This study assessed the effect of different InterStim rate settings on voiding diary outcomes. Specifically, the study evaluated how 3 different rate settings affected the number of urinary incontinent episodes per day collected through a voiding diary. The study also evaluated how the 3 different rate settings affected other voiding diary measures including number of voids per day, degree of urgency before each void, number of pads used per day, and number of fecal incontinent episodes, questionnaires, and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
13
All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.
Kenneth Peters, MD
Royal Oak, Michigan, United States
Number of Urinary Incontinent Episodes Per Day
In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.
Time frame: three weeks
Number of Voids Per Day
In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.
Time frame: three weeks
Number of Pads Per Day
In a diary, subjects are asked to provide number of pads they used per day.
Time frame: three weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.