Clinical trial · Observational
Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Loop electrosurgical excision procedure (LEEP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Loop electrosurgical excision procedure (LEEP)
- description
- Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity and undergone a LEEP procedure due to HPV-related cervical lesion
- interventionNames
- Procedure: Loop electrosurgical excision procedure (LEEP)
- label
- Colposcopy only
- description
- Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity with no indication to LEEP
Primary outcomes (2)
- 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
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
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