Sexuality After Reduction Mammaplasty

This study has been completed.
Sponsor:
Collaborator:
Universidade do Vale do Sapucai
Information provided by (Responsible Party):
Daniela Francescato Veiga, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01020422
First received: November 20, 2009
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Sexual Function
Depression
Procedure: Reduction mammaplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Sexual function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.


Secondary Outcome Measures:
  • depression predictors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.


Enrollment: 60
Study Start Date: July 2008
Study Completion Date: September 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Breast hypertrophy
Patients with macromastia will be evaluated in regard to sexual function and depression predictors at 3 moments: initial interview, after 3 months and after 6 months
Experimental: 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
Procedure: Reduction mammaplasty
Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
Other Name: Breast reduction

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020422

Locations
Brazil
Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, Brazil, 37550000
Sponsors and Collaborators
Daniela Francescato Veiga
Universidade do Vale do Sapucai
Investigators
Principal Investigator: Flavia N Beraldo, MSC UNIFESP and UNIVAS
Study Director: Daniela F Veiga, MD, PhD UNIFESP and UNIVAS
Study Chair: Lydia M Ferreira, MD, PhD Federal University of São Paulo
  More Information

Publications:
Beraldo FN, Veiga DF, Veiga-Filho J,Vilas-Boas GS, Sabino-Neto M, Garcia EB, Juliano Y,Ferreira LM. Sexual function and depression outcomes in breast hypertrophy patients undergoing reduction mammaplasty: A randomized clinical trial. Journal of Women's Health 21(4):30, 2012. DOI: 10.1089/jwh.2012.Ab01

Responsible Party: Daniela Francescato Veiga, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01020422     History of Changes
Other Study ID Numbers: Dinter 02
Study First Received: November 20, 2009
Last Updated: March 5, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
breast hypertrophy
mammaplasty
sexuality
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014