Genital Wart and Sexuality in Adolescence

March 11, 2021 updated by: Esin Merve Erol Koç, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Female Sexual Function Index
Time Frame: 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.
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arizona Sexual Experiences Scale
Time Frame: 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.
Through study completion, an average of 6 months
Female Sexual Distress Scale-Revised
Time Frame: 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.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Esin Merve Erol Koç, MD, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-20-1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data belonging to participants only will be available to any researcher or editorial review board if needed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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