Dimensional Data on Vulva Vaginal Anatomy: Medical Device Design Barrier
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Proceedings of the 2020 Design of Medical Devices Conference DMD2020 April 6, 7-9, 2020, Minneapolis, MN, USA DMD2020-9025 Downloaded from http://asmedigitalcollection.asme.org/BIOMED/proceedings-pdf/DMD2020/83549/V001T08A002/6552698/v001t08a002-dmd2020-9025.pdf by guest on 24 September 2021 DIMENSIONAL DATA ON VULVA VAGINAL ANATOMY: MEDICAL DEVICE DESIGN BARRIER Avery Smith1 Ada-Rhodes Short2 Uccellini LLC Uccellini LLC Bend, OR, United States Bend, OR, United States ABSTRACT 1.1 Method An accurate understanding of anatomy allows designers We used EBSCO and Google Scholar as the databases and scientists to create medical devices that work well for their for surveying available studies on vulva vaginal dimensions market. However, reliable descriptions of vulva vaginal [1,2]. Search terms included: “vulva dimensions”, “vulva dimensions are not currently available for reference. This measurements”, “vaginal dimensions”, “vaginal measurements”, literature review attempts to survey the existing data collected “labia dimensions”, “labia measurements”, “clitoral on vulva vaginal dimensions and report the findings. We located dimensions”, “clitoral measurements”, and “vulva cross- scholarly journal articles and cross-sectional studies via sectional study”. When a potentially informative data set was not academic databases and online search engines. To pinpoint the published publicly, or not published in completeness online, a data that would be helpful in dimensional analysis of vulva request for distribution was submitted using an interlibrary loan vaginal measurements, key search terms included: “vulva program. All requests were approved, and the full texts were dimensions”, “vulva measurements”, “vaginal dimensions”, received. Papers and studies specifically looking at the genital “vaginal measurements”, “labia dimensions”, “labia anatomy of infants or fetuses, were not included. The relevant measurements”, “clitoral dimensions”, “clitoral documents were read, annotated, and cataloged in reference measurements”, and “vulva cross-sectional study”. management software [3]. Sample sizes, inclusion criteria, exclusion criteria, measurements, age range, race and ethnicity Keywords: Vulva vaginal, Medical devices, Designers, information are all metrics that were recorded and compared Dimensional Analysis, Anatomy, Survey. between each study in a spreadsheet. 1.2 Results INTRODUCTION The most extensive and best data set available surveyed In this study, we used academic databases and online search 657 white women aged 15-84 [4]. The data was broken up into engines to locate available studies on vulva vaginal decades, and measurements were tabulated for the 5th, 50th, and measurements. We anticipate there to be limited raw data 95th percentile of each decade. This data set is by far the best available for use by professionals interested in designing medical available resource due to its large sample size and the variety of devices interacting with female genitalia. The available data measurements collected. However, the raw data from this study collected was not viable as a general reflection of the female was not published, so the measurements and distributions could population due to small or homogeneous samples. Due to the not be stratified by someone without direct access to the study’s deviation in measurement tools and protocol, there is expected results. Another limitation to the utility of the data collected, as to be a substantial variation between studies on the exact acknowledged by the paper, is that the study population was numerical dimensions reported. ethnically and geographically homogeneous [4]. 1 Avery Smith is currently a student at Oregon State University 2 Contact author: [email protected]. V001T08A002-1 Copyright © 2020 ASME Table 1 lists all vulva vaginal dimension data sets that were discoverable using EBSCO’s academic database from 10.21.19 - 11.7.19. We excluded studies specifically aimed at gathering data regarding the genital anatomy of infants and fetuses. For ease of reading, Table 1 has been formatted in landscape orientation on the following page. Downloaded from http://asmedigitalcollection.asme.org/BIOMED/proceedings-pdf/DMD2020/83549/V001T08A002/6552698/v001t08a002-dmd2020-9025.pdf by guest on 24 September 2021 Table 2 lists the mean and standard deviation values for clitoral length, clitoral glans length, clitoral glans width, distance from clitoris to urethra, labia majora length, labia minora length and width, perineum length, vaginal length, and measurement tool used. We recorded the values from studies that observed women of age 18 years or older in Table 2. The reason for excluding data sets covering a majority of minors is that there are clear and obvious reasons behind the substantially lower mean values for those measurements. Studies that measured vulva vaginal dimensions, but reported one or fewer of the specific measurements listed above, were not included in Table 2. The purpose of showing these dimensions is to showcase the variation present in published data sets. For studies that analyzed and reported mean and standard deviation values separately between groups (such as parous versus nulliparous, or pre and postmenopausal women), the mean and SD averages were taken for the whole cohort and reported [7]. Table 2 can be found on page 5. V001T08A002-2 Copyright © 2020 ASME Downloaded from http://asmedigitalcollection.asme.org/BIOMED/proceedings-pdf/DMD2020/83549/V001T08A002/6552698/v001t08a002-dmd2020-9025.pdf by guest on 24 September 2021 Study Citation Sample Ethnicity / Race Age Vulva - Vaginal dimensions collected Size (yrs) Kreklau et al. 2018 Clitoral length and width, Distance of clitoris to urethra, Introitus opening, Length of perineum, 657 100% white 15-84 [4] Length of labia majora (left and right), Length and width of labia minora (left and right) Lloyd et al. 2005 74% - white, 10% - asian, Clitoral length and width, Clitoris to urethra, Labia majora length, Labia minora length and [5] 50 12% - black, 2% - mixed, 2% 18-50 width, perineum length, vaginal length, tanner stage, colour of genital area compared with - -latin american surrounding skin, rugosity of labia Clitoral length and width, Length and width of right and left labia, Distance from hiatus to anus, Haim et al. 2016 [6] 32 n/a 20-51 Distance from urethra to hiatus, Distance from urethra to clitoris, Distance from hiatus to clitoris, Length and width of hiatus, Depth of posterior fornix and anterior fornix. Brodie et al. Clitoral length and width, Length of labia majora, Length and width of labia minora, Distance 100 n/a 21-60 2008 [7] from clitoris to urethra, Perineal Length Veale et al. 2013 [8] 55 48-White, 2-Mixed, 3-Other 18-60 Width of labia minora umbilicus to pubic hairline / skin fold top of mons pubis, top of the mons pubis to the end of the labia majora, top of the mons pubis to the cleft, length of the labia majora (cleft to end of labia), Seitz et al. 2010 [9] 15; 13 n/a 26-95 lengths of the side segment lines (end of the labia majora along the inguinal crease up to the lateral hairline at the femoral vessels b), lengths of base of mons triangle, inguinal crease / pubic hairline angle ° , inguinal crease / labia majora angle Lykkebo et al. 2017 Labia minora length, Perineum length, Left and right labia minora width, mean width left and 244 100% - white 18-50 [10] right Clitoral glans length and width, clitoral prepuse length, clitoris to urethra, Urethra to vagina, Cao et al. 2014 [11] 319 100% - Chinese 18+ Vagina to perineum, Perineal body length, Labia minora length and width, Labia majora length and width, apex to clitoris glans, apex to perineum Weber et al. 1999 [12] 81 n/a 28 - 72 Vaginal length Akbiyik and Kutlu 1 mo - Clitoral length and width, labia majora length, left and right labia minora length and width, 205 n/a 2010 [13] 10 yrs perineal length 99% - White Verkauf et al. 1992 [14] 200 n/a Clitoral size 1% - Black Köşüş et al. 2016 [15] 67 100% turkish n/a Clitoral length, and labia minora length and width V001T08A002-3 Copyright © 2020 ASME Downloaded from http://asmedigitalcollection.asme.org/BIOMED/proceedings-pdf/DMD2020/83549/V001T08A002/6552698/v001t08a002-dmd2020-9025.pdf by guest on 24 September 2021 90% - White Oakley et al. 2014 [16] 30 n/a Clitoral size and location 10% - Other 22.7% - - Hispanic 72.7% - non - Hispanic 5% - unknown Clitoral hood length, Clitoral diameter, length of labia minora, clitoral hood to urethral orifice, Brodie et al. 2019 [17] 44 10-19 9% - African American width of labia minora, clitoral hood to lower border of pubic symphysis 86.4% - white 4.5% - other length of clitoral hood, length of sides of clitoral hood, clitoral diameter, apex of clitoral hood to Brodie et al. 2016 [18] 58 n/a 0-16 base of pubic symphysis, apex of clitoral hood to urethral orifice, distance of clitoral hood to labia majora, and length and depth of labia minora Chalmers et al. 2014 clitoris length and width, length from clitoris to anus, clitoris to urethra, clitoris to posterior labia 56 n/a <2 - 13 [19] majora, mucosa behind vagina or posterior fourchette, and radius to labia minora at vagina Battaglia et al. 2018 ultrasonographic translabial clitoral volume and labia minora thickness measurements and color 18 100% Caucasion 25-35 [20] Doppler assessment of the dorsal clitoral and posterior labial arteries Table 1, Cataloged studies, population demographics, and measurements taken V001T08A002-4 Copyright © 2020 ASME Downloaded from http://asmedigitalcollection.asme.org/BIOMED/proceedings-pdf/DMD2020/83549/V001T08A002/6552698/v001t08a002-dmd2020-9025.pdf