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OpenTrials
Completed

NCT Number: NCT04824820

Improving Female Sexual Wellness

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.

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Key information

Conditions

Sexuality Behavior Cystitis Cystitis, Interstitial Female Sexual Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Hypoactive Sexual Desire Disorder Interstitial Cystitis Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Orgasmic Disorder Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pelvic Organ Prolapse Pregnancy Complications Prolapse Sexual Behavior Sexual Desire Disorder Sexual Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urinary Bladder Diseases Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrator

Behavioral

Clitoral stimulation

Primary outcomes

  1. To assess the change from baseline sexual function at 3 month

    Time frame: baseline, post intervention at 3 months

    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).

  2. To assess the change from baseline sexual function at 3 month

    Time frame: 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.

  3. To assess the change from baseline degree of pelvic organ prolapse at 3 month

    Time frame: 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.

  4. To assess the change from baseline overall health and quality of life at 3 month

    Time frame: baseline, post intervention at 3 months

    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.

  5. To assess the change from baseline overall health and quality of life at 3 month

    Time frame: baseline, post intervention at 3 months

    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.

  6. To assess the change from baseline overall health and quality of life at 3 month

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Effect of Commercial Genital Vibrators Use on Female Wellness

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2021
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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