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.
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.
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.
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.
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 access
One-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 Biology
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- 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
Published online: January 22, 2020
Accepted: January 20, 2020
Received in revised form: January 13, 2020
Received: November 14, 2019
© 2020 Elsevier B.V. All rights reserved.