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
343 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
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
Official 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 within 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 or LEEP
- Sexually active
- Able to understand the study 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 positivity (e.g., vulvar lesion)
- Previous LEEP or other surgery affecting cervix length
- Pregnant at the time of colposcopy or LEEP
- Sexually inactive
- Unable to understand the study protocol or no informed consent given
- Difficulty understanding Finnish language
AI-Screening
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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
CONTACT
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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