Improving Female Sexual Wellness

NCT04824820 | Completed

• 1 other identifier: 00001138
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

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.

Behavioral: Vibrator

Interventions

Vibrator BEHAVIORAL

Clitoral stimulation

Vibrator

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non English speaking
• Pregnancy or \<12 months postpartum
• Poor manual dexterity

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Sexuality; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Pelvic Organ Prolapse; Urinary Incontinence; Cystitis, Interstitial; Pelvic Floor Disorders

Interventions

Vib protein, Drosophila

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Genital Diseases; Urogenital Diseases; Mental Disorders; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Cystitis; Urinary Bladder Diseases; Pregnancy Complications

Study Officials

• Karyn Eilber, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Female Pelvic Medicine & Reconstructive Surgery Chair, Cedars-Sinai Medical Group Department of Surgery Associate Professor, Urology and Obstetrics & Gynecology

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: April 10, 2021
• Primary Completion: January 1, 2023
• Study Completion: April 5, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)