Sexuality After Reduction Mammaplasty

Depression Clinical Trial

Official title:

Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020422
• Other study ID #: Dinter 02
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: September 2011

Study information

• Verified date: September 2019
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Sexual Function

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas Samuel Libânio - UNIVÁS	Pouso Alegre	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Daniela Francescato Veiga	Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Beraldo FN, Veiga DF, Veiga-Filho J, Garcia ES, Vilas-Bôas GS, Juliano Y, Sabino-Neto M, Ferreira LM. Sexual Function and Depression Outcomes Among Breast Hypertrophy Patients Undergoing Reduction Mammaplasty: A Randomized Controlled Trial. Ann Plast Surg — View Citation

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 He

Garcia ES, Veiga DF, Sabino-Neto M, Beraldo Cardoso FN, Batista IO, Leme RM, Cabral IV, Novo NF, Ferreira LM. Sensitivity of the Nipple-Areola Complex and Sexual Function Following Reduction Mammaplasty. Aesthet Surg J. 2015 Sep;35(7):NP193-202. doi: 10.1093/asj/sjv034. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual function	Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.	6 months
Secondary	depression predictors	Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.	6 months