overactive bladder syndrome urinary incontinence (UI)
Conditions
Interventions
Patiënt will receive a temporary implant (the study device) during a standard
surgery (Interstim implantation). A number of tests (stimulation of nerves)
will be done with the temporary implant.
Implant
Urinary Incontinence
Sponsors
NeuSpera Medical Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Patient must be eligible for treatment and indicated for the Medtronic InterStim® system or InterStim® II (implantable pulse generator and lead). • Patient wishes to undergo an InterStim® or InterStim® II implant procedure after this acute study. • Patient must be in good general health in the opinion of the Investigator. • Patient is able to understand and has voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures. • Patient must be minimum 18 years and maximum 65 years of age.
Exclusion criteria
Exclusion criteria: • Patient has any of the contraindications for the InterStim® system or InterStim® II system: o Previous sacral surgery o Neurological conditions o Neurogenic bladder o Neurogenic detrusor over activity o Multiple Sclerosis o Spinal cord injury o Stress urinary incontinence o Primary pelvic pain o Pregnant as determined by urine pregnancy test during screening on the day of the procedure or plan to become pregnant o Pelvic trauma o Body Mass Index (BMI) below 18.5 or above 30 o Any other contraindication is left to the Investigator*s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint 1: During the stimulation of the S3 sacral nerve, the investigation team will observe and record movements in the buttocks / natal cleft region and leg / foot region. This should include a bellows response in the pelvic floor along with a big toe (or other toe) flexion. Primary Endpoint 2: Correct placement of the NSM AHLeveeS will be at the investigators discretion. After correct placement a fluoroscopy image will be obtained to capture the correct position. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint: Time in minutes between the end of the stimulation protocol and the moment the NSM AHLeveeS System is explanted from the body. Safety Endpoint: The safety endpoint has been selected due to the fact that this is a first in human study. It will be evaluated by: Recording all Adverse events, Device deficiency*s and Protocol Deviations and the need for additional surgical instruments. | — |
Countries
The Netherlands
Outcome results
None listed