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RECRUITING
NCT06078514

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

Sponsor: Tampere University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2024-05-02

Completion Date

2030-12

Last Updated

2025-03-20

Healthy Volunteers

Yes

Interventions

PROCEDURE

Loop electrosurgical excision procedure (LEEP)

The affected area of cervix is excised under local anesthesia using a small thin electrically charged hardwire loop for simultaneous cutting and electrocoagulation.

Locations (5)

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