Trial Outcomes & Findings for Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery (NCT NCT02701413)

Last Updated: 2021-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

13 weeks postpartum

Results posted on

2021-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	33	33
Overall Study COMPLETED	26	22
Overall Study NOT COMPLETED	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	7	11

Baseline Characteristics

Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ApexM Device n=26 Participants 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.	Sham Device n=22 Participants 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.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 4 • n=5 Participants	34 years STANDARD_DEVIATION 4 • n=7 Participants	33 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	21 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	22 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks postpartum

Population: Between February 2016 and September 2018, 48 women completed 13-week follow up.

Outcome measures

Outcome measures
Measure	ApexM Device n=26 Participants 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.	Sham Device n=22 Participants 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.
Anal Incontinence	12 Scores on a scale Interval 0.0 to 23.0	4 Scores on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	ApexM Device n=13 Participants 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.	Sham Device n=17 Participants 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.
Urinary Incontinence 13 Week Postpartum	5 Participants	9 Participants
Urinary Incontinence 1 week Post Partum	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 13 weeks postpartum

Population: Between February 2016 and September 2018, 48 women completed 13-week follow up.

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.

Outcome measures

Outcome measures
Measure	ApexM Device n=26 Participants 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.	Sham Device n=22 Participants 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.
Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis	8 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ApexM Device n=26 Participants 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.	Sham Device n=22 Participants 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.
Number of Patients With Anal Sphincter Muscle Defects	12 Participants	10 Participants

SECONDARY outcome

Timeframe: 13 weeks postpartum

Population: Between February 2016 and September 2018, 48 women completed 13-week follow up.

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

Outcome measures

Outcome measures
Measure	ApexM Device n=26 Participants 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.	Sham Device n=22 Participants 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.
Maximum Squeeze Anal Pressure	108.4 mm/Hg Standard Deviation 36.2	113.3 mm/Hg Standard Deviation 17.7

Adverse Events

ApexM Device

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ApexM Device n=26 participants at risk 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.	Sham Device n=22 participants at risk 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.
Infections and infestations UTI	3.8% 1/26 • Number of events 1 • Adverse event data was collected over 12 weeks of study participation (Baseline= 1 week postpartum and the end point was 13 weeks postpartum) starting from February 2016 and ending in September 2018.	0.00% 0/22 • Adverse event data was collected over 12 weeks of study participation (Baseline= 1 week postpartum and the end point was 13 weeks postpartum) starting from February 2016 and ending in September 2018.
Skin and subcutaneous tissue disorders Pain	3.8% 1/26 • Number of events 1 • Adverse event data was collected over 12 weeks of study participation (Baseline= 1 week postpartum and the end point was 13 weeks postpartum) starting from February 2016 and ending in September 2018.	0.00% 0/22 • Adverse event data was collected over 12 weeks of study participation (Baseline= 1 week postpartum and the end point was 13 weeks postpartum) starting from February 2016 and ending in September 2018.

Additional Information

Dr. Christina Lewicky-Gaupp

Northwestern University

Phone: 312-472-3874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place