Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
ConditionCervical Dysplasia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorTampere University Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Loop electrosurgical excision procedure (LEEP)
Procedure/SurgeryThe affected area of cervix is excised under local anesthesia using a small thin electrically charged hardwire loop for simultaneous cutting and electrocoagulation.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Loop electrosurgical excision procedure (LEEP)1 intervention
Group B: Colposcopy only0 interventions
Trial outcomes
Primary outcomes
1
Self-reported sexual function measured by Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI) is a 19-item self-report measure that provides scores on overall levels of sexual function as well as the primary components of sexual function in women, including sexual desire, arousal, orgasm, pain, and satisfaction. For scoring it uses a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning on the respective item. Total that scores of ≤26.55 are considered to present clinically relevant sexual dysfunction (specificity = 0.733; sensitivity = 0.889).
Time frame
From 6 months up to 5 years since the initiation of the study2
Self-reported health-related quality of life measured by 15D
15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL). It includes the following 15 dimensions: breathing, mental function, speech (communication), vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression. The maximum score is 1 (no problems on any dimension) and the minimum score is 0. A change of 0.02-0.03 has been observed to be such that people can feel the difference.
Time frame
From 6 months up to 5 years since the initiation of the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
University of Helsinki
Collaborator
Kuopio University Hospital
Collaborator
Oulu University Hospital
Collaborator
Hyvinkää Hospital
Collaborator
North Karelia Central Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov