NCT05900869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

20 days

First QC Date

May 30, 2023

Last Update Submit

June 4, 2024

Conditions

Plastic Surgery

Outcome Measures

Primary Outcomes (1)

  • Female Sexual Function Index (FSFI)

    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.

    Change from Baseline 3 yers after surgery

Secondary Outcomes (1)

  • Body Esteem Scale (BES)

    Change from Baseline 3 yers after surgery

Interventions

FSFIOTHER

Female Sexual Function Index questionnaire

BESOTHER

Body Esteem Scale questionnaire

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated on a reduction nymphoplasty, for uni or bilateral labia minora hypertrophy

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Interventions

BES

Study Officials

  • Jenifer SALERNO

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 13, 2023

Study Start

May 8, 2023

Primary Completion

May 28, 2023

Study Completion

September 14, 2023

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

FR(1)