Using a Sheathed Speculum to Visualize and Access the Cervix in Women With Excessive Vaginal Tissue
|ClinicalTrials.gov Identifier: NCT00595166|
Recruitment Status : Terminated (Design changed to observational, not RCT. PI left USF; study closed.)
First Posted : January 16, 2008
Last Update Posted : April 6, 2016
This new invention addresses the inadequate and incomplete visualization of the cervix in patients with excessive vaginal tissue. In general these patients are obese, or are multiparous with a history of multiple vaginal deliveries.
A vaginal speculum is a vital medical instrument that allows a health care provider to visualize the interior aspects of the vagina, as well as the distal portion of the uterus, the cervix. It is composed of 2 blades assembled together and held by a handle. The blades and the handle form a 90 degree-angle. As the user holds the handle, a lever attached to the top blade allows it to open away from the inferior blade.
When the instrument is inserted into the vagina, the two blades are separated in order to keep the anterior and posterior vaginal walls apart. In that position, the cervix and the walls of the vagina can be seen if the patient does not have an excess of loose vaginal tissue. However, in patients with excessive tissue, the sidewalls of the vagina simply collapse toward the midline between the blades because of the fact that no part of the speculum is in direct contact with the lateral walls of the vagina. This collapse prevents the complete and crucial visualization of the cervix for purposes of cervical cultures, pap smears, visual assessment of ruptured membranes, visual assessment of the degree of dilation, biopsies, and other procedures requiring access to the cervix or the uterus.
When clinicians face this dilemma, they may try the largest speculum available, and will open it as wide as possible in order to keep the lateral walls apart. Most often, they have to improvise by cutting the tip of a condom, or the thumb off a glove, or they use a sterile lateral-wall retractor. These other creative solutions can take several minutes of precious times and may still result in an inadequate visualization and suboptimal access.
A vaginal speculum sheath for retaining vaginal tissue in a lateral direction conforms to a pair of blades that are movable between an opened position and a closed position. The blades in the closed position are adapted for insertion into a vagina, and in the open position, they allow dilating the vagina in order to provide access to the cervix.
This new design includes a flexible, transparent polyurethane sleeve structure that extends between the blades when the speculum is opened. The stretched sheath is adapted to retain the lateral walls of the vagina in the open position. The elastic sleeve is designed to remain in a collapsed configuration when the blades are in a closed position to avoid interfering with insertion or withdrawal of the speculum [Reference: U.S. patent 6432048 (2002-8-13)]. Polyurethane material is FDA approved for vaginal use.
The purpose of this study is to compare standard of care speculum vs. sheathed speculum in the examination of patients with collapsing vaginal sidewalls during a gynecological speculum exam.
The primary hypothesis testing for this study will be to compare the standard of care speculum exam to a sheathed speculum exam in a prospective, randomized clinical trial.
|Condition or disease||Intervention/treatment|
|Healthy||Device: Vaginal Speculum Sheath|
|Study Type :||Observational|
|Actual Enrollment :||38 participants|
|Official Title:||Using a Sheathed Speculum to Visualize and Access the Cervix in Women With Excessive Vaginal Tissue|
|Study Start Date :||June 2007|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
Speculum Sheath group. Participants all received the speculum sheath.
Device: Vaginal Speculum Sheath
Patients received the sheathed speculum exam: The clinician will begin to place the sheath onto the speculum. The sheath is attached to a thin piece of cardboard. The proximal end of the cardboard is placed between the speculum blades and is pushed toward the speculum handle. The blades of the speculum are simultaneously guided to enter the 2 pockets of the sleeve, like fingers going into a glove. The speculum exam will then be completed according to usual procedures. In the event the sheathed speculum exam is unsatisfactory the clinician will do standard of care (the clinician's usual routine at the bedside).
- The main objective of the study is to assess the effectiveness of a sheathed speculum compared to standard of care procedures in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue. [ Time Frame: Once the cervix is visualized, the timing of the procedure will stop. ]
- The two speculum examination procedures will also be timed from the moment of randomization to the visualization of the cervical os. [ Time Frame: Once the cervix is visualized, the timing of the procedure will stop. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595166
|United States, Florida|
|USF South Tampa Center for Advanced Healthcare|
|Tampa, Florida, United States, 33606|
|Principal Investigator:||Rony Francois, MD, PhD||University of South Florida|