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To collect physiological signals at several timepoints during the therapy evaluation period.
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic health Electrically Evoked Recording (PEER) 2 Study | Experimental | Collect physiological signals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacral Neuromodulation | Device | Sacral neuromodulation delivers electrical stimulation to a sacral nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with physiological signals collected at each timepoint | The proportion of subjects with evaluable signals will be summarized at each timepoint | 1 day to 7 months |
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Inclusion Criteria:
Overactive Bladder Criteria Inclusion Criteria
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
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
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 Exclusion Criteria
Non-Obstructive Urinary Retention Exclusion Criteria
Fecal Incontinence Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Peterson | Contact | 414-704-4065 | katherine.r.peterson@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Katherine Peterson | Medtronic Pelvic Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Research Institute | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D005242 | Fecal Incontinence |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| LSUHSC Department of Urology | Withdrawn | New Orleans | Louisiana | 70112 | United States |
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70121 | United States |
|
| Mayo Clinic Urology/Urogynecology Department | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| OhioHealth Physician's Group Urology | Recruiting | Hilliard | Ohio | 43026-2050 | United States |
|
| DHR Health Institute for Research and Development | Completed | Edinburg | Texas | 78539 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014555 | Urination Disorders |