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

Sponsor
University of South Florida (Other)
Overall Status
Completed
CT.gov ID
NCT01409902
Collaborator
(none)
38
Enrollment
1
Location
57
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    38 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
    Study Start Date :
    Jun 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Mar 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with adequate visualization and access to cervix or vaginal vault [At time of speculum exam]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USF STC Tampa Florida United States 33549

    Sponsors and Collaborators

    • University of South Florida

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of South Florida
    ClinicalTrials.gov Identifier:
    NCT01409902
    Other Study ID Numbers:
    • 105827
    First Posted:
    Aug 4, 2011
    Last Update Posted:
    Apr 23, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Uterine Prolapse
    Prolapse

    Study Results

    No Results Posted as of Apr 23, 2013