Clinical trial NCT04796090: Genital Wart and Sexuality in Adolescence
Official title: Genital Warts is Related With Sexual Dysfunction and Sexual Distress in Adolescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Development
Genital Wart
Sexual Dysfunction
Sexual Disorder, Physiological
Keywords: Genital wart
Female sexual dysfunction
Late adolescence
Sexuality related distress
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The current study included 45 adolescents with the diagnosis of genital warts as the Study group and 45 healthy adolescents as the Control group.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Female Sexual Function Index
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Arizona Sexual Experiences Scale
timeFrame: Through study completion, an average of 6 months
measure: Female Sexual Distress Scale-Revised
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Esin Merve Erol Koç, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.