At a glance
ClinicalIndex Comparison RecordN/ACompleted· 97 enrolled
Drug / intervention
InterStim Therapydevice
Likely dose
Not stated in record
Key inclusion· 5
- ✓Primary diagnosis of urinary urge incontinence with ≥3 UUI episodes on 3-day voiding diary
- ✓Female subjects 18 years of age or older
- ✓Candidate for InterStim Lead Placement
- ✓Able to complete voiding diaries, questionnaires, attend visits, and comply with protocol including maintenance of InterStim II programming
Key exclusion· 8
- ✕Neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy, or spinal cord injury
- ✕Diabetes unless well-controlled through diet and/or medications
- ✕Symptomatic urinary tract infection
- ✕Primary stress incontinence or mixed incontinence where stress component overrides urge component
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
InterStim® Amplitude Study
In Brief
A clinical study evaluating InterStim Therapy for Urinary Urge Incontinence. Completed, enrolled 97 participants across 18 sites in 7 countries.
Detailed Summary
This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Urge Incontinence
CountriesBelgium, Canada, France, Italy, Netherlands, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartFeb 2018
Primary CompletionNov 2019
TodayJul 2026
First PostedNov 8, 2017
Enrollment StartFeb 27, 2018
Primary CompletionNov 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.7 years ago
Interventions
InterStim Therapydevice
Device Programming