N/A
N=66
Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
Obstetric Anal Sphincter Injury · Vaginal Electrical Stimulation
Bottom Line
View on ClinicalTrials.gov: NCT02701413 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Anal Incontinence — 12; 4 Scores on a scale — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ApexM (Stimulation) Device (Device); Sham Device (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anal Incontinence |
12; 4 | 0.04 sig |
| SECONDARY Urinary Incontinence |
8; 8; 5; 9 | — |
| SECONDARY Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis |
8; 7 | — |
| SECONDARY Number of Patients With Anal Sphincter Muscle Defects |
12; 10 | — |
| SECONDARY Maximum Squeeze Anal Pressure |
108.4; 113.3 | 0.88 |
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
Data sourced from ClinicalTrials.gov (NCT02701413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.