Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
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ClinicalTrials.gov Identifier: NCT01409902 |
Recruitment Status
:
Completed
First Posted
: August 4, 2011
Last Update Posted
: April 23, 2013
|
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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 |
---|
Vaginal Prolapse |
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 : | June 2008 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |
- Number of patients with adequate visualization and access to cervix or vaginal vault [ Time Frame: At time of speculum exam ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409902
United States, Florida | |
USF STC | |
Tampa, Florida, United States, 33549 |
Principal Investigator: | Erich Wyckoff, M | University of South Florida |
Responsible Party: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT01409902 History of Changes |
Other Study ID Numbers: |
105827 |
First Posted: | August 4, 2011 Key Record Dates |
Last Update Posted: | April 23, 2013 |
Last Verified: | April 2013 |
Additional relevant MeSH terms:
Prolapse Uterine Prolapse Pathological Conditions, Anatomical |
Uterine Diseases Genital Diseases, Female Pelvic Organ Prolapse |