The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.
This feasibility study will assess the following outcomes: * Voiding diaries * Patient reported assessments of response or satisfaction * Adverse events
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Pinellas Urology, Inc.
St. Petersburg, Florida, United States
University of Iowa Healthcare
Iowa City, Iowa, United States
Metro Urology
Woodbury, Minnesota, United States
Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion
Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.
Time frame: 4 weeks
Degree of Urgency - Randomized Portion
Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.
Time frame: 4 week
Number of Pads Used Per Day - Randomized Portion
Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.
Time frame: 4 weeks
Global Response Assessment (GRA) - Randomized Portion
Summary statistics of GRA at different cycling settings are provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved). Percentages of subjects reported worse, same or better under each cycling setting since starting the study are presented.
Time frame: 4 weeks
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Number of UUI Episodes Per Day - no Stimulation
UUI episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.
Time frame: 4 Weeks
Degree of Urgency - no Stimulation
Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.
Time frame: 4 weeks
Number of Pads Used Per Day - no Stimulation
Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.
Time frame: 4 Weeks
Global Response Assessment - no Stimulation
Summary of GRA under no stimulation setting is provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).
Time frame: 4 Weeks
Adverse Events - no Stimulation
Summary of adverse device effects when subjects were under no stimulation is provided. Percentage of subjects experiencing any type of Adverse Device Effect under no stimulation is presented.
Time frame: 4 Weeks