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

Recruitingn/aAges 18 Years - 70 YearsFemaleTampere University Hospital
NCT06078514 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Loop electrosurgical excision procedure (LEEP)
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Where

5 sites
Helsinki University Central Hospital
Helsinki, Finland
North Karelia Central Hospital
Joensuu, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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