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Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging

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ClinicalTrials.gov Identifier: NCT00988975
Recruitment Status : Unknown
Verified October 2009 by Urogynecology Associates, Indiana.
Recruitment status was:  Recruiting
First Posted : October 2, 2009
Last Update Posted : October 2, 2009
Information provided by:

September 30, 2009
October 2, 2009
October 2, 2009
September 2009
December 2012   (Final data collection date for primary outcome measure)
Anatomic success of rectocele repair [ Time Frame: 6 months ]
Same as current
No Changes Posted
change in patient symptomatology post-operatively [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging
Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?
Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Procedure: Insertion of pelvicol graft
Pelvicol graft
  • Active Comparator: Pelvicol graft
    Intervention: Procedure: Insertion of pelvicol graft
  • No Intervention: No graft material
    No graft material
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

Exclusion Criteria:

  • concomitant colo-rectal procedure
  • allergy to pork
  • any contraindication to laparoscopic sacrocolpopexy
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Douglass Hale, MD, Urogynecology Associates
Urogynecology Associates, Indiana
Not Provided
Not Provided
Urogynecology Associates, Indiana
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP