Clinical trial NCT02701413: Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
Official title: Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Anal Sphincter Injury
Vaginal Electrical Stimulation
Keywords: Apex M
Postpartum
Pelvic Floor rehabilitation
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Evergreen Invitational
First posted: 2016-03-08
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Anal Incontinence
timeFrame: 13 weeks postpartum
Secondary outcomes:
measure: Urinary Incontinence
timeFrame: 1 week postpartum and 13 weeks postpartum
measure: Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis
timeFrame: 13 weeks postpartum
measure: Number of Patients With Anal Sphincter Muscle Defects
timeFrame: 13 weeks postpartum
measure: Maximum Squeeze Anal Pressure
timeFrame: 13 weeks postpartum
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Group's Integrated Pelvic Health Program
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Christina Lewicky-Gaupp, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Dis Colon Rectum. 1999 Dec;42(12):1525-32. doi: 10.1007/BF02236199.
citation: Brown O, Heliker BD, Geynisman-Tan J, Tavathia M, Mueller MG, Collins S, Kenton K, Lewicky-Gaupp C. Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):659-666. doi: 10.1097/SPV.0000000000001037.