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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
North Karelia Central Hospital
RECRUITING
Joensuu
Kuopio University Hospital
RECRUITING
Kuopio
Oulu University Hospital
RECRUITING
Oulu
Tampere University Hospital
RECRUITING
Tampere
Contact Information
Primary
Laura Kotaniemi-Talonen, PhD
laura.kotaniemi-talonen@pirha.fi
+358 3 311 66008
Time Frame
Start Date: 2024-05-02
Estimated Completion Date: 2030-12
Participants
Target number of participants: 1000
Treatments
Loop electrosurgical excision procedure (LEEP)
Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity and undergone a LEEP procedure due to HPV-related cervical lesion
Colposcopy only
Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity with no indication to LEEP
Related Therapeutic Areas
Sponsors
Collaborators: Oulu University Hospital, University of Helsinki, Helsinki University Central Hospital, Hyvinkää Hospital, Tampere University, North Karelia Central Hospital, Kuopio University Hospital
Leads: Tampere University Hospital

This content was sourced from clinicaltrials.gov