NCT06078514 Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
| NCT ID | NCT06078514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University Hospital |
| Condition | Cervical Dysplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-05-02 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-05-02 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Laura Kotaniemi-Talonen, PhD
PRINCIPAL INVESTIGATOR
Tampere University Hospital
Frequently Asked Questions
Who can join the NCT06078514 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Cervical Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06078514 currently recruiting?
Yes, NCT06078514 is actively recruiting participants. Contact the research team at laura.kotaniemi-talonen@pirha.fi for enrollment information.
Where is the NCT06078514 trial being conducted?
This trial is being conducted at Helsinki, Finland, Joensuu, Finland, Kuopio, Finland, Oulu, Finland and 1 additional location.
Who is sponsoring the NCT06078514 clinical trial?
NCT06078514 is sponsored by Tampere University Hospital. The principal investigator is Laura Kotaniemi-Talonen, PhD at Tampere University Hospital. The trial plans to enroll 1,000 participants.