Impact of LEEP on Women's Sexual Function and Quality of Life

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.