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The Improvement Of Pelvic Exams for Patients With Chronic Vulvovaginal Conditions

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Drexel University

Status

Completed

Conditions

Pain

Treatments

Diagnostic Test: Experimental Pelvic Exam

Study type

Interventional

Funder types

Other

Identifiers

NCT03393910
DrexelU

Details and patient eligibility

About

The purpose of this study is to investigate patients self-reported comfort levels during each section of the pelvic exam.

Full description

The purpose of this randomized controlled trial is to investigate the sequence in which physicians perform the pelvic exam, describe and compare self-reported comfort during each section of the pelvic exam and how comfort during the examinations related to quality of life, self-esteem, and sexual function in English speaking females at least 18 years of age with chronic vulvovaginal conditions.

Enrollment

200 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • English Speaking Are able to read and write English Are utilizing outpatient services and being seen for a first appointment at an outpatient Vulvodynia Center

Exclusion criteria

  • Non English Speaking
  • Patients who cannot read or write
  • Those who are pregnant
  • Those who do not have a chronic vulvovaginal condition
  • Patients other than "new" patients
  • Patients who would not otherwise need a speculum exam

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups

Observational
No Intervention group
Description:
Normal pelvic exam exposures: External exam followed by speculum exam, followed by bimanual exam
Experimental Pelvic Exam
Active Comparator group
Description:
Changing the order of the pelvic exam Intervention: External exam, bimanual exam,speculum exam
Treatment:
Diagnostic Test: Experimental Pelvic Exam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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