At a glance
ClinicalIndex Comparison RecordN/ACompleted· 110 enrolled
Drug / intervention
InterStim Basic Evaluation lead and foramen needledevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
In Brief
A clinical study evaluating InterStim Basic Evaluation lead and foramen needle for Overactive Bladder and 2 related conditions. Completed, enrolled 110 participants across 15 sites in 4 countries.
Detailed Summary
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Netherlands, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartNov 2019
Primary CompletionOct 2020
Study CompletionOct 2020
TodayJul 2026
First PostedJul 11, 2019
Enrollment StartNov 28, 2019
Primary CompletionOct 6, 2020
Study CompletionOct 9, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.0 years ago
Interventions
InterStim Basic Evaluation lead and foramen needledevice
Commercial devices within their intended use as described in approved Instructions for Use.