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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

August 2, 2011
August 4, 2011
April 23, 2013
June 2008
March 2013   (Final data collection date for primary outcome measure)
Number of patients with adequate visualization and access to cervix or vaginal vault [ Time Frame: At time of speculum exam ]
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Complete list of historical versions of study NCT01409902 on ClinicalTrials.gov Archive Site
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Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
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.

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)
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
excessive vaginal tissue
Vaginal Prolapse
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
42
March 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01409902
105827
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University of South Florida
University of South Florida
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Principal Investigator: Erich Wyckoff, M University of South Florida
University of South Florida
April 2013