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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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).
- 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).
- 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.
- 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.
- 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.
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
|Contact: Meera Tavathia, M.P.H.||firstname.lastname@example.org|
|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 email@example.com|
|Sub-Investigator: Kimberly Kenton, MD|
|Principal Investigator: Christina Lewicky-Gaupp, MD|
|Sub-Investigator: Margaret Mueller, MD|
|Sub-Investigator: Sarah Collins, MD|
|Principal Investigator:||Christina Lewicky-Gaupp, M.D.||Northwestern University Feinberg School of Medicine|