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
Conditions
Keywords
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
Brief summary
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.
Interventions
BEHAVIORALVibrator
Clitoral stimulation
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the change from baseline sexual function at 3 month | baseline, post intervention at 3 months | 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). |
| To assess the change from baseline degree of pelvic organ prolapse at 3 month | baseline, post intervention at 3 months | 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. |
| To assess the change from baseline overall health and quality of life at 3 month | baseline, post intervention at 3 months | 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. |
Countries
United States
Outcome results
None listed