A Disposable Vaginal Speculum is typically used to get a clear view of the cervix during cervical cancer screening. Fear of pain, discomfort, and shame is one potential barrier to screening. The purpose of this study is to present and illustrate the possibility of using a tampon-sized inserter and the Pocket Colposcope, a minuscule pen-sized colposcope, for comfortable, speculum-free, and potentially self-colposcopy.
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Study Design of Disposable Vaginal Speculum
Using 3D computer-aided design (CAD) software, we investigated various designs and ran mechanical testing simulations on each. To determine an optimal design, designs were rapidly prototyped and evaluated utilizing a unique vaginal phantom over a range of vaginal pressures and uterus tilts. Two final designs were tested on fifteen volunteers to compare cervical visualization, comfort, and usefulness to the Disposable Vaginal Speculum, and the best design, the curved-tip inserter, was chosen for testing in volunteers.
Results of Disposable Vaginal Speculum
As an alternative to the traditional speculum for use with the Pocket Colposcope, we provide a vaginal inserter. The device comprises a slender tubular body with a curved funnel-like tip of around 2.5 cm in diameter. The inserter includes a channel via which a 2-megapixel (MP) tiny camera with LED illumination can be inserted to capture images. Mechanical finite element testing simulations with an applied pressure of 15 cm H2O revealed that the inserter has a high factor of safety (90.9). The device captured images with a visual area comparable to the disposable vaginal speculum for a normal/axially positioned uterus and significantly better than the speculum for anteverted and side-vested uteri (p0.00001) when tested with a custom vaginal phantom across a range of supine vaginal pressures and uterine tilts (retroverted, anteverted, and sideverted).
Voluntary studies using self-insertion and physician-assisted cervix image capture revealed that 83% of patients had acceptable cervix visibility.
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Furthermore, volunteer questionnaire responses revealed a 92.3% overall preference for the inserter over the speculum, with all indicating that the inserter was more pleasant than the speculum. The inserter serves as a platform for self-cervical cancer screening and also allows for the application of acetic acid/iodine Lugol and the insertion of swabs for Pap smear sample collection.
A Significant Component in Women’s Resistance
The speculum has been identified as a significant component in women’s resistance to cervical cancer screening, owing mostly to anxiety, fear, discomfort, pain, shame, and/or vulnerability during the process. A study of 354 women in Moshi, Tanzania, discovered that the major criteria for cervical cancer screening were significant worries about shame and pain during speculum screening, as well as physician gender. In Australia, a study comparing physician versus self-insertion of the standard speculum discovered that 91% of 133 women would prefer self-insertion over physician insertion and that women have expressed discomfort, embarrassment, and vulnerability when having another person insert a device and examine their cervix.
Despite better access to healthcare in the United States, compliance rates for cervical cancer screening vary, and embarrassment and fear of discomfort during the inspection have been cited as potential barriers to screening. The speculum causes discomfort, especially for women who have vaginismus, a disorder characterized by involuntary vaginal tightening caused by sexual abuse. Tanzania, for example, has one of the worst rates of sexual assault in the world, as well as the highest rates of cervical cancer incidence and mortality. As a result, it is these women that require the most regular cervical screening, as well as a less unpleasant and invasive screening procedure that does not require the use of a speculum.
Father of Gynaecology
Since the ninth century, many shapes and forms of the speculum have existed, and hundreds of alterations have been made in an attempt to improve exposure. The “father of gynecology,” J. Marion Sims, created the first crude version of the modern speculum out of a bent spoon. The manufacturer Charriere, who introduced the bivalve, tri-blade, and four-blade speculums, proposed the resemblance to the normal bivalve speculum. This was the inspiration for the duckbill designs of the well-known Cusco speculum in 1870 and the Graves speculum in 1878. This is a cold, hard metal device with two bills that expands the entire vaginal canal.
There have been few advancements to make duck-billed speculums more pleasant and acceptable to women since their introduction. Minor design adjustments have included introducing a range of sizes and manufacturing the speculum out of plastic, among other things. Modern disposable vaginal speculums are designed for external use, making self-insertion by women challenging. Being able to self-insert is essential for re-adjustment. While you are in pain. Additionally, increased manipulation or the use of an additional device, such as a side wall retractor, is required in cases when women have tilted uterus or lax vaginal walls due to having a bigger body size or a high parity. This adds to the discomfort and anguish of vaginal examinations.