Back to resultsImproving Female Sexual Wellness
Primary Purpose
Sexuality, Sexual Dysfunction, Sexual Desire Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibrator
Sponsored by
About this trial
This is an interventional treatment trial for Sexuality focused on measuring 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
Eligibility 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
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vibrator
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04824820
First Posted
March 25, 2021
Last Updated
April 5, 2023
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04824820
Brief Title
Improving Female Sexual Wellness
Official Title
Effect of Commercial Genital Vibrators Use on Female Wellness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
April 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibrator
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vibrator
Intervention Description
Clitoral stimulation
Primary Outcome Measure Information:
Title
To assess the change from baseline sexual function at 3 month
Description
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).
Time Frame
baseline, post intervention at 3 months
Title
To assess the change from baseline sexual function at 3 month
Description
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.
Time Frame
baseline, post intervention at 3 months
Title
To assess the change from baseline degree of pelvic organ prolapse at 3 month
Description
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.
Time Frame
baseline, post intervention at 3 months
Title
To assess the change from baseline overall health and quality of life at 3 month
Description
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.
Time Frame
baseline, post intervention at 3 months
Title
To assess the change from baseline overall health and quality of life at 3 month
Description
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.
Time Frame
baseline, post intervention at 3 months
Title
To assess the change from baseline overall health and quality of life at 3 month
Description
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.
Time Frame
baseline, post intervention at 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karyn Eilber, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Female Sexual Wellness
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