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OpenTrials
Completed

NCT Number: NCT05900869

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FSFI

Other

Female Sexual Function Index questionnaire

BES

Other

Body Esteem Scale questionnaire

Primary outcomes

  1. Female Sexual Function Index (FSFI)

    Time frame: 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 outcomes

  1. Body Esteem Scale (BES)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: NYRESED

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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