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

NCT06078514 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

  • Cervical Dysplasia

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.

Sponsors & Collaborators

  • Tampere University

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • Kuopio University Hospital

    collaborator OTHER

  • Oulu University Hospital

    collaborator OTHER

  • Hyvinkää Hospital

    collaborator OTHER

  • North Karelia Central Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Laura Kotaniemi-Talonen, PhD · Tampere University Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078514 on ClinicalTrials.gov