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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
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Study Description
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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
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 Design
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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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with adequate visualization and access to cervix or vaginal vault [ Time Frame: At time of speculum exam ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
excessive vaginal tissue
Criteria

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
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Information from the National Library of Medicine

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


Locations
United States, Florida
USF STC
Tampa, Florida, United States, 33549
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Erich Wyckoff, M University of South Florida
More Information
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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