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Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery (VESPR)

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ClinicalTrials.gov Identifier: NCT02701413
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Evergreen Invitational Women's Health Grants Initiative
Information provided by (Responsible Party):
Christina Lewicky-Gaupp, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Obstetric Anal Sphincter Injury Vaginal Electrical Stimulation Device: ApexM (Stimulation) Device Device: Sham Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
Study Start Date : March 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ApexM Device
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.
Device: ApexM (Stimulation) 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 Comparator: Sham Device
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.
Device: Sham 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 Outcome Measures :
  1. Anal Incontinence [ Time Frame: 13 weeks postpartum ]
    Anal incontinence symptoms will be compared between the electrical stimulation and sham group using a validated questionnaire called the Fecal Incontinence Severity Index (FISI).


Secondary Outcome Measures :
  1. Urinary Incontinence [ Time Frame: Baseline, 5 weeks, 10 weeks, and 13 weeks postpartum ]
    Stress Urinary Incontinence and overall Urinary Incontinence will be compared between the electrical stimulation and sham group using validated questionnaires (Urinary Distress Inventory - 6 (UDI-6).

  2. Levator Ani Muscle Defects [ 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.

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


  3. Anal Sphincter Muscle Defects [ Time Frame: 13 weeks postpartum ]
    For anal sphincter muscle defects, the percentage of defect in the anal sphincter muscles (out of 360 degrees) will be reported. These percentages will be compared between the two groups.

  4. Anal pressures [ Time Frame: Baseline, 13 weeks postpartum ]
    Anal manometry will be used to compare anal resting and squeeze pressures between the electrical stimulation and sham group.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701413


Contacts
Contact: Meera Tavathia, M.P.H. 312-926-7846 meera.tavathia@northwestern.edu

Locations
United States, Illinois
Northwestern Medical Group's Integrated Pelvic Health Program Recruiting
Chicago, Illinois, United States, 60611
Contact: Meera Tavathia, M.P.H.    312-926-7846    meera.tavathia@northwestern.edu   
Sub-Investigator: Kimberly Kenton, MD         
Principal Investigator: Christina Lewicky-Gaupp, MD         
Sub-Investigator: Margaret Mueller, MD         
Sub-Investigator: Sarah Collins, MD         
Sponsors and Collaborators
Northwestern University
Evergreen Invitational Women's Health Grants Initiative
Investigators
Principal Investigator: Christina Lewicky-Gaupp, M.D. Northwestern University Feinberg School of Medicine

Responsible Party: Christina Lewicky-Gaupp, Assistant Professor, Department of Obstetrics & Gynecology, Northwestern University
ClinicalTrials.gov Identifier: NCT02701413     History of Changes
Other Study ID Numbers: STU00201026
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christina Lewicky-Gaupp, Northwestern University:
Apex M
Postpartum
Pelvic Floor rehabilitation