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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Prolapse

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)

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33549
      • USF STC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

excessive vaginal tissue

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adequate visualization and access to cervix or vaginal vault	At time of speculum exam

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Erich Wyckoff, M, University of South Florida

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (Estimate): August 4, 2011

Study Record Updates

• Last Update Posted (Estimate): April 23, 2013
• Last Update Submitted That Met QC Criteria: April 22, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse
• Other Study ID Numbers: 105827