produced a significant decrease in urge UI episodes compared to PLC (78% vs. 51%, 
      P = 0.0001). Fifty-one percent of women correctly identified their randomization 
      (58% on TOL vs. 37% on PLC, P < 0.001). Women who assumed they took TOL had 
      better bladder diary outcomes than those who assumed they took PLC. Within each 
      assumption group, patient perception outcomes were similar, regardless of actual 
      randomization. QoL improved in all domains except general health for women on 
      TOL. In women who assumed they took TOL, significant drug benefit was evident in 
      three domains. Moderate-severe dry mouth was higher in those who assumed they 
      took TOL (7.3% vs. 0%, P < 0.0001). CONCLUSIONS: Greater than fifty percent of 
      women in this RCT of antimuscarinic treatment were "unblinded" to their 
      randomization. Patient assumption of randomization was associated with bladder 
      diary and perception outcomes, specific QoL domains, and dry mouth. Efficacy of 
      urge incontinence drugs should be considered in the context of patient 
      assumptions, expectations, and "unblinding" by easily evident side effects.
FAU - DuBeau, Catherine E
AU  - DuBeau CE
AD  - Section of Geriatrics, University of Chicago, Chicago, Illinois 60637, USA. 
      cdubeau@medicine.bsd.uchicago.edu
FAU - Khullar, Vik
AU  - Khullar V
FAU - Versi, Eboo
AU  - Versi E
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Cresols)
RN  - 0 (Muscarinic Antagonists)
RN  - 33RU150WUN (Phenylpropanolamine)
RN  - 5T619TQR3R (Tolterodine Tartrate)
SB  - IM
CIN - J Urol. 2005 Aug;174(2):609-10. PMID: 16006917
MH  - Aged
MH  - Benzhydryl Compounds/*adverse effects
MH  - Cresols/*adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Medical Records
MH  - Middle Aged
MH  - Muscarinic Antagonists/*adverse effects
MH  - Patient Satisfaction
MH  - Phenylpropanolamine/*adverse effects
MH  - Tolterodine Tartrate
MH  - Treatment Outcome
MH  - Urinary Incontinence/*drug therapy/psychology
EDAT- 2004/12/01 09:00
MHDA- 2005/02/11 09:00
CRDT- 2004/12/01 09:00
PHST- 2004/12/01 09:00 [pubmed]
PHST- 2005/02/11 09:00 [medline]
PHST- 2004/12/01 09:00 [entrez]
AID - 10.1002/nau.20083 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2005;24(1):13-20. doi: 10.1002/nau.20083.