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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
Sponsor:
Information provided by (Responsible Party):
Karyn Eilber, Cedars-Sinai Medical Center

Study Description
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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.

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vibrator
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
Clitoral stimulation


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Alexandra Dubinskaya, MD 3472205754 alexandra.dubinskaya@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Alexandra Dubinskaya, MD    347-220-5754    alexandra.dubinskaya@cshs.org   
Contact: Karyn Eilber, MD       karyn.eilber@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Karyn Eilber, MD Cedars-Sinai Medical Center
More Information
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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
ClinicalTrials.gov Identifier: NCT04824820    
Other Study ID Numbers: 00001138
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karyn Eilber, Cedars-Sinai Medical Center:
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
Additional relevant MeSH terms:
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Hypokinesia
Urinary Incontinence
Enuresis
Cystitis
Cystitis, Interstitial
Pelvic Floor Disorders
Disease
Prolapse
Pelvic Organ Prolapse
Sexual Dysfunctions, Psychological
Pathologic Processes
Urination Disorders
 Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Pregnancy Complications
Dyskinesias
Neurologic Manifestations
Nervous System Diseases