Clinical Trial

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

Study acronym: SEQUEL
Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-10-05; most recent amendment 2025-03-19.
Status change: Not Yet Recruiting → Recruiting 2024-11-14
Trial Details
NCT Number NCT06078514
Lead Sponsor Tampere University Hospital
Collaborators: Tampere University, University of Helsinki, Kuopio University Hospital, Oulu University Hospital, Hyvinkää Hospital, North Karelia Central Hospital, Helsinki University Central Hospital
Conditions Cervical Dysplasia
Enrollment 1,000 participants
Start Date 2024-05-02
Primary Completion 2028-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-20