CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
ApexM (Stimulation) Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02701413
NCT02701413N/ACompleted

Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery

Northwestern University·interventional·Posted Mar 8, 2016·Updated Jun 29, 2021

In Brief

A clinical study evaluating ApexM (Stimulation) Device and Sham Device for Obstetric Anal Sphincter Injury and Vaginal Electrical Stimulation. Completed, enrolled 66 participants across 1 site.

Detailed Summary

For too many women, childbirth results in devastating consequences: involuntary loss of feces or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with severe tears during childbirth may develop these problems. These new mothers avoid leaving home in order to stay close to a toilet, wear protective pads every day, and avoid activities they previously enjoyed such as exercise and sexual intercourse. It is not surprising that many of these women suffer from postpartum depression, and bonding with their newborns is compromised. Fecal and urinary incontinence occur due to injuries to the pelvic nerves and muscles during childbirth. Many researchers have focused on what can be done to prevent these injuries; however, few have investigated how to help the countless women who have already suffered from these injuries to the nerves and muscles. In other fields such as orthopedics and neurology, research shows that electrical stimulation can provoke nerve regeneration after injury. Applying this technology to women who have recently suffered from nerve injury during childbirth could have profound and life-changing effects. Investigators hypothesize that electrical stimulation immediately postpartum will markedly help pelvic nerves regenerate, minimizing rates of fecal and urinary incontinence for this vulnerable population of new mothers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 8, 2016
Enrollment StartFeb 26, 2016
Primary CompletionDec 1, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.3 years ago

Interventions

ApexM (Stimulation) Devicedevice

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.

Sham Devicedevice

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.