Sexuality After Reduction Mammaplasty

Not Applicable

Completed

• Conditions: Sexual Function; Depression
• Interventions: Procedure: Reduction mammaplasty

• Registration Number: NCT01020422
• Lead Sponsor: Daniela Francescato Veiga

Brief Summary

The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.

Detailed Description

Breast hypertrophy is a common condition among women. Reduction mammaplasty is an effective and well established procedure performed for the relief discomfort associated with breast hypertrophy. Female breasts play an important role in sexuality, thus, the main purpose of this study is to determine whether reduction mammaplasty could influence sexual function and depression predictors on women with breast hypertrophy.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-11
• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-25
• Study Completion: 2011-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• breast hypertrophy
• candidate to reduction mammaplasty
• healthy volunteer with normal volume breasts (control group)
• body mass index under 30Kg/m2

Exclusion Criteria

• pregnancy, delivery or breast feeding during the last 12 months
• body mass index over 30Kg/m2
• breast cancer history
• previous breast surgery
• hard smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduction Mammaplasty	Reduction mammaplasty	Breast hypertrophy patients randomized to this group will immediately be scheduled for reduction mammaplasty and will be will be evaluated in regard to sexual function and depression predictors preoperatively and 3 and 6 months postoperatively

Primary Outcome Measures

Name	Time	Method
Sexual function	6 months	Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.

Secondary Outcome Measures

Name	Time	Method
depression predictors	6 months	Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.

Trial Locations

Locations (1)

Hospital das Clínicas Samuel Libânio - UNIVÁS; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil