Female Sexual Dysfunction
Conditions
Keywords
hypoactive desire disorder, female sexual dysfunction, genital arousal disorder, sexual, dysfunction, female, arousal, electrical stimulation, transcutaneous electrical stimulation, women
Brief summary
Female sexual dysfunction, including sexual arousal disorder, has a significant clinical impact, affecting millions of women in the United States alone. Peripheral nerve stimulation, such as posterior tibial nerve stimulation (PTNS) and dorsal genital nerve stimulation (DGNS) can modulate neural circuits for bladder and fecal continence. The investigators hypothesize that periodic DGNS and PTNS will modulate autonomic neural circuits and promote improvements in sexual function in women with sexual arousal disorder. Subjects will be randomized to receive one of the stimulation approaches. Subjects will have weekly 30-minute sessions across twelve weeks.
Interventions
DEVICETranscutaneous 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.
Sponsors
Timothy Bruns
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult women ≥ 18 years of age * Sexually active ≥ 1 time per month (≥ 2 times per month preferred) * Score of 19 or less on a 6-question set of the Female Sexual Function Index (FSFI) survey * Neurologically stable * Ambulatory * Capable of giving informed consent * English speaking * Capable and willing to follow study procedures
Exclusion criteria
* Men * Women ≤ 17 years of age * Pregnant or planning to get pregnant during the study period * Clinically diagnosed neurological bladder dysfunction * Prior experience with PTNS or DGNS * Current use of transcutaneous electrical nerve stimulation (TENS) on pelvis, back, or legs * Implanted pacemaker, defibrillator, spinal cord stimulator, or sacral root stimulator * Taking flibanserin * Taking any investigational drug * History of neurologic diseases or impairments * Any other factors that the investigators feel would place the patient at increased risk from this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Weeks - Total FSFI Score | 6 weeks after beginning of treatment | 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. |
| 12 Weeks - Total FSFI Score | 12 weeks after beginning of treatment | 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. |
| 18 Weeks - Total FSFI Score | 18 weeks after start of treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | Dorsal Genital Nerve Stimulation Group | Posterior Tibial Nerve Stimulation Group | Total |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 14.8 | 36.0 years STANDARD_DEVIATION 14.3 | 40.9 years STANDARD_DEVIATION 15 |
| Baseline AUASI | 4.6 units on a scale STANDARD_DEVIATION 2.6 | 8.6 units on a scale STANDARD_DEVIATION 6.4 | 6.7 units on a scale STANDARD_DEVIATION 5.3 |
| Baseline FSFI | 16.0 score on a scale STANDARD_DEVIATION 5.3 | 18.4 score on a scale STANDARD_DEVIATION 5.1 | 17.3 score on a scale STANDARD_DEVIATION 5.2 |
| Baseline SF-36 | 87.4 units on a scale STANDARD_DEVIATION 4.2 | 78.8 units on a scale STANDARD_DEVIATION 15.3 | 82.8 units on a scale STANDARD_DEVIATION 12 |
| BMI | 26.5 kg/m^2 STANDARD_DEVIATION 4.5 | 27.1 kg/m^2 STANDARD_DEVIATION 4.5 | 26.8 kg/m^2 STANDARD_DEVIATION 4.4 |
| On prescription antidepressant | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 4 Participants | 10 Participants |
| Relationship Status Married | 5 Participants | 5 Participants | 10 Participants |
| Relationship Status Nonmarried relationship | 1 Participants | 2 Participants | 3 Participants |
| Relationship Status Single | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 1 / 9 | 0 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
Primary
12 Weeks - Total FSFI Score
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.
Time frame: 12 weeks after beginning of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterior Tibial Nerve Stimulation Group | 12 Weeks - Total FSFI Score | 27.8 score on a scale | Standard Deviation 4.8 |
| Dorsal Genital Nerve Stimulation Group | 12 Weeks - Total FSFI Score | 18.7 score on a scale | Standard Deviation 6.9 |
Comparison: Wilcoxon signed rank test comparing FSFI score from baseline to time point.p-value: 0.109Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon signed rank test comparing FSFI score from baseline to time point.p-value: 0.046Wilcoxon (Mann-Whitney)
Primary
18 Weeks - Total FSFI Score
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.
Time frame: 18 weeks after start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterior Tibial Nerve Stimulation Group | 18 Weeks - Total FSFI Score | 26.2 score on a scale | Standard Deviation 8.6 |
| Dorsal Genital Nerve Stimulation Group | 18 Weeks - Total FSFI Score | 18.8 score on a scale | Standard Deviation 5.4 |
Comparison: Wilcoxon signed rank test comparing FSFI score from baseline to time point.p-value: 0.109Wilcoxon (Mann-Whitney)
p-value: 0.028Wilcoxon (Mann-Whitney)
Primary
6 Weeks - Total FSFI Score
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.
Time frame: 6 weeks after beginning of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Posterior Tibial Nerve Stimulation Group | 6 Weeks - Total FSFI Score | 26.0 score on a scale | Standard Deviation 7.8 |
| Dorsal Genital Nerve Stimulation Group | 6 Weeks - Total FSFI Score | 17.4 score on a scale | Standard Deviation 6.6 |
Comparison: Wilcoxon signed rank test comparing FSFI score from baseline to time point.p-value: 0.109Wilcoxon (Mann-Whitney)
Comparison: Wilcoxon signed rank test comparing FSFI score from baseline to time point.p-value: 0.225Wilcoxon (Mann-Whitney)