Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue

Completed

Conditions studied: Vaginal Prolapse

In brief

The main objective of the study is to assess the effectiveness of the sheathed speculum in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue. The secondary objective is to rate the patient's comfort evaluation during the sheathed speculum examination.

Key facts

Study ID

NCT01409902

Run by

University of South Florida

People needed

38

Starts

2008-06-01

Expected to finish

2013-03-01

Last updated by the study team

2013-04-23

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age 18 to 64 years
• BMI greater than 30 (or see next line)
• Collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a BMI >30 would also qualify the patient for the study).
• Able to provide written informed consent

You may not qualify if…

• Patients unwilling to participate in the study or provide consent Presence of significant acute pelvic pain syndromes (ie exacerbation of dyspareunia, chronic pelvic pain or pelvic floor dysfunction, atrophic vaginitis, interstitial cystitis, endometriosis) which, in the opinion of the examining clinician, could potentially confound the patient's responses to the questionnaire
• Presence of active genital herpes
• Presence of significant condyloma acuminata (may be an investigator decision)
• Any other patient deemed inappropriate for the study by the consenting or examining investigator.

Where it is running

• USF STC — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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