Abstract
Objective
To determine whether electronic bladder diaries are associated with a larger placebo
effect than paper diaries in studies of overactive bladder (OAB). To identify any
other factors in study design that may influence the placebo effect.
Study design
This is a secondary analysis of a previous systematic review and network meta-analysis
on the efficacy and tolerability of mirabegron. Each study was analysed and placebo
response rate (PRR) was calculated. Statistical analysis was used to look for associations
with different factors and PRR.
Results
The PRR was considerable in the studies analysed (10.5 % when calculated for change
in number of micturitions over 24 h and 41.2 % for change in urgency urinary incontinence
episodes over 24 h). Paper bladder diaries were associated with a significantly larger
placebo response rate than electronic (10.76 % vs 10.22 %), although this may be clinically
small. The size of study had a moderate positive correlation with PRR. Length of bladder
diary was not associated with increased PRR.
Conclusions
The PRR in studies of OAB is varied and significant. It is clear that it can be affected
by factors in study design including type of bladder diary. When designing clinical
studies this should be borne in mind. Equally, when attempting to optimise patient
care, the benefit of the therapeutic encounter should be remembered.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to European Journal of Obstetrics and Gynecology and Reproductive BiologyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- The powerful placebo.J Am Med Assoc. 1955; 159: 1602-1606
- Placebo interventions for all clinical conditions.Cochrane Database Syst Rev. 2010; : CD003974
- How much of the placebo’ effect’ is really statistical regression?.Stat Med. 1983; 2: 417-427
- Placebo effects in medicine.N Engl J Med. 2015; 373: 8-9
- An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP).Int Urogynecol J. 2016; 27: 655-684
- Outcome measures for stress urinary incontinence treatment: can we minimally agree?.World J Urol. 2015; 33: 1221-1234
- Evaluation and outcome measures in the treatment of female urinary stress incontinence: International Urogynecological Association (IUGA) guidelines for research and clinical practice.Int Urogynecol J Pelvic Floor Dysfunct. 2008; 19: 5-33
- Developing and validating the International Consultation on Incontinence Questionnaire bladder diary.Eur Urol. 2014; 66: 294-300
- Electronic bladder diaries of differing duration versus a paper diary for data collection in overactive bladder.Neurourol Urodyn. 2016; 35: 743-749
- Is the treatment of urgency incontinence a placebo response? Results of a five-year follow-up.Br J Urol. 1989; 64: 478-480
- Efficacy and tolerability of mirabegron compared with antimuscarinic monotherapy or combination therapies for overactive bladder: a systematic review and network meta-analysis.Eur Urol. 2018; 74: 324-333
- Computerized voiding diary.Neurourol Urodyn. 1993; 12 (discussion 53-4): 541-553
- Anticholinergic drugs versus placebo for overactive bladder syndrome in adults.Cochrane Database Syst Rev. 2006; : CD003781
- Reproducibility of the seven-day voiding diary in women with stress urinary incontinence.Int Urogynecol J Pelvic Floor Dysfunct. 2000; 11: 15-17
- A meta-analysis of the placebo response in antimuscarinic drug trials for overactive bladder.BMC Med Res Methodol. 2009; 9: 55
Article info
Publication history
Published online: January 22, 2020
Accepted:
January 20,
2020
Received in revised form:
January 13,
2020
Received:
November 14,
2019
Identification
Copyright
© 2020 Elsevier B.V. All rights reserved.
