Obstetric Anal Sphincter Injury, Vaginal Electrical Stimulation
Conditions
Keywords
Apex M, Postpartum, Pelvic Floor rehabilitation
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.
Interventions
DEVICEApexM (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.
DEVICESham 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.
Sponsors
Evergreen Invitational
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anal Incontinence | 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
| Measure | Time frame | Description |
|---|---|---|
| Urinary Incontinence | 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). |
| Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis | 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. |
| Number of Patients With Anal Sphincter Muscle Defects | 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. |
| Maximum Squeeze Anal Pressure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 26 |
| 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.
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. | 22 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 7 | 11 |
Baseline characteristics
| Characteristic | Sham Device | Total | ApexM Device |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 48 Participants | 26 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 4 | 33 years STANDARD_DEVIATION 4 | 32 years STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 32 Participants | 11 Participants |
| Region of Enrollment United States | 22 participants | 48 participants | 26 participants |
| Sex: Female, Male Female | 22 Participants | 48 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 22 |
| other Total, other adverse events | 2 / 26 | 0 / 22 |
| serious Total, serious adverse events | 0 / 26 | 0 / 22 |
Outcome results
Primary
Anal Incontinence
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.
Time frame: 13 weeks postpartum
Population: Between February 2016 and September 2018, 48 women completed 13-week follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ApexM Device | Anal Incontinence | 12 Scores on a scale |
| Sham Device | Anal Incontinence | 4 Scores on a scale |
p-value: 0.04Wilcoxon (Mann-Whitney)
Secondary
Maximum Squeeze Anal Pressure
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
Time frame: 13 weeks postpartum
Population: Between February 2016 and September 2018, 48 women completed 13-week follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ApexM Device | Maximum Squeeze Anal Pressure | 108.4 mm/Hg | Standard Deviation 36.2 |
| Sham Device | Maximum Squeeze Anal Pressure | 113.3 mm/Hg | Standard Deviation 17.7 |
p-value: 0.88Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis
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.
Time frame: 13 weeks postpartum
Population: Between February 2016 and September 2018, 48 women completed 13-week follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ApexM Device | Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis | 8 Participants |
| Sham Device | Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis | 7 Participants |
Secondary
Number of Patients With Anal Sphincter Muscle Defects
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.
Time frame: 13 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ApexM Device | Number of Patients With Anal Sphincter Muscle Defects | 12 Participants |
| Sham Device | Number of Patients With Anal Sphincter Muscle Defects | 10 Participants |
Secondary
Urinary Incontinence
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).
Time frame: 1 week postpartum and 13 weeks postpartum
Population: Between February 2016 and September 2018, 30 women completed the UDI-6 at two time points (1 week \& 13 week postpartum).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ApexM Device | Urinary Incontinence | 13 Week Postpartum | 5 Participants |
| ApexM Device | Urinary Incontinence | 1 week Post Partum | 8 Participants |
| Sham Device | Urinary Incontinence | 1 week Post Partum | 8 Participants |
| Sham Device | Urinary Incontinence | 13 Week Postpartum | 9 Participants |