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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Comparison of a Sheathed Versus Standard Plastic Speculum

Intervention / Treatment
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* Procedure: Sheathed speculum examination
* Procedure: Standard speculum examination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sheathed speculum<br>Investigators will perform a vaginal speculum examination with either a sheathed or a standard (non sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception. | Procedure: Sheathed speculum examination<br> <br> * Other names: ClearSpec;|
| Active Comparator: Standard speculum examination<br>Investigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception. | Procedure: Standard speculum examination<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During vaginal speculum examination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | During speculum examination. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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speculum, vagina, cervix, examination