Traditional vs. Graft-augmented Posterior Colporrhaphy

NCT00581594 | Terminated DMC

• 1 other identifier: 2005-4574
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Organ Prolapse; Posterior Vaginal Wall Defects

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary outcome of recurrence of stage II posterior wall defects will be measured using the pelvic organ prolapse quantification exam (POPQ).

  5 Years

Secondary Outcomes (1)

• 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.

  5 Years

Study Arms (2)

1

OTHER

Posterior repair with graft augmentation.

Procedure: Graft-augmented colporrhaphy

2

OTHER

Posterior repair without graft augmentation.

Procedure: Traditional posterior colporrhaphy

Interventions

Graft-augmented colporrhaphy PROCEDURE

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.

Also known as: Xenform® material

1

Traditional posterior colporrhaphy PROCEDURE

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen L Noblett, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 27, 2007
• Study Start: January 1, 2006
• Primary Completion: October 11, 2008
• Study Completion: October 11, 2008
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

US (1)