About this trial
The goal of this prospective study is to investigate the sexual function and quality of life of women undergoing loop electrosurgical excision procedure (LEEP) due to HPV-related cervical lesion.
The main question it aims to answer are:
* Whether LEEP affects the sexual function of women in comparison to untreated women, and * Whether LEEP affects the health-related quality of life of women in comparison to untreated women
Participants are asked to complete web based an international validated self-report questionnaire on sexual function issues, the Female Sexual Function Index (FSFI), and a validated quality of life -questionnaire 15D at the time of first colposcopy appointment and six and 24 months, 3 years and 5 years after index visit (LEEP or first colposcopy in control group). Relevant additional background information is also collected via questionnaire and from patient files.
Researchers will compare women with LEEP and those with only colposcopy visits to see any differences between self-reported sexual function (FSFI scores) or health-related quality of life (15D scores) both short and long-term.
Eligibility criteria
Qualifiers
Age 18 to 70 years
First colposcopy visit (in 24 months, if previous colposcopies)
Referral for cytological changes or repeated HPV positivity
No previous LEEP or other operations affecting the length of cervix
Disqualifiers
Age less than 18 or more than 70 years
Previous colposcopy within 24 months
Referral for other reason, e.g. vulvar lesion
Previous LEEP or other operation affecting the length of cervix
Trial design
Treatments tested in this trial
- Loop electrosurgical excision procedure (LEEP)
Treatment groups
Sponsors and collaborators
Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
University of Helsinki
Collaborator
Kuopio University Hospital
Collaborator
Oulu University Hospital
Collaborator
Hyvinkää Hospital
Collaborator
North Karelia Central Hospital
Collaborator
Helsinki University Central Hospital
Collaborator