Improving Female Sexual Wellness

Not Applicable

Completed

• Conditions: Sexual Desire Disorder; Orgasmic Disorder; Sexual Dysfunction; Pelvic Floor Disorders; Urinary Incontinence; Female Sexual Dysfunction; Hypoactive Sexual Desire Disorder; Pelvic Organ Prolapse; Sexuality; Interstitial Cystitis
• Interventions: Behavioral: Vibrator

• Registration Number: NCT04824820
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-04-10
• Primary Completion: 2023-01-01
• Status Verified: 2023-04
• Study Completion: 2023-04-05
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vibrator	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.

Primary Outcome Measures

Name	Time	Method
To assess the change from baseline overall health and quality of life at 3 month	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.
To assess the change from baseline sexual function at 3 month	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	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.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States