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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01670630

Enrollment

136

Registered

2012-08-22

Start date

2012-07-31

Completion date

2013-02-28

Last updated

2013-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of a Sheathed Versus Standard Plastic Speculum

Keywords

speculum, vagina, cervix, examination

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESheathed speculum examination

PROCEDUREStandard speculum examination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Degree of cervix visualized.	During vaginal speculum examination.	To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.

Secondary

Measure	Time frame	Description
Comparison of pain during speculum examination.	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026