Improving Female Sexual Wellness
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|ClinicalTrials.gov Identifier: NCT04824820|
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : July 19, 2022
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|Condition or disease||Intervention/treatment||Phase|
|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||Behavioral: Vibrator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Commercial Genital Vibrators Use on Female Wellness|
|Actual Study Start Date :||April 10, 2021|
|Estimated Primary Completion Date :||February 9, 2023|
|Estimated Study Completion Date :||May 9, 2023|
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.
- To assess the change from baseline sexual function at 3 month [ Time Frame: 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 sexual function at 3 month [ Time Frame: baseline, post intervention at 3 months ]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.
- To assess the change from baseline degree of pelvic organ prolapse at 3 month [ Time Frame: 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 [ Time Frame: 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.
- To assess the change from baseline overall health and quality of life at 3 month [ Time Frame: baseline, post intervention at 3 months ]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.
- To assess the change from baseline overall health and quality of life at 3 month [ Time Frame: baseline, post intervention at 3 months ]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.
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|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- Non English speaking
- Pregnancy or <12 months postpartum
- Poor manual dexterity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824820
|Contact: Alexandra Dubinskaya, MDemail@example.com|
|United States, California|
|Cedars Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Alexandra Dubinskaya, MD 347-220-5754 firstname.lastname@example.org|
|Contact: Karyn Eilber, MD email@example.com|
|Principal Investigator:||Karyn Eilber, MD||Cedars-Sinai Medical Center|
|Responsible Party:||Karyn Eilber, Female Pelvic Medicine & Reconstructive Surgery Chair, Cedars-Sinai Medical Group Department of Surgery Associate Professor, Urology and Obstetrics & Gynecology, Cedars-Sinai Medical Center|
|Other Study ID Numbers:||
|First Posted:||April 1, 2021 Key Record Dates|
|Last Update Posted:||July 19, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Sexual Desire Disorder
Hypoactive Sexual Desire Disorder
Pelvic Organ Prolapse
Pelvic Floor Disorders
Female Sexual Dysfunction
Pelvic Floor Disorders
Pelvic Organ Prolapse
Sexual Dysfunctions, Psychological
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Nervous System Diseases