NCT01409902

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a descriptive clinical trial designed to assess the efficacy of a sheathed speculum in providing adequate visualization and access to the cervix in women with excessive vaginal tissue. Eligible, consented subjects who fail their initial speculum examination (because their cervix is not visualized due to the collapse of loose lateral vaginal walls) will have a sheathed speculum examination instead of the standard-of-care exam whereby the clinician fabricates a solution at the bedside (condom with tip cut placed on speculum, concomitantly using an additional instrument like a lateral-wall retractor, glove with tip of thumb placed over the speculum, using the largest speculum available)

Conditions

• Vaginal Prolapse

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-08-04
• Last updated: 2013-04-23

Locations

1 site across 1 country: United States