Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
Recruiting now
Conditions studied: Cervical Dysplasia
In brief
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.
Key facts
- Study ID
- NCT06078514
- Run by
- Tampere University Hospital
- People needed
- 1000
- Starts
- 2024-05-02
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2025-03-20
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
- Not pregnant at the time of colposcopy/LEEP
- Sexually active
- Capable of understanding the study protocol - informed consent given
- Fluent in Finnish
You may not qualify if…
- 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
- Pregnant at the time of colposcopy/LEEP
- Sexually inactive
- Unable to understand the study protocol - no informed consent
- Difficulties in understanding Finnish
Where it is running
- Helsinki University Central Hospital — Helsinki, Finland (enrolling)
- North Karelia Central Hospital — Joensuu, Finland (enrolling)
- Kuopio University Hospital — Kuopio, Finland (enrolling)
- Oulu University Hospital — Oulu, Finland (enrolling)
- Tampere University Hospital — Tampere, Finland (enrolling)
Full record on ClinicalTrials.gov
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