Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study

NCT06078514 | Recruiting

• 1 other identifier: R22017
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Cervical Dysplasia

Keywords

Colposcopy; LEEP; Cervical dysplasia; HSIL; Sexual function index; Health-related quality of life

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  From 6 months up to 5 years since the initiation of the study

Study Arms (2)

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

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

Interventions

Loop electrosurgical excision procedure (LEEP) PROCEDURE

The affected area of cervix is excised under local anesthesia using a small thin electrically charged hardwire loop for simultaneous cutting and electrocoagulation.

Also known as: Large loop excision of the transformation zone (LLETZ)

Loop electrosurgical excision procedure (LEEP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Female by birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• 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

Study Sites (5)

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

North Karelia Central Hospital

Joensuu, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Oulu University Hospital

Oulu, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Laura Kotaniemi-Talonen, PhD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Kotaniemi-Talonen, PhD

CONTACT

+358 3 311 66008; laura.kotaniemi-talonen@pirha.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief, Gynecology and Obstetrics

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 12, 2023
• Study Start: May 2, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (5)