Trial Outcomes & Findings for Surface Stimulation for Female Sexual Dysfunction (NCT NCT02692417)
NCT ID: NCT02692417
Last Updated: 2019-04-09
Results Overview
Sexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.
COMPLETED
NA
16 participants
6 weeks after beginning of treatment
2019-04-09
Participant Flow
Participant milestones
| Measure |
Posterior Tibial Nerve Stimulation Group
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
Dorsal Genital Nerve Stimulation Group
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Posterior Tibial Nerve Stimulation Group
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
Dorsal Genital Nerve Stimulation Group
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Surface Stimulation for Female Sexual Dysfunction
Baseline characteristics by cohort
| Measure |
Posterior Tibial Nerve Stimulation Group
n=8 Participants
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
Dorsal Genital Nerve Stimulation Group
n=7 Participants
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
BMI
|
27.1 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 4.5 • n=7 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Relationship Status
Single
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Relationship Status
Nonmarried relationship
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Relationship Status
Married
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
On prescription antidepressant
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Baseline FSFI
|
18.4 score on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
16.0 score on a scale
STANDARD_DEVIATION 5.3 • n=7 Participants
|
17.3 score on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Baseline SF-36
|
78.8 units on a scale
STANDARD_DEVIATION 15.3 • n=5 Participants
|
87.4 units on a scale
STANDARD_DEVIATION 4.2 • n=7 Participants
|
82.8 units on a scale
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Baseline AUASI
|
8.6 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after beginning of treatmentSexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.
Outcome measures
| Measure |
Posterior Tibial Nerve Stimulation Group
n=3 Participants
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
Dorsal Genital Nerve Stimulation Group
n=6 Participants
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
|---|---|---|
|
6 Weeks - Total FSFI Score
|
26.0 score on a scale
Standard Deviation 7.8
|
17.4 score on a scale
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: 12 weeks after beginning of treatmentSexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.
Outcome measures
| Measure |
Posterior Tibial Nerve Stimulation Group
n=3 Participants
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
Dorsal Genital Nerve Stimulation Group
n=6 Participants
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
|---|---|---|
|
12 Weeks - Total FSFI Score
|
27.8 score on a scale
Standard Deviation 4.8
|
18.7 score on a scale
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: 18 weeks after start of treatmentSexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.
Outcome measures
| Measure |
Posterior Tibial Nerve Stimulation Group
n=3 Participants
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
Dorsal Genital Nerve Stimulation Group
n=6 Participants
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
|---|---|---|
|
18 Weeks - Total FSFI Score
|
26.2 score on a scale
Standard Deviation 8.6
|
18.8 score on a scale
Standard Deviation 5.4
|
Adverse Events
Posterior Tibial Nerve Stimulation Group
Dorsal Genital Nerve Stimulation Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Posterior Tibial Nerve Stimulation Group
n=9 participants at risk
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over their posterior tibial nerve, that is in the area of the ankle, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
Dorsal Genital Nerve Stimulation Group
n=7 participants at risk
Subjects in this group will have transcutaneous electrical nerve stimulation electrodes placed on the skin surface over the dorsal genital nerve, that is above and/or on the lateral side of the clitoris, and receive stimulation for 30 minutes in weekly sessions for 12 weeks.
Transcutaneous Electrical Nerve Stimulation: Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
|
|---|---|---|
|
Nervous system disorders
Sciatic Nerve Pain
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected until the final survey (18 weeks after start of stimulation) was collected.
|
0.00%
0/7 • Adverse event data was collected until the final survey (18 weeks after start of stimulation) was collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place