Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04824820
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2021-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Female Sexual Wellness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D018856', 'term': 'Cystitis, Interstitial'}, {'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509515', 'term': 'Vib protein, Drosophila'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the change from baseline sexual function at 3 month', 'timeFrame': 'baseline, post intervention at 3 months', 'description': '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).'}, {'measure': 'To assess the change from baseline sexual function at 3 month', 'timeFrame': 'baseline, post intervention at 3 months', 'description': '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.'}, {'measure': 'To assess the change from baseline degree of pelvic organ prolapse at 3 month', 'timeFrame': 'baseline, post intervention at 3 months', 'description': '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.'}, {'measure': 'To assess the change from baseline overall health and quality of life at 3 month', 'timeFrame': 'baseline, post intervention at 3 months', 'description': "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."}, {'measure': 'To assess the change from baseline overall health and quality of life at 3 month', 'timeFrame': 'baseline, post intervention at 3 months', 'description': '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.'}, {'measure': 'To assess the change from baseline overall health and quality of life at 3 month', 'timeFrame': 'baseline, post intervention at 3 months', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], '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']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking\n* 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)\n* Manual dexterity to use vibrator\n\nExclusion Criteria:\n\n* Non English speaking\n* Pregnancy or \\<12 months postpartum\n* Poor manual dexterity'}, 'identificationModule': {'nctId': 'NCT04824820', 'briefTitle': 'Improving Female Sexual Wellness', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Effect of Commercial Genital Vibrators Use on Female Wellness', 'orgStudyIdInfo': {'id': '00001138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vibrator', 'description': '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.', 'interventionNames': ['Behavioral: Vibrator']}], 'interventions': [{'name': 'Vibrator', 'type': 'BEHAVIORAL', 'description': 'Clitoral stimulation', 'armGroupLabels': ['Vibrator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Karyn Eilber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Female Pelvic Medicine & Reconstructive Surgery Chair, Cedars-Sinai Medical Group Department of Surgery Associate Professor, Urology and Obstetrics & Gynecology', 'investigatorFullName': 'Karyn Eilber', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}