Improving Female Sexual Wellness

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Commercial Genital Vibrators Use on Female Wellness

Conditions
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Sexuality, Sexual Dysfunction, Sexual Desire Disorder, Hypoactive Sexual Desire Disorder, Orgasmic Disorder, Pelvic Organ Prolapse, Urinary Incontinence, Interstitial Cystitis, Pelvic Floor Disorders, Female Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Vibrator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Diagnosis of female sexual dysfunction, pelvic floor dysfunction, genito-urologic issues (stress urinary incontinence, urge urinary incontinence, pelvic organ prolapse, interstitial cystitis, pelvic pain, dyspareunia, lichen sclerosis) Manual dexterity to use vibrator Exclusion Criteria: Non English speaking Pregnancy or <12 months postpartum Poor manual dexterity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrator<br>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. | Behavioral: Vibrator<br>* Clitoral stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexuality, Sexual Dysfunction, Sexual Desire Disorder, Hypoactive Sexual Desire Disorder, Orgasmic Disorder, Pelvic Organ Prolapse, Urinary Incontinence, Interstitial Cystitis, Pelvic Floor Disorders, Wellness, Female Sexual Dysfunction