Improving Female Sexual Wellness

Urinary Incontinence Clinical Trial

Official title:

Effect of Commercial Genital Vibrators Use on Female Wellness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824820
• Other study ID #: 00001138
• Status: Completed
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 5, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Disease
• Enuresis
• Female Sexual Dysfunction
• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Interstitial Cystitis
• Orgasmic Disorder
• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Prolapse
• Sexual Desire Disorder
• Sexual Dysfunction
• Sexual Dysfunctions, Psychological
• Sexuality
• Urinary Incontinence

Intervention

Behavioral:
• Vibrator
Clitoral stimulation

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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