Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study (NCT06078514) | Clinical Trial Compass
RecruitingNot Applicable
Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
Finland1,000 participantsStarted 2024-05-02
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-reported sexual function measured by Female Sexual Function Index (FSFI)
Timeframe: From 6 months up to 5 years since the initiation of the study
2
Self-reported health-related quality of life measured by 15D
Timeframe: From 6 months up to 5 years since the initiation of the study