Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery (VESPR)

Northwestern University

Status: Completed

Conditions: Vaginal Electrical Stimulation; Obstetric Anal Sphincter Injury

Treatments: Device: Sham Device; Device: ApexM (Stimulation) Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02701413

STU00201026

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primiparous (First delivery)
• Women who sustain Obstetric Anal Sphincter Injury (OASIS) during first vaginal delivery
• Between age of 18 - 50 years
• English speaking and reading

Exclusion criteria

• Implanted electrical device or cardiac arrhythmia
• Neurological disorder
• Inflammatory bowel disease
• Chronic Steroid Use
• Wound breakdown and infection
• Anticipated geographic relocation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups

ApexM Device

Experimental group

Description:

The ApexM Device (InControl Medical) is a cylindrical inflatable instrument with electrodes on the dorsal and ventral sides. It is a battery operated, non-implanted device which will be inserted into the vagina and will stimulate the pelvic floor muscles. This device has been shown to be safe and effective for clinical use. Stimulation will alternate between 13 and 50Hz. The initial intensity will be set by the clinician at the patient's initial visit and will be increased in a standard fashion over the duration of the trial.

Treatment:

Device: ApexM (Stimulation) Device

Sham Device

Sham Comparator group

Description:

The ApexM Device will be identical in every way but the electrical stimulation will be disabled. The device will still turn on and inflate to fit the contours of the vagina.

Treatment:

Device: Sham Device