Traditional vs. Graft-augmented Posterior Colporrhaphy - Full Text View

Sponsor:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00581594

Purpose

Women who undergo posterior colporrhaphy with graft augmentation will have a lower recurrence of their posterior wall defect than women who undergo a traditional posterior colporrhaphy.

Condition	Intervention
Pelvic Organ Prolapse Posterior Vaginal Wall Defects	Procedure: Graft-augmented colporrhaphy Procedure: Traditional posterior colporrhaphy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Traditional vs. Graft-augmented Posterior Colporrhaphy: A Randomized Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

The primary outcome of recurrence of stage II posterior wall defects will be measured using the pelvic organ prolapse quantification exam (POPQ). [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcomes will be measuring the effects of the surgical repair on various aspects of life using a series of questionnaires: SF-36 as a measure of quality of life, PISQ to measure sexual function, and FISI to measure rectal function. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Posterior repair with graft augmentation.	Procedure: Graft-augmented colporrhaphy Patients will undergo randomized surgical procedure. Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall. Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen. Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver. Patients will be seen at 6 months for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI. Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse. Patients will be seen at 1 year and yearly intervals up to five years for a pelvic exam for evaluation of posterior wall support and the questionnaires. Other Name: Xenform® material
2 Posterior repair without graft augmentation.	Procedure: Traditional posterior colporrhaphy Patients will undergo randomized surgical procedure. Patients will be seen at 2 weeks for routine post-op care and evaluation of any post-op complications. Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall. Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen. Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver. Patients will be seen at 6 months, for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI. Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse. Patients will be seen at 1 year and yearly intervals up to five years to have a pelvic exam for evaluation of posterior wall support and the questionnaires.

Arms

Assigned Interventions

1

Posterior repair with graft augmentation.

Procedure: Graft-augmented colporrhaphy

Patients will undergo randomized surgical procedure. Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall. Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen. Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver. Patients will be seen at 6 months for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI. Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse. Patients will be seen at 1 year and yearly intervals up to five years for a pelvic exam for evaluation of posterior wall support and the questionnaires.

Other Name: Xenform® material

2

Posterior repair without graft augmentation.

Procedure: Traditional posterior colporrhaphy

Patients will undergo randomized surgical procedure. Patients will be seen at 2 weeks for routine post-op care and evaluation of any post-op complications. Patients will be seen at 6 weeks for a pelvic exam and evaluation of the posterior wall. Points Ap and Bp will be recorded with values at 0.5cm intervals being on the posterior vaginal wall that is 3cm above the hymen. Point Bp is the most dependent portion of the posterior vaginal wall when the patient performs a Valsalva maneuver. Patients will be seen at 6 months, for a pelvic exam evaluation of posterior wall support and completion of SF-36, PISQ and FISI. Patients will be given 60 minute Questionnaires on defecatory dysfunction, pelvic pain and/or symptoms of prolapse. Patients will be seen at 1 year and yearly intervals up to five years to have a pelvic exam for evaluation of posterior wall support and the questionnaires.

Detailed Description:

The traditional approach to surgical repair of posterior wall defect is the posterior colporrhaphy. Although this technique has been successful in the anatomic correction of the defect, the functional outcomes have been disappointing. This fact suggests improvement in the functional and anatomic outcomes following a traditional posterior colporrhaphy. Consequently, the idea of incorporating graft material into the repair to augment the patient's own tissue has been examined. Placing a piece of graft material in between the vagina and rectum adds an extra layer of support and thus augments the strength of the repair. The purpose of this study is to evaluate the anatomic and functional outcomes of posterior compartment, graft-augmented traditional posterior colporrhaphy vs. traditional posterior colporrhaphy alone.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years old
Posterior wall defect with point Ap or Bp at 0 or greater
Desires surgical correction
Willing to accept randomization to graft vs. no graft
Competent to sign an informed consent
Completed childbearing
Non-pregnant

Exclusion Criteria:

Current anal sphincter disruption with planned incontinent surgical repairs
Poor surgical candidate
History of rectal cancer or inflammatory bowel disease
Current rectovaginal
History of vaginal cancer
History of vaginal/pelvic radiation
Foreshortened vagina
Previous adverse reaction to Xenform matrix graft material

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581594

Locations

United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

Karen L Noblett, M.D.

University of California, Irvine

More Information

No publications provided

Responsible Party:	Karen Noblett, Associate Professor, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier:	NCT00581594 History of Changes
Other Study ID Numbers:	2005-4574
Study First Received:	December 20, 2007
Last Updated:	August 5, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Pelvic organ prolapse
Posterior wall defects
Graft-augmented repair
Posterior colporrhaphy

Additional relevant MeSH terms:

Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 12, 2012