Anterior Pelvic Organ Prolapse Clinical Trial
— Anterior SISOfficial title:
Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
| Verified date | August 2016 |
| Source | University of Calgary |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | April 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Foothills Medical Centre | Calgary | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Calgary | Alberta Health Services, Cook |
Canada,
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):288-94. doi: 10.1097/AOG.0000000000000105. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative) | 12 months postoperatively | No | |
| Secondary | Change in point Ba (on POP-Q) from baseline | 12 months postoperatively | No | |
| Secondary | Pelvic Organ Prolapse Quantification(POP-Q) stage | 12 months postoperatively | No | |
| Secondary | Change in POP-Q stage from baseline | 12 months postoperatively | No | |
| Secondary | Postoperative complications | 12 months postoperatively | Yes | |
| Secondary | Pelvic Floor Distress Inventory short form-20 (PFDI-20) | 12 months postoperatively | No | |
| Secondary | Pelvic Floor Impact Questionnaire short form-7 (PFIQ-7) | 12 months postoperatively | No | |
| Secondary | Sexual function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | 12 months postoperatively | Yes | |
| Secondary | Surgical complications | Up to 6 weeks postoperatively | Yes | |
| Secondary | Satisfaction with surgical outcome | 12 months postoperatively | No |