Overactive Bladder, Fecal Incontinence, Urinary Retention
Conditions
Brief summary
To collect physiological signals at several timepoints during the therapy evaluation period.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this non-applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Interventions
DEVICESacral Neuromodulation
Sacral neuromodulation delivers electrical stimulation to a sacral nerve
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Overactive Bladder Criteria Inclusion Criteria 1. 18 years of age or older 2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\* requiring an advanced evaluation 3. Willing and able to provide signed and dated informed consent 4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol 5. Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation 6. For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in the first 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion) of the voiding diary. 7. For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day within the first 72 hours of the voiding diary. Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study. Non-Obstructive Urinary Retention Inclusion Criteria 1. 18 years of age or older 2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\* requiring an advanced evaluation 3. Willing and able to provide signed and dated informed consent 4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol 5. Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation 6. Have a diagnosis of non-obstructive urinary retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions. Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study. Fecal Incontinence Inclusion Criteria 1. 18 years of age or older 2. Candidate for or undergoing Medtronic InterStim lead implant labeled indication\* requiring an advanced evaluation 3. Willing and able to provide signed and dated informed consent 4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol 5. Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation 6. Have a diagnosis of fecal incontinence as demonstrated by 3-day a bowel diary as greater than or equal to 1 incontinent episode of more than staining (i.e., either slight, moderate, or severe soiling) Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.
Exclusion criteria
Overactive Bladder Criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with physiological signals collected at each timepoint | 1 day to 7 months | The proportion of subjects with evaluable signals will be summarized at each timepoint |
Countries
United States
Contacts
CONTACTKatherine Peterson
STUDY_DIRECTORKatherine Peterson
Medtronic Pelvic Health
Outcome results
None listed