Sexuality After Reduction Mammaplasty
Primary Purpose
Sexual Function, Depression
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Reduction mammaplasty
Sponsored by
About this trial
This is an interventional health services research trial for Sexual Function focused on measuring breast hypertrophy, mammaplasty, sexuality, depression
Eligibility 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
Sites / Locations
- Hospital das Clínicas Samuel Libânio - UNIVÁS
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Breast hypertrophy
Reduction Mammaplasty
Arm Description
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
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
Outcomes
Primary Outcome Measures
Sexual function
Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.
Secondary Outcome Measures
depression predictors
Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.
Full Information
NCT ID
NCT01020422
First Posted
November 20, 2009
Last Updated
September 3, 2019
Sponsor
Daniela Francescato Veiga
Collaborators
Universidade do Vale do Sapucai
1. Study Identification
Unique Protocol Identification Number
NCT01020422
Brief Title
Sexuality After Reduction Mammaplasty
Official Title
Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Francescato Veiga
Collaborators
Universidade do Vale do Sapucai
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Function, Depression
Keywords
breast hypertrophy, mammaplasty, sexuality, depression
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast hypertrophy
Arm Type
No Intervention
Arm Description
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
Arm Title
Reduction Mammaplasty
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Reduction mammaplasty
Other Intervention Name(s)
Breast reduction
Intervention Description
Sexual function of patients undergoing reduction mammaplasty will be assessed by the Female Sexual Function Index (FSFI) preoperatively and 3 and 6 months postoperatively.
Primary Outcome Measure Information:
Title
Sexual function
Description
Sexual function will be assessed by the Female Sexual Function Index (FSFI), pre and 6 months postoperatively.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
depression predictors
Description
Depression predictors will me assessed by the Beck Depression Inventory (BDI) pre- and 6 months postoperatively.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia N Beraldo, PhD
Organizational Affiliation
UNIFESP and UNIVAS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniela F Veiga, MD, PhD
Organizational Affiliation
UNIFESP and UNIVAS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lydia M Ferreira, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas Samuel Libânio - UNIVÁS
City
Pouso Alegre
State/Province
Minas Gerais
ZIP/Postal Code
37550000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26319082
Citation
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.
Results Reference
background
PubMed Identifier
25536204
Citation
Beraldo FN, Veiga DF, Veiga-Filho J, Garcia ES, Vilas-Boas 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. 2016 Apr;76(4):379-82. doi: 10.1097/SAP.0000000000000380.
Results Reference
result
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Sexuality After Reduction Mammaplasty
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