Actively Recruiting
Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
Led by Tampere University Hospital · Updated on 2025-03-20
1000
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
Tampere University Hospital
Lead Sponsor
T
Tampere University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how the loop electrosurgical excision procedure (LEEP) affects sexual function and quality of life in women with HPV-related cervical lesions. The study compares women undergoing LEEP to those who only have colposcopy visits, focusing on any changes in sexual function and health-related quality of life over time. The research is conducted across multiple centers and includes women referred for colposcopy due to cytological abnormalities or repeated HPV positivity. Participants are divided into two groups: one receiving the LEEP treatment, which removes the affected cervical area using a small electric loop under local anesthesia, and a control group undergoing only colposcopy without LEEP. The study follows women over several years, with assessments planned at the first visit, then at 6 months, 24 months, 3 years, and 5 years after the initial procedure or colposcopy. During the study, participants complete web-based questionnaires about their sexual function using the Female Sexual Function Index (FSFI) and health-related quality of life using the 15D questionnaire. Researchers also collect background information from patient files and questionnaires. No additional visits or sample collections are required. The main outcomes measured are self-reported sexual function and quality of life scores over the follow-up period, with data securely managed and stored for analysis.
CONDITIONS
Brief Title
Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- First colposcopy visit or no colposcopy in the past 24 months
- Referred 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
- Able to understand the study protocol and provide informed consent
- Fluent in Finnish
You will not qualify if you...
- Age less than 18 or more than 70 years
- Previous colposcopy within 24 months
- Referral for reasons other than cytological changes or HPV, such as 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 or no informed consent given
- Difficulties in understanding Finnish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the first colposcopy visit
Duration - 5 years
Participants complete questionnaires about sexual function and quality of life sent by mail or available online at multiple time points after their colposcopy or LEEP procedure. No additional clinic visits or samples are required.
5 contacts: at recruitment, 6 months, 24 months, 3 years, and 5 years after the initial visit
Trial Site Locations
Total: 5 locations
1
Helsinki University Central Hospital
Helsinki, Finland
Actively Recruiting
2
North Karelia Central Hospital
Joensuu, Finland
Actively Recruiting
3
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
4
Oulu University Hospital
Oulu, Finland
Actively Recruiting
5
Tampere University Hospital
Tampere, Finland
Actively Recruiting
Research Team
L
Laura Kotaniemi-Talonen, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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