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Completed

NCT Number: NCT00955448

Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study

Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.

One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.

Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.

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Key information

Conditions

Anterior Pelvic Organ Prolapse

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Foothills Medical Centre

Calgary, Alberta, T2N 1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who require surgical correction for anterior compartment prolapse. (Concomitant surgery is permitted.)
  • Point Ba of 0 or greater: that is a positive Ba, indicating that the prolapse is beyond the introitus, not within the vagina.
  • Patient must consent to participate in the study.

Exclusion criteria

  • Having an obliterative procedure (Lefort procedure or colpocleisis).
  • Allergy to graft material.
  • Immunocompromised.
  • Previous anterior compartment repair.
  • Are unable to understand English.
  • Will be unavailable for follow-up.

Treatment and study plan

SIS mesh (Cook Medical)

Device

Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)

Anterior prolapse repair

Procedure

Anterior prolapse repair will be conducted without using mesh reinforcement

Primary outcomes

  1. Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative)

    Time frame: 12 months postoperatively

Secondary outcomes

  1. Change in point Ba (on POP-Q) from baseline

    Time frame: 12 months postoperatively

  2. Pelvic Organ Prolapse Quantification(POP-Q) stage

    Time frame: 12 months postoperatively

  3. Change in POP-Q stage from baseline

    Time frame: 12 months postoperatively

  4. Postoperative complications

    Time frame: 12 months postoperatively

  5. Pelvic Floor Distress Inventory short form-20 (PFDI-20)

    Time frame: 12 months postoperatively

  6. Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7)

    Time frame: 12 months postoperatively

  7. Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)

    Time frame: 12 months postoperatively

  8. Surgical complications

    Time frame: Up to 6 weeks postoperatively

  9. Satisfaction with surgical outcome

    Time frame: 12 months postoperatively

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services
  • Cook Group Incorporated

Registry information

Official study title

Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study

Acronym: Anterior SIS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2009
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.