"Pilot Study: A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"

Isain Zapata

Status: Terminated

Conditions: Pelvic Exam

Treatments: Device: Traditional plastic 2-blade disposable speculum; Device: Bouquet speculum

Study type: Interventional

Funder types: Other

Identifiers

NCT05254756

IRB #2020--0110

Details and patient eligibility

About

This randomized single-blinded clinical study will compare the typical 2-bladed plastic disposable vaginal speculum to the novel 5-petal Bouquet speculum on level of patient comfort, visibility of the cervix, and time length of the examination. The data will be collected via patient and provider questionnaires.

Full description

For nearly 200 years, the traditional 2-blade "Duck bill" vaginal speculum has had very little evolution in design. In past decades, there has been an increase in popularity in using the plastic speculum rather than the metal speculum. The plastic speculum has effectively the same design as the traditional metal vaginal speculum. The current 2-blade design that has been used for centuries leaves many women feeling pain or discomfort during a speculum vaginal exam. Furthermore, in obese and multiparous women, the 2-blade design often allows the lateral walls of the vagina to cave inward during the exam, preventing the provider from gaining full visibility of the cervix. Another common complaint is that the exam takes too long, which leaves patients in pain and feeling vulnerable for an extended period of time.

The novel 5-petal Bouquet vaginal speculum offers an alternative design that some have argued provides enhanced patient comfort, better visualization of the cervix, and is easier to use for the provider. This proposed study design is a blueprint that will be used to compare the Bouquet speculum to a traditional 2-blade disposable plastic speculum on patient comfort, visualization of the cervix, and ease of use for the provider. The investigators predict that the results of this study will help physicians and other medical providers provide patients with better experience, reducing or eliminating the current common complaints regarding how speculum exams are performed today.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female patients that require a pelvic exam.
• 18 years of age or older
• Having had at least one previous pelvic exam with the traditional speculum
• Consent to participate in the study

Exclusion criteria

• Never had a pelvic exam before

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups

Traditional plastic 2-blade disposable speculum

Active Comparator group

Description:

Patients assigned to this arm will be evaluated using the traditional plastic 2-blade disposable speculum

Treatment:

Device: Traditional plastic 2-blade disposable speculum

5-petal Bouquet speculum

Experimental group

Description:

Patients assigned to this arm will be evaluated using the 5-petal Bouquet speculum

Treatment:

Device: Bouquet speculum