Relationship Between Subjective And Objective Assessments Of Sacral Neuromodulation Effectiveness In Patients With Urgency-Frequency

Main Category: Urology / Nephrology
Article Date: 19 Jan 2009 - 3:00 PDT

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UroToday.com - Global response assessments (GRAs) are patient self-reports that have been used as primary outcome measurements in clinical trials (1-5) including the pivotal sodium pentosanpolysulfate trials for FDA approval (6;7). They are subjective responses to assess overall treatment effectiveness and are particularly useful in conditions where symptom management is the treatment outcome. Peters and colleagues from Royal Oak, Michigan studied the relationship between subjective and objective assessments of sacral neuromodulation effectiveness in patients with urgency-frequency and specifically looked at the responsiveness of the GRA to changes in pelvic pain or urinary urgency and frequency after sacral nerve stimulation (SNS).

While GRA is generally used as a global assessment, incorporating numerous possible symptoms that generally categorize a condition, in this study participants were asked to rate their perception of change for urgency, frequency, and pelvic pain individually, and the results were compared to voiding diaries and mean urgency and pain recorded on 10 point scales before and at 3 and 6 months post initiation of SNS. Fifty patients with urgency-frequency with or without pelvic pain were selected for participation. Three months after implant, changes in mean voiding diary scores for frequency, urgency, and pelvic pain were congruent with responses on the GRA in both responders and non-responders. This also held true at 6 months, with the exception of pain in the responder group. Non-responders voiding diary data supported their GRA response for all symptoms at both follow-up times.

For potential therapies for multi-symptom syndromes, a GRA indicating overall improvement or quality of life may better capture drug-effect than individual objective measures of improvement, particularly if different individuals have differing responses to individual parts of the symptom complex, yielding no statistically significant specific symptom improvement despite an overall improvement in the study population. The authors comment that GRA is a simple, easy to use tool that takes into account variations in the particular patient's condition that are not reflected in just collecting quantitative data.

This is an important concept, originally introduced by Lowell Parsons in the Elmiron® trials, and seems to have proven valid over the years. It has been a major contribution to the field of BPS clinical research.

Peters KM, Killinger KA, Ibrahim IA, Villalba PS
Neurourol Urodyn. 2008;27(8):775-8.
doi:10.1002/nau.20592

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Written by UroToday.com Contributing Editor Philip M. Hanno, MD, MPH

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