Reduction Nymphoplasty: Assessment of the Impact on Sexuality, Self-Esteem and Screening for Dysmorphophobia

Completed

• Conditions: Plastic Surgery

• Registration Number: NCT05900869
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Reduction nymphoplasty is the treatment of benign hyperplasia of the labia minora. This surgery is indicated in the event of functional, aesthetic or sexual discomfort. There has been a growing demand for this surgery over the past twenty years. It is necessary to remain vigilant because a request for cosmetic surgery can also be part of an obsession with body dysmorphism, former dysmorphophobia.

Investigators wish to study the postoperative results concerning sexuality, self-esteem and obsession with body dysmorphia in a cohort of patients followed prospectively and at more than 3 years postoperatively.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-08
• Primary Completion: 2023-05-28
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-13
• Study Completion: 2023-09-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

Patients informed of the objectives of the study and its progress,

Exclusion Criteria

Patients in a period of exclusion determined by another study. Patients under judicial safeguard, guardianship or curatorship. Patients for whom it is impossible to give informed information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI)	Change from Baseline 3 yers after surgery	Questionnaire on the evolution of sexuality. FSFI consists of 19 questions assessing 6 domains: sexual desire, arousal, lubrication, orgasm, sexual satisfaction and pain. It is based on the sexuality of the last 4 weeks. The questions report a score ranging from 0 or 1 to 5 and a different coefficient is assigned to each domain. The sum of these results constitutes the final score, between 2 and 32 with the threshold value defining an alteration of sexuality below 26.5/32.

Secondary Outcome Measures

Name	Time	Method
Body Esteem Scale (BES)	Change from Baseline 3 yers after surgery	Self-esteem questionnaire BES is composed of 23 questions, rated on a 5-point Likert scale (never, rarely, sometimes, often and always) and divided into 3 items corresponding to different dimensions of self-esteem: appearance, attribution and weight. The score is between 23 and 115, and the higher it is, the higher the body esteem and the appearance evaluated positively

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France