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

Vaginal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409902
• Other study ID #: 105827
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: April 22, 2013
• Start date: June 2008
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vaginal Prolapse

Locations

Country	Name	City	State
United States	USF STC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adequate visualization and access to cervix or vaginal vault		At time of speculum exam	No