A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix

AdventHealth136 enrolled

Overview

The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination.

This is a randomized trial where physician investigators will perform clinically indicated vaginal speculum examinations using either a sheathed or a standard plastic speculum, to determine which speculum provides the best visualization of the cervix. As a secondary outcome, study participants will record their pain level on a 10-cm visual analogue scale.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

136

Conditions

Comparison of a Sheathed Versus Standard Plastic Speculum

Interventions

Sheathed speculum examinationPROCEDURE

Standard speculum examinationPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing clinically indicated vaginal speculum examination. * Subject has had at least 1 prior vaginal deliver \> 20 weeks gestational age. * Able to read and speak English. Exclusion Criteria: * Active vulvar lesions or conditions (sexually transmitted infections, vestibulodynia, candida, vaginitis, or vulvar dermatologic condition). * Menopausal or using hormone replacement therapy. * Genital atrophy. * Chronic pelvic pain, dyspareunia, or interstitial cystitis.

Locations (1)

Loch Haven Ob/Gyn Group

Orlando, Florida, United States

Outcomes

Primary Outcomes

Degree of cervix visualized.

To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.

Time frame: During vaginal speculum examination.

Secondary Outcomes

Comparison of pain during speculum examination.

To compare the subjects' comfort level between the sheathed and standard speculums when undergoing a vaginal speculum examination, using a patient-reported 10-cm visual analog scale (VAS).

Time frame: During speculum examination.

Data from ClinicalTrials.gov

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