Pelvic Health Electrically Evoked Recording (PEER) 2 Study

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
MedtronicNeuro
Study ID
NCT05200923
Status
Recruiting
Apply to this trial

Conditions

  • Fecal Incontinence
  • Overactive Bladder
  • Urinary Retention

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacral Neuromodulation — DEVICE
    Sacral neuromodulation delivers electrical stimulation to a sacral nerve

Study Details

To collect physiological signals at several timepoints during the therapy evaluation period.

Key Dates

Start date
Jan 18, 2022
Status verified
Mar 2026
Primary completion
Dec 18, 2026
Completion
Dec 18, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Pelvic health Electrically Evoked Recording (PEER) 2 Study
    Collect physiological signals

Primary Outcome Measure

Number of subjects with physiological signals collected at each timepoint [ Time Frame: 1 day to 7 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Indiana University Health Methodist Research InstituteIndianapolisIndiana46202
Andi Nowakowski
[email protected]
317-278-6752
Charles Powell (PRINCIPAL_INVESTIGATOR)
LSUHSC Department of UrologyNew OrleansLouisiana70112-
Ochsner Clinic FoundationNew OrleansLouisiana70121
Samantha Ahrens
[email protected]
504-842-2455
Colin Goudelocke (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Urology/Urogynecology DepartmentRochesterMinnesota55905
Stacy Wroblewski
[email protected]
507-422-3984
Brian Linder (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Hachem Ziadeh
[email protected]
440-470-8830
David Sheyn (PRINCIPAL_INVESTIGATOR)
Adonis Hijaz (SUB_INVESTIGATOR)
Joseph Henderson (SUB_INVESTIGATOR)
Anne Sammarco (SUB_INVESTIGATOR)
OhioHealth Physician's Group UrologyHilliardOhio43026-2050
Diamond Rapp
[email protected]
740-375-2490
Ketul Shah (PRINCIPAL_INVESTIGATOR)
DHR Health Institute for Research and DevelopmentEdinburgTexas78539-

Find similar trials in Indianapolis, IN

By research site
Indiana University Health Methodist Research Institute· Indianapolis, INLSUHSC Department of Urology· New Orleans, LAOchsner Clinic Foundation· New Orleans, LAMayo Clinic Urology/Urogynecology Department· Rochester, MNUniversity Hospitals Cleveland Medical Center· Cleveland, OHOhioHealth Physician's Group Urology· Hilliard, OH

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