The Human Papilloma Virus Effect on Sexual Life

NCT03837028 | Completed Results

• 1 other identifier: BakirkoyDr.SadiKonuk
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases and its link with malignancies is well established, especially with anogenital tract cancers (cervical, vaginal, vulvar, anal cancers). HPV 16 and 18 are the most commonly isolated HPV types in cervical cancer, however not all infections with HPV 16 or 18 progress to cancer. After the HPV test has been used in cervical cancer screening, there have been concerns about whether women carry this virus. Although HPV testing may cause negative emotional responses, adverse emotional responses are related to HPV infection rather than testing. In this respect, there were several studies which evaluated the quality of life and psychological responses of women with positive HPV test results and it is known that positive HPV test results cause additional anxiety, distress and negative emotional responses in women. We hypothesized that the awareness of having a sexually transmitted infection in women with HPV and, therefore, a close follow-up and the need for further investigation such as colposcopy can affect their sexual life. In this study, we aimed to observe the changes in sexual function and anxiety of the HPV positive women with validated objective tools after being informed about their co-test results.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI) Score

  This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.

  change from initial overall FSFI score at second months.

Secondary Outcomes (1)

• Beck Anxiety Inventory (BAI) Score

  change from initial BAI score at second months.

Study Arms (4)

HPV 16/18 (+), cytology normal

Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.

Other: FSFI

HPV 16/18 (+), cytology abnormal

Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.

Other: FSFI

non-16/18 HPV (+), cytology abnormal

Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.

Other: FSFI

non-16/18 HPV (+), cytology normal

Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.

Other: FSFI

Interventions

FSFI OTHER

Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.

Also known as: Female Sexual Function Index Questionnaire

HPV 16/18 (+), cytology abnormal; HPV 16/18 (+), cytology normal; non-16/18 HPV (+), cytology abnormal; non-16/18 HPV (+), cytology normal

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women who were attended to our gynecology outpatient clinic due to HPV positivity according to the cervical cancer screening programme were recruited in this study.

You may qualify if:

• women aged between 30 and 50 years
• sexually active women
• women who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82)

You may not qualify if:

• postmenopausal women (defined as those with at least 12 consecutive months of amenorrhea with no other medical cause and a follicle- stimulating hormone (FSH) level of 40)
• women with chronic disease
• patients with antidepressant usage or patients with psychiatric disorders
• women who did not agree to participate in the study after reading the informed consent form
• women who admitted for follow up due to prior HPV infection
• women with only low-risk HPV (HPV 6, 11) positivity
• women with a sexual abuse history
• women with sexual penetration disorder

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ismail Alay
• Organization: bakirkoy dr sadi konuk training and research hospital

dr_ismailalay@hotmail.com

+905462375638

Study Officials

• Ismail Alay

  University Of Health Sciences Bakirkoy Sadi Konuk Training And Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 11, 2019
• Study Start: January 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 6, 2020
• Results First Posted: September 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)