Genital Wart and Sexuality in Adolescence

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Completed

CT.gov ID

NCT04796090

Collaborator

(none)

Enrollment

Location

6.5

Actual Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Development Genital Wart Sexual Dysfunction Sexual Disorder, Physiological	Other: Clinical assessment

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.

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Genital Warts is Related With Sexual Dysfunction and Sexual Distress in Adolescence

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Feb 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Adolescents with genital warts (Study Group) The Study group included adolescents who was diagnosed as positive for genital warts during the examination.	Other: Clinical assessment 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.	Other: Clinical assessment FSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts.

Arm

Intervention/Treatment

Adolescents with genital warts (Study Group)

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

Other: Clinical assessment

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.

Other: Clinical assessment

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

Outcome Measures

Primary Outcome Measures

Female Sexual Function Index [Through study completion, an average of 6 months]
Questionnaire score with minimum and maximum levels of 2.4 and 36 points,respectively. Higher scores mean a better outcome.

Secondary Outcome Measures

Arizona Sexual Experiences Scale [Through study completion, an average of 6 months]
Questionnaire score with minimum and maximum levels of 5 and 30 points,respectively. Higher scores mean a worse outcome.
Female Sexual Distress Scale-Revised [Through study completion, an average of 6 months]
Questionnaire score with minimum and maximum levels of 0 and 50 points,respectively. Higher scores mean a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 21 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.