Trial Outcomes & Findings for Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain (NCT NCT02397785)
NCT ID: NCT02397785
Last Updated: 2019-07-26
Results Overview
The Visual Analog Scale assesses self-reported pain scores. Patients were asked to record their average pain over the past 4 weeks by placing an "X" on a 10-cm line, with 0 representing no pain and 100 representing the worst pain imaginable. Pain scores were determined by research personnel by measuring the distance (in mm) from 0 to the X. Change = (Week 12 Score - Baseline Score).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2019-07-26
Participant Flow
Participant milestones
| Measure |
ApexM Device
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
34
|
|
Overall Study
COMPLETED
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain
Baseline characteristics by cohort
| Measure |
ApexM Device
n=24 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=34 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
33.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
BMI
|
27.0 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Employment Status
Employed
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Annual Household Income
<$25,000
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Annual Household Income
$25,001-$50,000
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Annual Household Income
$50,001-$75,000
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Annual Household Income
$75,001-$100,000
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Annual Household Income
>$100,000
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Highest Education Level Completed
< High School
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Highest Education Level Completed
High School / GED
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Highest Education Level Completed
College
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Highest Education Level Completed
Graduate/Professional Degree
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Total Parity
0
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Total Parity
1
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Total Parity
>=2
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Vaginal Parity
|
1.8 Vaginal Births
STANDARD_DEVIATION 1.2 • n=5 Participants
|
1.1 Vaginal Births
STANDARD_DEVIATION 1.3 • n=7 Participants
|
1.3 Vaginal Births
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Menopausal Status
Pre-Menopausal
|
21 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Menopausal Status
Post-Menopausal
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Pain Duration
|
4.9 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
11.0 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
8.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Endometriosis
Yes
|
8 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Endometriosis
No
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
History of Pelvic Floor Physical Therapy
Yes
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
History of Pelvic Floor Physical Therapy
No
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
History of Depression
Yes
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
History of Depression
No
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
History of Sexual Abuse
Yes
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
History of Sexual Abuse
No
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 VAS scores available.
The Visual Analog Scale assesses self-reported pain scores. Patients were asked to record their average pain over the past 4 weeks by placing an "X" on a 10-cm line, with 0 representing no pain and 100 representing the worst pain imaginable. Pain scores were determined by research personnel by measuring the distance (in mm) from 0 to the X. Change = (Week 12 Score - Baseline Score).
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 12
|
-8.5 units on a scale
Standard Deviation 30.9
|
-7.4 units on a scale
Standard Deviation 25.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Short Form 36 (SF-36) Physical Functioning Scale
|
1.4 units on a scale
Standard Deviation 4.1
|
1.6 units on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Physical Health Scale
|
1.13 units on a scale
Standard Deviation 50.9
|
21 units on a scale
Standard Deviation 43.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Emotional Problems Scale
|
-7.6 units on a scale
Standard Deviation 43.5
|
2.7 units on a scale
Standard Deviation 35.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Short Form 36 (SF-36) Energy/Fatigue Scale
|
1.8 units on a scale
Standard Deviation 19.1
|
7.2 units on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Short Form 36 (SF-36) Emotional Wellbeing Scale
|
-2.9 units on a scale
Standard Deviation 12.3
|
0.8 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Short Form 36 (SF-36) Social Function Scale
|
-3.4 units on a scale
Standard Deviation 15.5
|
5.5 units on a scale
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Pain on Short Form 36 (SF-36) Pain Scale
|
5.2 units on a scale
Standard Deviation 21.9
|
18.1 units on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Short Form 36 (SF-36) General Health Scale
|
-3.1 units on a scale
Standard Deviation 9.9
|
0 units on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 BPI scores available.
The Brief Pain Inventory (BPI) is a validated, self-reported instrument used to evaluate pain symptoms within the last 24 hours. The BPI consists of 2 sub-scales: 1) pain severity, 2) pain interference. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-10. Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Severity Scale
|
-0.4 units on a scale
Standard Deviation 2.3
|
-0.4 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 BPI scores available.
The Brief Pain Inventory (BPI) is a validated, self-reported instrument used to evaluate pain symptoms within the last 24 hours. The BPI consists of 2 sub-scales: 1) pain severity, 2) pain interference. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-10. Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Interference Scale
|
-0.06 units on a scale
Standard Deviation 3.2
|
-1.1 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 FSFI scores available.
The Female Sexual Function Index is a validated, self-reported instrument used to evaluate sexual function and symptoms. The FSFI consists of 6 sub-scales: 1) desire \[score range = 1.2 - 6\], 2) arousal \[score range = 0 - 6\], 3) lubrication \[score range = 0 - 6\], 4) orgasm \[score range = 0 - 6\], 5) satisfaction \[score range = 0 - 6\], 6) pain \[score range = 0 - 6\]. The full FSFI consists of 19 questions, and the total score ranges from 1.2 - 36. Change = (Week 12 Score - Baseline Score). Higher scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Female Sexual Function Index (FSFI) Scale
|
2.7 units on a scale
Standard Deviation 8.0
|
1.9 units on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Pelvic Organ Prolapse Distress Inventory (POPDI) Sub-Scale
|
-4.7 units on a scale
Standard Deviation 11.7
|
-9.3 units on a scale
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Colorectal Anal Distress Inventory (CRADI) Sub-Scale
|
-4.1 units on a scale
Standard Deviation 8.6
|
-6.5 units on a scale
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) Sub-Scale
|
-6.3 units on a scale
Standard Deviation 17.6
|
-10 units on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.
The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Outcome measures
| Measure |
ApexM Device
n=22 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=25 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Total Scale
|
-15.2 units on a scale
Standard Deviation 28.8
|
-25.8 units on a scale
Standard Deviation 33.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 medication diaries available.
Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).
Outcome measures
| Measure |
ApexM Device
n=20 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=21 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Weekly Ibuprofen Use
|
200 mg/week
Standard Deviation 836
|
-400 mg/week
Standard Deviation 1201
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 medication diaries available.
Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).
Outcome measures
| Measure |
ApexM Device
n=20 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=21 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Weekly Naprosyn Use
|
-35.3 mg/week
Standard Deviation 250
|
-62.9 mg/week
Standard Deviation 288
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).
Outcome measures
| Measure |
ApexM Device
n=20 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=21 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Weekly Acetaminophen Use
|
125 mg/week
Standard Deviation 559
|
-333 mg/week
Standard Deviation 1238
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.
Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).
Outcome measures
| Measure |
ApexM Device
n=20 Participants
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=21 Participants
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Change From Baseline in Weekly Opioid Use
|
-0.25 morphine equivalents/week
Standard Deviation 1.1
|
0 morphine equivalents/week
Standard Deviation 0
|
Adverse Events
ApexM Device
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Sham Device
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ApexM Device
n=24 participants at risk
InControl Medical created a line of products FDA approved for urinary incontinence and fecal incontinence. These devices are non-implanted, customizable, battery-operated vaginal probes made of medical grade silicone and provide electrical stimulation to the pelvic floor. The ApexM device provides electrical stimulation at frequencies alternating between 13 Hz and 50 Hz and allows the clinician to adjust the intensity as well as the duration of the electrical stimulation. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
Sham Device
n=34 participants at risk
Subjects in the control arm used a sham ApexM device. The original ApexM device was modified to disable its electrical stimulation functionality. Otherwise, the devices are indistinguishable and possess identical dimensions. Although the sham device can be powered "on," the circuitry was disconnected so that electrical stimulation is disabled. Participants were instructed to apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity was set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. Participants were instructed to complete 1 12-minute session at home per day, 6 days per week.
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal Discharge
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
|
Product Issues
Tingling Sensation
|
33.3%
8/24 • Number of events 8 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
0.00%
0/34 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
|
Reproductive system and breast disorders
Pelvic Cramping
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
|
Renal and urinary disorders
Urinary Frequency
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
0.00%
0/34 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
|
Reproductive system and breast disorders
Vaginal Soreness
|
0.00%
0/24 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected for the entire study period for each participant (12 weeks). Following study completion, participants were encouraged to contact the researchers in the event of any future device-related adverse outcome, and they were offered assistance in scheduling follow-up visits with the Chronic Pelvic Pain Center at our institution.
Adverse event reporting was conducted through use of standardized questions asked at the time of each trial visit (every 4 weeks). Additionally, participants were given contact information for multiple methods of reporting adverse events, including contact information for the researchers, the general research nurse office, the on-call gynecologist, and the Institutional Review Board.
|
Additional Information
Erica Magelky, Principal Investigator
Cleveland Clinic Foundation
Phone: 713-628-5357
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place