Clinical trial NCT05254756: "Pilot Study: A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"
Official title: "A Comparison of the Bouquet Speculum and the Traditional 2-Bladed Speculum"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Exam
Lead sponsor: Rocky Vista University, LLC
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized single-blinded clinical study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient comfort
timeFrame: Immediately after the exam
measure: Length of time
timeFrame: During the exam
measure: Ease of use
timeFrame: Immediately after the exam
Secondary outcomes:
Other outcomes:
Locations:
city: Saint George
country: United States
facility: St. George OB/GYN
state: Utah
Study officials:
affiliation: Rocky Vista University
name: James M Small, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouquet JM, Chernau A, McLaughlin R, Choudhury Q. 2019. A New Vaginal Speculum and an Inexpensive Kit to Screen and Treat Dysplasia and Cancer of the Cervix. Journal of Women's Health Care. 8.470 doi: 10.35248/2167-0420.19.8.470