Clinical trial NCT06078514: Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
Official title: Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Dysplasia
Keywords: Colposcopy
LEEP
Cervical dysplasia
HSIL
Sexual function index
Health-related quality of life
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: University of Helsinki
name: Kuopio University Hospital
name: Oulu University Hospital
name: Hyvinkää Hospital
name: North Karelia Central Hospital
name: Helsinki University Central Hospital
First posted: 2023-10-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult, sexually active, non-pregnant, 18-70 year-old women referred to gynecology outpatient clinics of the participating units for colposcopy due to cytological changes or repeated HPV positivity.

Brief 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.

Detailed description: We plan to recruit minimum of 1000 women referred to colposcopy in Tampere University Hospital, Helsinki University Hospital, Kuopio University Hospital, Oulu University Hospital, North Karelia Central Hospital and Hyvinkää Hospital to our prospective multi-center study. Recruitment is done at gynecology outpatient clinics of the participating units at the first colposcopy visit, where the doctor performing the colposcopy informs the eligible women about the study, gives them the patient information letter, and asks them to participate and, if they agree, to fill in the informed consent. We aim to recruit 500 women undergoing LEEP (intervention arm) and at least 500 undergoing only colposcopy (control arm).

Pirkanmaa Hospital District Ethical Review Board has approved the study design and local scientific committees in each university hospital area applied for permission to launch the study.

In each participating unit, eligible women will be given a written patient information sheet on the study and asked to participate. From women willing to participate, a written informed consent will be collected and stored in locked cabinet in participating unit. These documents will be accessed only by study members.

Participants are contacted due to the study 5 times: at the time of recruitment, 6 months after the index visit (either first colposcopy or LEEP visit) and 24 months, 3 years and 5 years after the index visit. Each time they are asked to fill in the same questionnaires, sent by mail and available also web based. No additional visits are needed, nor any extra samples taken.

The study data is collected using REDCap system designed for safe patient data management. Access to the system is strictly restricted to the research team members, that are committed to handle the data according to good clinical practice.

At the end of the study, the digital data is to be stored at Pirkanmaa Hospital Disctrict official research files, where individual patient data will be available only for identified study members. In the analysis the data will be used pseudonymized. Informed consents will be stored in participating research units.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Age less than 18 or more than 70 years
* Previous colposcopy within 24 months
* Referral for other reason, e.g. 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 - no informed consent
* Difficulties in understanding Finnish

Primary outcomes:
measure: Self-reported sexual function measured by Female Sexual Function Index (FSFI)
timeFrame: From 6 months up to 5 years since the initiation of the study
measure: Self-reported health-related quality of life measured by 15D
timeFrame: From 6 months up to 5 years since the initiation of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Joensuu
country: Finland
facility: North Karelia Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Laura Kotaniemi-Talonen, PhD
role: PRINCIPAL_INVESTIGATOR
References: