Improving Female Sexual Wellness

NCT ID: NCT04824820

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-10

Study Completion Date

2023-04-05

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vibrator

Intervention Type BEHAVIORAL

Clitoral stimulation

Interventions

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Vibrator

Clitoral stimulation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Karyn Eilber

Female Pelvic Medicine & Reconstructive Surgery Chair, Cedars-Sinai Medical Group Department of Surgery Associate Professor, Urology and Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karyn Eilber, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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00001138

Identifier Type: -

Identifier Source: org_study_id

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