Study comparing different surgical treatments for Labia Minora Hypertrophy

A prospective, randomized, comparative study on the treatment of Labia Minora Hypertrophy using CO2 Laser, Radiofrequency and Cold Scalpel

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-6g29z3j

Enrollment

Registered

2026-02-26

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophy

Interventions

This is a prospective, randomized, controlled, three arm parallel open label clinical trial involving a total of 73 participants diagnosed with labia minora hypertrophy, with approximately 24 particip

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Women; aged between 18 and 70 years; complaint of labia minora hypertrophy; medical indication for labiaplasty; agreement to participate in the study by signing the Informed Consent Form

Exclusion criteria

Exclusion criteria: Presence of untreated active genitourinary infection; known coagulation disorders; pregnancy or postpartum period; known allergy to the anesthetics used; abnormal genital bleeding; uncontrolled systemic comorbidities that may interfere with wound healing such as decompensated diabetes mellitus, malnutrition or vasculopathies; clinical contraindication for outpatient procedure

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of performing labiaplasty with Carbon Dioxide Laser and Radiofrequency in an outpatient setting, verified through recording of intraoperative and postoperative complications, measurement of estimated blood loss by gauze weighing, volume of local anesthetic used and total procedure time, with the absolute number and frequency of recorded complications observed during the six month follow up period	—

Measure

Time frame

To evaluate the safety of performing labiaplasty with Carbon Dioxide Laser and Radiofrequency in an outpatient setting, verified through recording of intraoperative and postoperative complications, measurement of estimated blood loss by gauze weighing, volume of local anesthetic used and total procedure time, with the absolute number and frequency of recorded complications observed during the six month follow up period

—

Secondary

Measure	Time frame
To evaluate intraoperative and postoperative pain intensity among the different surgical techniques, verified through application of the visual analogue pain scale preoperatively and at 7, 30, 90 and 180 days after the procedure, with mean scores and score variations observed between groups during the six month follow up period;To evaluate total operative time of the different surgical techniques, verified through measurement in minutes from the beginning to the end of the procedure, with mean times and differences observed between groups;To evaluate intraoperative blood loss among the different surgical techniques, verified through gauze weighing during the procedure, with estimated blood loss measured in grams and compared between groups;To evaluate aesthetic and functional satisfaction after labiaplasty, verified through application of the Female Genital Self Image Scale and the Female Sexual Function Index preoperatively and at 180 days, with score variations observed between evaluation periods	—

Measure

Time frame

To evaluate intraoperative and postoperative pain intensity among the different surgical techniques, verified through application of the visual analogue pain scale preoperatively and at 7, 30, 90 and 180 days after the procedure, with mean scores and score variations observed between groups during the six month follow up period;To evaluate total operative time of the different surgical techniques, verified through measurement in minutes from the beginning to the end of the procedure, with mean times and differences observed between groups;To evaluate intraoperative blood loss among the different surgical techniques, verified through gauze weighing during the procedure, with estimated blood loss measured in grams and compared between groups;To evaluate aesthetic and functional satisfaction after labiaplasty, verified through application of the Female Genital Self Image Scale and the Female Sexual Function Index preoperatively and at 180 days, with score variations observed between evaluation periods

—

Countries

Brazil

Contacts

Public ContactLarissa Rabello

Escola Paulista de Medicina da Universidade Federal de São Paulo

larissa.macedo@unifesp.br+55 11 3385-4343

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026