N/A
N=127
The Human Papilloma Virus Effect on Sexual Life
Human Papillomavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT03837028 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Female Sexual Function Index (FSFI) Score — 0.8; 1.2; 0.9; 0.7 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- FSFI (Other)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Female Sexual Function Index (FSFI) Score |
0.8; 1.2; 0.9; 0.7 | — |
| SECONDARY Beck Anxiety Inventory (BAI) Score |
4.5; 4.8; 4.1; 2.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03837028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.