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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04824820
Other study ID # 00001138
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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