Clinical trial NCT00955448: Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study
Official title: Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Pelvic Organ Prolapse
Keywords: Anterior pelvic organ prolapse
Surgical repair
Pelvic floor surgery
Randomized clinical trial
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Cook Group Incorporated
name: Alberta Health services
First posted: 2009-08-10
Enrollment: 57
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative)
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Change in point Ba (on POP-Q) from baseline
timeFrame: 12 months postoperatively
measure: Pelvic Organ Prolapse Quantification(POP-Q) stage
timeFrame: 12 months postoperatively
measure: Change in POP-Q stage from baseline
timeFrame: 12 months postoperatively
measure: Postoperative complications
timeFrame: 12 months postoperatively
measure: Pelvic Floor Distress Inventory short form-20 (PFDI-20)
timeFrame: 12 months postoperatively
measure: Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7)
timeFrame: 12 months postoperatively
measure: Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
timeFrame: 12 months postoperatively
measure: Surgical complications
timeFrame: Up to 6 weeks postoperatively
measure: Satisfaction with surgical outcome
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Magali Robert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robert M, Girard I, Brennand E, Tang S, Birch C, Murphy M, Ross S. Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):288-294. doi: 10.1097/AOG.0000000000000105.