Overactive Bladder, Urgency-frequency Syndrome, Urinary Urge Incontinence
Conditions
Keywords
Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome
Brief 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.
Interventions
DEVICEInterStim Basic Evaluation lead and foramen needle
Commercial devices within their intended use as described in approved Instructions for Use.
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim Basic Evaluation Lead.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects 18 years of age or older 2. Candidate for sacral neuromodulation in accordance with the InterStim System labeling 3. Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary 4. Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol 5. Willing and able to provide signed and dated informed consent
Exclusion criteria
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 2. Have implantable pacemakers, or defibrillators 3. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 4. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the InterStim System labeling 5. Women who are pregnant or planning to become pregnant during participation in the study 6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements 7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor or Sensory Response(s) During Lead Placement - by Subject | During lead implant procedure (approximately 20 minutes) | To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed. |
Countries
Canada, Netherlands, United Kingdom, United States
Participant flow
Pre-assignment details
Subjects were considered to be 'enrolled' in the study at the time of the BE Lead procedure.
Participants by arm
| Arm | Count |
|---|---|
| Baseline Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Baseline |
|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 14.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 70 Participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 134 |
| other Total, other adverse events | 3 / 110 |
| serious Total, serious adverse events | 1 / 134 |
Outcome results
Primary
Motor or Sensory Response(s) During Lead Placement - by Subject
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big toe) was observed.
Time frame: During lead implant procedure (approximately 20 minutes)
Population: Subjects with overactive bladder who went through InterStim basic evaluation with the commercially approved foramen needle and basic evaluation kit (110) were included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Motor or Sensory Response of Lead | Motor or Sensory Response(s) During Lead Placement - by Subject | Yes | 107 Participants |
| Motor or Sensory Response of Lead | Motor or Sensory Response(s) During Lead Placement - by Subject | No | 3 Participants |
| Motor or Sensory Response of Needle | Motor or Sensory Response(s) During Lead Placement - by Subject | Yes | 109 Participants |
| Motor or Sensory Response of Needle | Motor or Sensory Response(s) During Lead Placement - by Subject | No | 1 Participants |