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The purpose of this study is to assess the effect of commercially available genital vibrator use on sexual health, female pelvic floor disorders, and overall quality of life among a diverse population of women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibrator | Experimental | Participants will be using commercially available genital vibrator for at least 5 minutes and/or reaching an orgasm three times a week for 3-4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrator | Behavioral | Clitoral stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the change from baseline sexual function at 3 month | Assessment based on validated questionnaire. Female Sexual Function Index (FSFI), a 19-item measure of sexual function in all four domains: desire, arousal, orgasm and sexual pain. The total score ranges from 0-36, with higher scores indicating better sexual function. Total score below 26.6 indicates clinical Female Sexual Dysfunction (FSD). | baseline, post intervention at 3 months |
| To assess the change from baseline sexual function at 3 month | Assessment based on validated questionnaire. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire International Urogynecological Association (IUGA) Revised (PISQ-IR) is a validated measure of sexual function among not only sexually active women but also sexually inactive women. This questionnaire contains 20 questions, and is used to assess sexual activity in women with urinary incontinence and pelvic organ prolapse. The higher the score the better the Sexual Function. | baseline, post intervention at 3 months |
| To assess the change from baseline degree of pelvic organ prolapse at 3 month | The Pelvic Organ Prolapse Quantifications System (POP-Q) is a system for assessing the degree of prolapse of pelvic organs to help standardize diagnosing, comparing, documenting, and sharing of clinical findings. This assessment is the most frequently used among research publications related to pelvic organ prolapse. | baseline, post intervention at 3 months |
| To assess the change from baseline overall health and quality of life at 3 month | Self-reported quality of life (SF-12) is a general health measure assessing the impact of health on an individual's everyday life. The SF-12 consists of eight domains and generates two separate summary scores, physical functional scores (PCS) and mental function scores (MCS), ranging from 0 to 100. Higher scores indicated better health related quality of life. | baseline, post intervention at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karyn Eilber, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D056887 | Pelvic Organ Prolapse |
| D014549 | Urinary Incontinence |
| D018856 | Cystitis, Interstitial |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C509515 | Vib protein, Drosophila |
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| To assess the change from baseline overall health and quality of life at 3 month | Patient Health Questionnaire (PHQ-9) is a tool to assess depression. The severity of depression is assessed by summarizing the scores assigned to the categories, with score ranging between 1 and 27, with higher score correlating with more sever depression. | baseline, post intervention at 3 months |
| To assess the change from baseline overall health and quality of life at 3 month | The Pelvic Floor Distress Inventory Questionnaire (PFDI) is a condition-specific quality-of-life questionnaire for women with bowel, bladder, and/or pelvic symptoms. The scores range between 0 to 300 with higher scores indicating more severe distress. | baseline, post intervention at 3 months |
| D001523 |
| Mental Disorders |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D011248 | Pregnancy Complications |