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

NCT01409902 | Completed DMC

• 1 other identifier: 105827
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginal Prolapse

Outcome Measures

Primary Outcomes (1)

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

  At time of speculum exam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

excessive vaginal tissue

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

USF STC

Tampa, Florida, 33549, United States

Location

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Erich Wyckoff, M

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 4, 2011
• Study Start: June 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)