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

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.

• Procedure: Sheathed speculum examination
  Other Names:

  • speculum
  • sheath
  • ClearSpec
• Procedure: Standard speculum examination

• Active Comparator: Sheathed speculum
  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.
  Intervention: Procedure: Sheathed speculum examination
• Active Comparator: Standard speculum examination
  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.
  Intervention: Procedure: Standard speculum examination

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.