Patient-reported outcomes in overactive bladder: Importance for determining clinical effectiveness of treatment
Section snippets
Patient-reported outcomes in overactive bladder
OAB is a chronic condition comprising several symptoms, the principal symptom being urgency,8 an abnormal, compelling desire to urinate in which patients may feel that leakage of urine is imminent; urgency may or may not result in urgency urinary incontinence (UUI).9 OAB is not life threatening and its symptoms typically do not cause overwhelming disability, yet OAB symptoms do greatly affect a patient’s life. Patients may lose sleep because of nocturia, curtail activities, limit travel, and
Incorporating patient-reported outcomes into overactive bladder clinical trials
The importance of PROs in assessing OAB symptom bother, HRQL, and patient satisfaction with treatment makes these measures an essential part of assessing efficacy in OAB clinical trials. Several reviews provide detailed discussion on issues to be considered when incorporating PROs into clinical trial protocols.1, 5, 27, 34, 35, 36 Overall, PROs, whether primary or secondary end points, must meet the same standards as those used for traditional clinical end points.27, 34, 35 Some basic
Conclusion
OAB is a symptom-defined condition, making it important to understand the patient’s perspective in assessing treatment effects. Patient reports of changes in OAB symptoms provide a better indication of treatment efficacy than do objective urodynamic tests, and they are the only means of determining the impact of treatment on HRQL. PRO data complement clinical outcomes in a research setting and allow investigators to determine whether any treatment-related improvement actually made a difference
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Cited by (0)
- 1
Linda Brubaker receives research funding from Q-Med, Pfizer Inc, and Allergan and receives consultant/speaker honoraria from Q-Med, Novartis, Pfizer Inc, and Astellas.
- 2
Christopher Chapple is a scientific consultant to Pfizer Inc, Astellas, Novartis, Schwarz, Q-Med, Tanabe, and Allergan; and receives funding from Pfizer, and Allergan.
- 3
Karin S. Coyne is a consultant to Pfizer Inc.
- 4
Zoe Kopp is an employee of Pfizer Inc.