Ethical review
This study was conducted in the spirit of the Declaration of Helsinki (Fortaleza Amendment, October 2013) and in compliance with the “Ethical Guidelines for Medical and Health Research Involving Human Subjects (December 22, 2014, partially amended on February 28, 2017, Ministry of Education, Culture, Sports, Science and Technology and Ministry of Health, Labour and Welfare)” and the Protocol. Furthermore, this study was approved by the Clinical Trial Review Committee of Medical Corporation Association Ouryokukai Nihonbashi Sakura Clinic and registered at the University Hospital Medical Information Network Clinical Trials Registry before its implementation.
Study participants
The subjects of this study were Japanese women who met the inclusion criteria and did not meet the exclusion criteria. The inclusion criteria were as follows: (1) women between 20 and 49 years of age during consent, (2) subjects with a body mass index (BMI) of ≥18.5 kg/m2, (3) subjects with a body fat percentage between 20% and 35%, (4) subjects with a weight change of ≤10% between the weight during enrollment and that on the day of observation 1 month later, and (5) subjects have consented in writing to participate in this study The exclusion criteria were as follows: (1) subjects who were wearing supplementary (corrective) underwear, (2) subjects who had undergone breast reconstruction surgery, (3) subjects who have undergone breast augmentation surgery, (4) subjects who were taking contraceptive pills (regardless of dose), (5) subjects who were taking supplements for slimming or breast enhancement, (6) subjects who had undergone liposuction surgery, and (7) subjects with a history of surgery that would affect the evaluation of this study.
Adequate written and oral explanations were given to the subjects beforehand, and voluntary written informed consent was obtained from each subject.
Study design
This was a prospective observational study conducted at a single institution. Subjects were recruited via the Internet, and written informed consent was obtained. One month after consent was obtained, the subjects wore normal underwear without using any prosthetic underwear as the introduction period. The weight and other measurements of the subjects were measured on the observation day after the end of the introduction period, and those whose weight were within ±10% of their weight at the time of enrollment and on the observation day one month later began wearing corrective underwear. Those whose weight change exceeded ±10% were dropped out of the study. The values measured on the observation day were used as the baseline, and the period from the observation day one month later to the observation day eight months later was defined as the period of wearing the underwear, and the weight and other data were measured on the observation day eight month later.
In this study, a body fitter selected and provided prosthetic underwear according to the subject’s body shape. During the wearing period, the body fitter conducted fittings every two weeks to a month, checked the condition of the subjects’ breasts, and changed the underwear according to the subject’s conditions if necessary.
The prosthetic underwear used was the “Bradelis” series from Gold Flag Co. It was manufactured based on the “prosthetic underwear step system,” and the features of the prosthetic underwear at each step were as follows:
(1) Breasts
Stage 1: Use a bra with a wide wire contour to gather the underarm, back, and breast flesh into the correct position and create a border under the bust.
Stage 2: Use a bra with a narrower wire contour and more space in the bust to gather the flesh to the center and create cleavage from the border under the bust. Use a night bra at bedtime.
(2) Hips
Stage 1: Use a pair of shorts that are three-dimensionally cut with stretchy and breathable material to wrap around the hips from the waist to restore the roundness of the buttocks.
Stage 2: Use a soft long girdle that can support and pull up from the thighs to the buttocks without constricting the groin area due to the material and three-dimensional cutting.
In addition, the same body fitter was available for all study subjects throughout the study. This person was familiar with the product and system, and was skilled in teaching them how to wear the product correctly, choose the correct size of underwear, and determine when to change from stage 1 to 2.
During the observation period, all study subjects were instructed not to diet or do muscle training, but to maintain the same frequency of diet and exercise as before the study began.
Evaluation items
The background of the study subjects was ascertained at the time of enrollment. Body weight and BMI were measured at the time of enrollment, on the observation day after 1 month, and on the observation day after 8 months. Body fat percentage was measured using the bioimpedance method at the aforementioned measurement periods. Body sizes, including the top breast, under breast, waist, and hips, and the distance between the nipples and the center of the clavicle, were measured at enrollment, on the observation day after 1 month, and on the observation day after 8 months.
The subjects were photographed using a 3D body scanner (Bodyline Scanner 3D Ligament Measurement System C9036, Hamamatsu Photonics KK, Shizuoka, Japan) on the observation days of 1 months and 8 months, respectively. The upper body was photographed without any clothes, and the lower body was photographed wearing only non-Bradelis panties.
The following items were obtained from the quality of life (QOL) questionnaire:
On the observation day after one month
Shoulder stiffness, dissatisfaction with underwear, expectations for corrective underwear, etc.
On the observation day after 1 and after 8 months, respectively
Comfort of bra, comfort of panties, degree of improvement in stiff shoulders, degree of improvement in dissatisfaction with underwear, and feeling of using corrective underwear
In addition, the wearing status of the corrective underwear was obtained.
Endpoints
The primary endpoint of this study is the changes in the area ratio of the back flesh as it moves to the chest, as measured by cross-sectional views using a 3D body scanner. For each subject, the value on the observation day after 8 months was compared with the baseline values on the observation day after 1 month. In the chest cross-sectional view, the ratio of the front to the back was divided into 2:8, and the area ratio was measured using the chest side as the chest circumference (2/10) and the back side as the chest girth (8/10).
The secondary endpoints were breast size, underbust size, distance from nipple and clavicle center, waist size, hip size, and QOL assessment, and the values at the 8-month observation day were compared to the baseline values at the 1-month observation date.
Statistical analysis
In the statistical analysis of this study, subjects whose percentage of change between the 1-month and 8-month observation dates of the breasts, using the 3D body scanner exceeded ±10% were excluded because of possible measurement inadequacies at the time of measurement.
For each endpoint, paired t-test was used to compare the values at the 1-month observation day with those at the 8-month observation day. For the primary endpoint, stratified analysis was performed by age and breastfeeding experience. For age, each groups was compared using analysis of variance, and Bonferroni’s multiple comparisons were performed when significant differences occurred. For breastfeeding experience, Student’s t-test was used to compare the groups. The significance level was two-sided and was set at 5%. R version 3.6.2 (R Core Team, Vienna, Austria) was used for statistical analysis.