Impact of LEEP on Women's Sexual Function and Quality of Life
Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
This study is testing how the loop electrosurgical excision procedure (LEEP) affects sexual function and quality of life in women with HPV-related cervical lesions compared to those who only have a colposcopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 5 sites (Helsinki and 4 other locations) |
| Trial ID | NCT06078514 on ClinicalTrials.gov |
What this trial studies
This prospective multi-center study aims to evaluate the effects of the loop electrosurgical excision procedure (LEEP) on sexual function and quality of life in women with HPV-related cervical lesions. Participants will complete validated questionnaires, including the Female Sexual Function Index (FSFI) and the 15D quality of life questionnaire, at multiple time points: during their first colposcopy visit and at 6 months, 24 months, 3 years, and 5 years post-procedure. The study will compare outcomes between women undergoing LEEP and those receiving only colposcopy. A minimum of 1000 women will be recruited from several university hospitals in Finland.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 70 who are sexually active and undergoing their first colposcopy visit for HPV-related cervical lesions.
Not a fit: Patients who are not sexually active, pregnant, or have had previous cervical surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how LEEP affects sexual function and quality of life, guiding treatment decisions for women with cervical dysplasia.
How similar studies have performed: While this study's specific focus is novel, previous studies have explored related outcomes in cervical procedures, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki and 4 other locations
- Helsinki University Central Hospital — Helsinki, Finland (Recruiting)
- North Karelia Central Hospital — Joensuu, Finland (Recruiting)
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
- Oulu University Hospital — Oulu, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Principal investigator: Laura Kotaniemi-Talonen, PhD — Tampere University Hospital
- Study coordinator: Laura Kotaniemi-Talonen, PhD
- Email: laura.kotaniemi-talonen@pirha.fi
- Phone: +358 3 311 66008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.