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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pelvic Exam
• Intervention / Treatment: Device: Traditional plastic 2-blade disposable speculum; Device: Bouquet speculum

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Saint George, Utah, United States, 84790
      • St. George OB/GYN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional plastic 2-blade disposable speculum; Patients assigned to this arm will be evaluated using the traditional plastic 2-blade disposable speculum	Device: Traditional plastic 2-blade disposable speculum; Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient
Experimental: 5-petal Bouquet speculum; Patients assigned to this arm will be evaluated using the 5-petal Bouquet speculum	Device: Bouquet speculum; Quantitative assessments of visualization of cervix, ease-of-use by the provider, and comfort of the patient; Other Names: 884.4520

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comfort	Find the difference in the level of patient comfort during a vaginal speculum exam between the traditional 2-blade plastic disposable speculum and the 5-petal Bouquet speculum. Assessed with a questionnaire answered by the patient: What was the level of comfort with this Pap smear compared to other speculum exams you have had? (More comfortable, Same level of comfort/discomfort, Less comfortable ); Based on what you anticipated the exam was:(More comfortable, As comfortable/uncomfortable, Less comfortable); On a scale from 0 to 10, what is the highest level of pain you experienced during the Pap smear/speculum exam? (10 being the worst pain you have ever experienced, and 0 being no pain); Did the doctor who performed the exam ask you adjust your body position while the speculum was inserted? (Yes, No); What is your estimation of how long the speculum was inserted? (0-30 seconds, 30-60 seconds, 1-2 minutes, 2-3 minutes, >3 minutes)	Immediately after the exam
Length of time	Find the difference in the length of time that the Bouquet speculum is inserted during a Pap smear compared to the traditional 2-blade speculum. The time the speculum is inserted is recorded for every interactions.	During the exam
Ease of use	Find the difference in ease of use for the provider between the traditional 2-blade plastic disposable speculum and the 5-petal Bouquet speculum. Assessed with a questionnaire answered by the provider: During the speculum exam, were the lateral walls of the cervix easily visualized upon initial visualization of the cervix? (Yes, No); What is your estimate of how long the speculum was inserted? (0-30 seconds, 30-60 seconds, 1-2 minutes, 2-3 minutes, >3 minutes); While the speculum was inserted, was the patient asked to adjust body position in order to gain a better view of the cervix? (Yes, No); Were special maneuvers performed in order to better visualize the cervix? (e.g. use a different size/type of speculum, apply a condom over the speculum to view the lateral walls, re-insert the speculum, etc.)? (Yes, No)	Immediately after the exam

Collaborators and Investigators

• Sponsor: Isain Zapata
• Investigators: Principal Investigator: James M Small, MD, Rocky Vista University

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB #2020--0110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Unidentified data will be shared when reasonable request is asked to the principal investigator. however this is yet to be decided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No