Improving Female Sexual Wellness

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04824820
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
24.9
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Commercial Genital Vibrators Use on Female Wellness
Actual Study Start Date :
Apr 10, 2021
Anticipated Primary Completion Date :
Feb 9, 2023
Anticipated Study Completion Date :
May 9, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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.

Behavioral: Vibrator
Clitoral stimulation

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cedars Sinai Medical CenterLos AngelesCaliforniaUnited States90048

Sponsors and Collaborators

  • Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Karyn Eilber, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karyn Eilber, Female Pelvic Medicine & Reconstructive Surgery Chair, Cedars-Sinai Medical Group Department of Surgery Associate Professor, Urology and Obstetrics & Gynecology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT04824820
Other Study ID Numbers:
  • 00001138
First Posted:
Apr 1, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karyn Eilber, Female Pelvic Medicine & Reconstructive Surgery Chair, Cedars-Sinai Medical Group Department of Surgery Associate Professor, Urology and Obstetrics & Gynecology, Cedars-Sinai Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022