Cervical DysplasiaSEQUELNCT06078514
Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
An observational study of Cervical Dysplasia, run by Tampere University Hospital at 5 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- Loop electrosurgical excision procedure (LEEP)
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 5 sitesFinland
- Study dates
- 2 May 2024to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Finland5 sites, 5 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Annu Heinonen, PhD
- Recruiting
North Karelia Central Hospital
Joensuu
Ulla Korhonen, PhD
- Recruiting
Kuopio University Hospital
Kuopio
Johanna Palmroth, PhD
- Recruiting
Oulu University Hospital
Oulu
Marja Simojoki, PhD
- Recruiting
Tampere University Hospital
Tampere
Laura Kotaniemi-Talonen, Ass. prof, laura.kotaniemi-talonen@tuni.fi
Karolina Louvanto, Prof, karolina.louvanto@tuni.fi
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Cervical Dysplasia
- Being tested
- Loop electrosurgical excision procedure (LEEP)
- Keywords
- Colposcopy, LEEP, Cervical dysplasia, HSIL, Sexual function index, Health-related quality of life
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop electrosurgical excision procedure (LEEP)Procedure or surgery
Also called Large loop excision of the transformation zone (LLETZ)
The affected area of cervix is excised under local anesthesia using a small thin electrically charged hardwire loop for simultaneous cutting and electrocoagulation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Loop electrosurgical excision procedure (LEEP) | |
| Colposcopy only | Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity with no indication to LEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From 6 months up to 5 years since the initiation of the study
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.
Measured: From 6 months up to 5 years since the initiation of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start2 May 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DysplasiaStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Helsinki, Kuopio University Hospital, Oulu University Hospital, Hyvinkää Hospital, North Karelia Central Hospital, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Laura Kotaniemi-Talonen, Tampere University Hospital
- Investigators
- Laura Kotaniemi-Talonen, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078514
- Sponsor's protocol ID
- R22017
- Acronym
- SEQUEL
- Status last verified
- Mar 2025
- First submitted
- 5 Oct 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
- ClinicalTrials.gov ID
- NCT06078514
- Acronym / sponsor ID
- SEQUEL / R22017
- Conditions
- Cervical Dysplasia
- Keywords
- Colposcopy, LEEP, Cervical dysplasia, HSIL, Sexual function index, Health-related quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Helsinki, Kuopio University Hospital, Oulu University Hospital, Hyvinkää Hospital, North Karelia Central Hospital, Helsinki University Central Hospital
- Study start
- 2 May 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loop electrosurgical excision procedure (LEEP) | – | Procedure: 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loop electrosurgical excision procedure (LEEP)Also: Large loop excision of the transformation zone (LLETZ)The affected area of cervix is excised under local anesthesia using a small thin electrically charged hardwire loop for simultaneous cutting and electrocoagulation. | Procedure or surgery | Loop electrosurgical excision procedure (LEEP) |
Primary outcome
Self-reported sexual function measured by Female Sexual Function Index (FSFI)
Time frame: From 6 months up to 5 years since the initiation of the study
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).
Self-reported health-related quality of life measured by 15D
Time frame: From 6 months up to 5 years since the initiation of the study
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Cervical Dysplasia
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Kotaniemi-Talonen, PhD principal investigator
Tampere University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dysplasia, run by Tampere University Hospital at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Kotaniemi-Talonen, PhD (+358 3 311 66008, laura.kotaniemi-talonen@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported sexual function measured by Female Sexual Function Index (FSFI) (time frame: From 6 months up to 5 years since the initiation of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.