Improving Female Sexual Wellness

Effect of Commercial Genital Vibrators Use on Female Wellness

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Sexual Dysfunction; Pelvic Organ Prolapse; Pelvic Floor Disorders; Interstitial Cystitis; Female Sexual Dysfunction; Hypoactive Sexual Desire Disorder; Sexuality; Orgasmic Disorder; Sexual Desire Disorder
• Intervention / Treatment: Behavioral: Vibrator

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Karyn Eilber, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 5, 2023

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; Female Sexual Dysfunction; Urinary Incontinence; Pelvic Floor Disorders; Interstitial Cystitis; sexuality; Hypoactive Sexual Desire Disorder; Sexual Dysfunction; Wellness; Sexual Desire Disorder; Orgasmic Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Dyskinesias; Pregnancy Complications; Elimination Disorders; Disease; Cystitis; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis; Pelvic Floor Disorders; Cystitis, Interstitial; Hypokinesia; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: 00001138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No