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Completed

NCT Number: NCT01409902

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients with adequate visualization and access to cervix or vaginal vault

    Time frame: At time of speculum exam

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2011
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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