Genital Wart and Sexuality in Adolescence

NCT ID: NCT04796090

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-02-15

Brief Summary

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The adolescence is a landmark in perceiving the sexuality and awareness about the sexual experiences. Genitals warts were shown to be a potential risk to impair the sexual functions in women. Adolescence is a vulnerable period in which the individuals may be prone to the negative effects of the disorders affecting sexual functions such as genital warts. The current study aimed to investigate the impact of genital warts on sexual functions in female adolescents.

Detailed Description

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This current study aimed to elucidate the impact of genital warts on female sexual function in adolescence. The current study also targeted to reveal whether there is any correlation between the genital warts and the female sexual dysfunction, as well as the sexuality related distress. The current study is conducted at Youth Center Outpatient Clinic of Ankara City Hospital which is a high-volume tertiary health care center in Turkey. The study was prospectively designed and data were collected between the 1 August 2020 and 1 February 2021. Totally 90 female adolescents between the age of 17-21 who had regular sexual intercourse with heterosexual partners were included. The Study group composed of 45 adolescents who had genital warts and the Control group included 45 healthy adolescents. Female sexual function Index (FSFI), Arizona Sexual Experiences Scale (ASEX) and Female Sexual Dysfunction Scale (FSDS) scores were compared between the two groups to evaluate the sexual functions. Difference between two independent means (two groups) power analysis demonstrated that this study achieved a power of 0.99, 0.98 , 0.99 with a 5% level of significance for comparison of 45 adolescents with genital warts and 45 healthy adolescents in terms of FSFI, ASEX, and FSDS scores, respectively.

Conditions

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Adolescent Development Genital Wart Sexual Dysfunction Sexual Disorder, Physiological

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Adolescents with genital warts (Study Group)

The Study group included adolescents who was diagnosed as positive for genital warts during the examination.

Clinical assessment

Intervention Type OTHER

FSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts.

Healthy adolescents (Control Group)

The Control group was composed of healthy adolescents who admitted for only contraceptive counselling.

Clinical assessment

Intervention Type OTHER

FSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts.

Interventions

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Clinical assessment

FSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The Study group included adolescents who was diagnosed as positive for genital warts during the examination.
* The Control group was composed of healthy adolescents who admitted for contraceptive counselling.

Exclusion Criteria

* Chronical disease including rheumatological diseases, renal failure, diabetes mellitus, hypertension, dyslipidemia, obesity, thyroid dysfunction, cardiopulmonary diseases, malignancy, cerebrovascular diseases, psychiatric and mental disorders, cerebrovascular diseases, inflammatory bowel diseases.
* Drug administration which may interfere sexual function.
* Surgical intervention to genital organs.
* History of pregnancy, delivery, and/or breastfeeding.
Minimum Eligible Age

17 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Esin Merve Erol Koç

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esin Merve Erol Koç, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Graziottin A, Serafini A. HPV infection in women: psychosexual impact of genital warts and intraepithelial lesions. J Sex Med. 2009 Mar;6(3):633-45. doi: 10.1111/j.1743-6109.2008.01151.x. Epub 2009 Jan 13.

Reference Type RESULT
PMID: 19170869 (View on PubMed)

McCabe MP, Sharlip ID, Atalla E, Balon R, Fisher AD, Laumann E, Lee SW, Lewis R, Segraves RT. Definitions of Sexual Dysfunctions in Women and Men: A Consensus Statement From the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):135-43. doi: 10.1016/j.jsxm.2015.12.019.

Reference Type RESULT
PMID: 26953828 (View on PubMed)

McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM, Manber R. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000 Jan-Mar;26(1):25-40. doi: 10.1080/009262300278623.

Reference Type RESULT
PMID: 10693114 (View on PubMed)

Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

Reference Type RESULT
PMID: 10782451 (View on PubMed)

Greydanus DE, Matytsina L. Female sexual dysfunction and adolescents. Curr Opin Obstet Gynecol. 2010 Oct;22(5):375-80. doi: 10.1097/GCO.0b013e32833d9418.

Reference Type RESULT
PMID: 20706119 (View on PubMed)

Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.

Reference Type RESULT
PMID: 18042215 (View on PubMed)

O'Sullivan LF, Byers ES, Brotto LA, Majerovich JA, Fletcher J. A Longitudinal Study of Problems in Sexual Functioning and Related Sexual Distress Among Middle to Late Adolescents. J Adolesc Health. 2016 Sep;59(3):318-324. doi: 10.1016/j.jadohealth.2016.05.001. Epub 2016 Jun 16.

Reference Type RESULT
PMID: 27320034 (View on PubMed)

Other Identifiers

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E1-20-1000

Identifier Type: -

Identifier Source: org_study_id

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