Female Sexual Dysfunction (FSD), Hypoactive Sexual Desire Disorder (HSDD), Low Libido
Conditions
Keywords
Female Sexual Dysfunction (FSD), Hypoactive Sexual Desire Disorder (HSDD), Low libido, Acupuncture
Brief summary
Female Sexual Dysfunction (FSD) affects up to 43% of women in the United States and Hypoactive Sexual Desire Disorder (HSDD) is the most common form. There is no standardized treatment for this condition. We know that alternative therapies such as acupuncture have been beneficial to women suffering from urinary incontinence, chronic lower back pain, and migraines. We hypothesize that the quality of life for premenopausal women with hypoactive sexual desire disorder (HSDD) will improve with initiation of acupuncture therapy for a duration of 5-weeks. Validated questionnaires are administered at the time of enrollment and 1 week after the final acupuncture session as the method of analyzing our primary outcome.
Detailed description
Each woman will receive experimental therapy with acupuncture twice a week for five weeks and complete a packet of validated questionnaires/surveys at the 1st visit in person and at week 6 by mail. The acupuncture sessions include: * An Initial Evaluation in which the certified acupuncturist will take a * History including: chief complaint, diet, level of diaphoresis, water intake, digestive function, menstrual cycling, sleep habits, overall mood * Physical Exam: inspection of tongue and palpation of pulse * 25 minutes of resting quietly with acupuncture needles in place * Needle usage: from8 to 20 needles are typically used, with an average of 14 per session * Needles are typically placed on the scalp, lower abdomen, elbows and knees Subsequent Sessions (9 more) with the certified acupuncturist * 25 minute each, twice weekly, for 5 weeks = total 10 sessions * Needle usage = 8-20, average 14 per session * Typically placed on the scalp, lower abdomen, elbows and knees The questionnaires/surveys include questions about: * Sexual desire, arousal, lubrication, orgasm, satisfaction and pain * General physical health * General emotional and psychological health * Social relationships
Interventions
PROCEDUREAcupuncture
Acupuncture Therapy - Initial Evaluation History including: chief complaint, diet, level of diaphoresis, water intake, digestive function, menstrual cycling, sleep habits, overall mood. Physical Exam: inspection of tongue and palpation of central and peripheral pulses. Chinese Diagnoses for Female Sexual Dysfunction: Kidney Yang Deficiency; Liver Qi Stagnation; Generalized Blood Deficiency; Spleen Yang Deficiency; Heart Fire \- Subsequent Sessions 25 minute sessions, twice weekly, for 5 weeks = total 10 sessions Needle usage = 8-20, average 14 per session Typically placed on the scalp, lower abdomen, elbows and knees
Sponsors
TriHealth Medical Education Research Fund
TriHealth Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-55 years * Sexually Active * Premenopausal * Documented diagnosis of HSDD as primary cause of FSD (defined as a non adjusted score of ≤ 6 in the desire domain of the FSFI questionnaire)
Exclusion criteria
* Postmenopausal, defined as absence of menstruation in the prior 12 months * Pain or dyspareunia as the primary cause of FSD (defined as a non adjusted score of ≤ 6 in the pain domain of the FSFI) * History of hysterectomy and/or oophorectomy * History of chemotherapy, or pelvic irradiation * Use of hormonal contraception or oral hormone replacement therapy * Active skin infection or disease * Blood dyscrasia * Allergy to acupuncture needles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) | 6 weeks | Determined by a change in the desire domain of the Female Sexual Function Index (FSFI) from baseline at enrollment to study completion at 6 weeks after initiation of intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Distress Scale (FSDS-R) | 6 weeks | Determined by functional data points distributed at enrollment and 6 weeks: Female Sexual Distress scale - revised (FSDS-R) |
| Short Form-12 (SF-12) | 6 weeks | Determined by functional data points distributed at enrollment and 6 weeks: Short Form-12 (SF-12) |
| Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9) | 6 weeks | Determined by functional data points distributed at enrollment and 6 weeks: Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9) |
| World Health Organization Quality of Life- BREF (WHOQOL) | 6 weeks | Determined by functional data points distributed at enrollment and 6 weeks: World Health Organization Quality of Life- BREF (WHOQOL) |
| Patient Global Impression of Improvement (PGI-I) | 6 weeks | Determined by functional data points distributed at enrollment and 6 weeks: Patient Global Impression of Improvement (PGI-I) |
Countries
United States
Outcome results
None listed