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

This study has been completed.
Sponsor:
Collaborator:
MDI Worldwide LLC
Information provided by (Responsible Party):
D. Ashley Hill, MD, Florida Hospital
ClinicalTrials.gov Identifier:
NCT01670630
First received: August 7, 2012
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Comparison of a Sheathed Versus Standard Plastic Speculum
Procedure: Sheathed speculum examination
Procedure: Standard speculum examination

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Degree of cervix visualized. [ Time Frame: During vaginal speculum examination. ] [ Designated as safety issue: No ]
    To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.


Secondary Outcome Measures:
  • Comparison of pain during speculum examination. [ Time Frame: During speculum examination. ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 136
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Sheathed speculum examination
Other Names:
  • speculum
  • sheath
  • ClearSpec
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.
Procedure: Standard speculum 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670630

Locations
United States, Florida
Loch Haven Ob/Gyn Group
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Florida Hospital
MDI Worldwide LLC
Investigators
Principal Investigator: David A Hill, M.D. Florida Hospital
  More Information

No publications provided

Responsible Party: D. Ashley Hill, MD, Associate Director, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education, Florida Hospital
ClinicalTrials.gov Identifier: NCT01670630     History of Changes
Other Study ID Numbers: CS201202
Study First Received: August 7, 2012
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Florida Hospital:
speculum
vagina
cervix
examination

ClinicalTrials.gov processed this record on April 15, 2014