Status:
COMPLETED
Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
Lead Sponsor:
University of South Florida
Conditions:
Vaginal Prolapse
Eligibility:
FEMALE
18-80 years
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 sec...
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. Eligibl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01409902
Start Date
June 1 2008
End Date
March 1 2013
Last Update
April 23 2013
Active Locations (1)
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1
USF STC
Tampa, Florida, United States, 33549