Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 80
Updated:3/30/2013
Start Date:June 2008
End Date:April 2013
Contact:Erich Wyckoff, MD
Email:ewyckoff@health.usf.edu
Phone:813-259-6053

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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.


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)

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.
We found this trial at
1
site
Tampa, Florida 33549
?
mi
from
Tampa, FL
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