Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorTampere University Hospital

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

1,000 Participants
are divided into 2 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