SexualityNCT04824820
Improving Female Sexual Wellness
A study testing Vibrator in people with Sexuality and Sexual Dysfunction, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Sexuality, Sexual Dysfunction, Sexual Desire Disorder
- What is being tested?
- Vibrator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2021to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non English speaking
- Pregnancy or <12 months postpartum
- Poor manual dexterity
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
- Conditions
- Sexuality, Sexual Dysfunction, Sexual Desire Disorder, Hypoactive Sexual Desire Disorder, Orgasmic Disorder, Pelvic Organ Prolapse
- Being tested
- Vibrator
- 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
- Medical subject headings
- Sexuality, Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Pelvic Organ Prolapse, Urinary Incontinence, Cystitis, Interstitial, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibratorBehavioural
Clitoral stimulation
| Study group | Role | What they receive |
|---|---|---|
| Vibrator | Experimental | 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. Receives: Behavioral: Vibrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, post intervention at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start10 Apr 2021
- Primary completion1 Jan 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karyn Eilber, Cedars-Sinai Medical Center
- Investigators
- Karyn Eilber, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824820
- Sponsor's protocol ID
- 00001138
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Commercial Genital Vibrators Use on Female Wellness
- ClinicalTrials.gov ID
- NCT04824820
- Acronym / sponsor ID
- 00001138
- Conditions
- Sexuality, Sexual Dysfunction, Sexual Desire Disorder, Hypoactive Sexual Desire Disorder, Orgasmic Disorder, Pelvic Organ Prolapse
- Keywords
- sexuality, Sexual Dysfunction, Sexual Desire Disorder, Hypoactive Sexual Desire Disorder, Orgasmic Disorder, Pelvic Organ Prolapse, Urinary Incontinence, Interstitial Cystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrator | Experimental | Behavioral: VibratorParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Non English speaking
- Pregnancy or <12 months postpartum
- Poor manual dexterity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibratorClitoral stimulation | Behavioural | Vibrator |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karyn Eilber, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrator in people with Sexuality and Sexual Dysfunction, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the change from baseline sexual function at 3 month (time frame: baseline, post intervention at 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023; AzTrials last refreshed its copy on 27 Oct 2026.