Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery

NACompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

February 26, 2016

Primary Completion Date

December 31, 2019

Study Completion Date

January 31, 2020

Conditions
Obstetric Anal Sphincter InjuryVaginal Electrical Stimulation
Interventions
DEVICE

ApexM (Stimulation) Device

Vaginal electrical stimulation will be administered via the Apex M Device. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Stimulation session will last 10 minutes and occur 6 times per week for a total of 12 weeks.

DEVICE

Sham Device

A sham Apex M device without electrical stimulation will be used. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Each session will last 10 minutes and occur 6 times per week for a total of 12 weeks.

Trial Locations (1)

60611

Northwestern Medical Group's Integrated Pelvic Health Program, Chicago

All Listed Sponsors
collaborator

Evergreen Invitational

UNKNOWN

lead

Northwestern University

OTHER

NCT02701413 - Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery | Biotech Hunter | Biotech Hunter