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Completed

NCT Number: NCT02701413

Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery

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.

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Key information

Conditions

Obstetric Anal Sphincter Injury Vaginal Electrical Stimulation

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medical Group's Integrated Pelvic Health Program

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ApexM (Stimulation) Device

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.

Sham device

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.

Primary outcomes

  1. Anal Incontinence

    Time frame: 13 weeks postpartum

    The FISI is a validated instrument for assessing fecal incontinence symptom severity. The questionnaire contains 4 questions that assess the frequency of incontinence of solid stool, liquid stool, mucus and gas. FISI total scores range from 0-61 points and higher scores on the scale indicate greater severity of anal incontinence symptoms (worse symptoms). The following are ranges of the scores for each subscale, similarly higher scores on the scale indicate greater severity of subtype of anal incontinence (worse symptoms) Gas subscale- 0-12 points Mucus subscale: 0- 12 points Liquid stool subscale: 0-19 points Solid stool subscale: 0-18 points There are units for the scores on the scale. The Total FISI score is derived from the sum of all the scores on the subscales.

Secondary outcomes

  1. Urinary Incontinence

    Time frame: 1 week postpartum and 13 weeks postpartum

    Stress Urinary Incontinence will be compared between the electrical stimulation and sham group by comparing the proportion of women who answer "yes" to the question that corresponds to the presence of stress urinary incontinence (question 17) on the validated questionnaire (Urinary Distress Inventory - 6 (UDI-6).

  2. Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis

    Time frame: 13 weeks postpartum

    Endovaginal ultrasound will be used to determine the relationship between levator ani muscle defects between the electrical stimulation and sham group.

    We defined levator ani defect as the separation (avulsion) of any of the levator muscles from one of their primary attachment sites on ultrasound.

    For levator ani defects, the presence or absence of levator ani avulsion (separation from the pubic bone) will be noted on each side. Number of patients with and without these avulsions defects will be compared between the two groups.

  3. Number of Patients With Anal Sphincter Muscle Defects

    Time frame: 13 weeks postpartum

    For anal sphincter muscle defects, the number of patients with anal sphincter muscles (out of 360 degrees) will be reported. The proportion of patients with anal sphincter defects in each group will be compared between the two groups.

  4. Maximum Squeeze Anal Pressure

    Time frame: 13 weeks postpartum

    Anal manometry will be used to obtain the maximum squeeze pressures and this will be compared between the electrical stimulation and sham group. Anorectal manometry was performed using a microtipped transducer anorectal manometry system with Laborie software and a 4-channel Gaeltec catheter (Laborie Medical Technologies Co., Williston, VT, and Unisensor, Inc, Hampton, NH). Maximum squeeze pressures at 1, 2, 3, 4, and 5cm proximal to the anal verge were recorded in the semi recumbent position. Maximum squeeze pressure was defined as the highest pressure recorded above the baseline (zero) at any level of the anal canal during maximum squeeze effort by the patient

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Evergreen Invitational

Registry information

Acronym: VESPR

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 8, 2016
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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