Pelvic Organ Prolapse
Conditions
Keywords
pelvic organ prolapse, vaginal graft
Brief summary
This is a randomized control trial comparing anterior colporrhaphy with augmentation with dermal allograft (ARCUS) to anterior colporrhaphy with a suture-based repair (native tissue). Patients were randomized to one treatment and then were followed post-operatively for 7-10 years. Prior to surgery patients had a POPQ vaginal prolapse exam and completed a quality of life questionaire (PFDI). They had a repeat POPQ exam and quality of life questionaires at their post-op operative visits. We compare recurrent prolapse rates between these 2 groups.
Detailed description
Objective: To determine whether dermal allograft (ARCUS) reduces anterior prolapse recurrence at 1 and 7-10 years post-operatively. Our central question is whether we can reduce the rate of rate of anterior compartment prolapse recurrence after surgical repair, is the recurrence rate reduced with allograft use, and does this benefit hold up over time? Methods: Patient will be randomized by computer generated block randomization to native tissue (suture based) anterior colporrhaphy or colporrhaphy with graft (ARCUS) usage. Neither patients nor surgeons will be blinded due to the nature of the surgery. Patients will be followed for 7-10 years post-operatively. Participants will complete a POPQ exam and the PFDI (Pelvic Floor Distress Inventory) questionnaire pre-operatively. Patients will return for a POPQ exam at 1 year post-operatively and complete the PFDI (Pelvic Floor Distress Inventory) and PISQ (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence) questionnaires. Patients will be asked to return to the office for a research visit 7-10 years post-operatively for a POPQ exam and to complete quality of life questionnaires including PFDI 20 (Pelvic floor distress inventory), PISQ-R (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal Incontinence, Revised), and PGI (Patient global assessment of improvement).
Interventions
PROCEDUREdermal graft (ARCUS repliform) for anterior colporrhaphy
At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation
PROCEDUREsuture based anterior colporrhaphy
At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
Any patient planning to undergo surgery for anterior compartment prolapse, English speaking. \-
Exclusion criteria
Any patient who does not speak English due to standardized English language based questionaires, and patients without anterior compartment prolapse. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-Year Recurrent prolapse- anatomic | 1 year post-operative | Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater |
| 7-10 Years Recurrent prolapse-anatomic | 7-10 years post-operative | Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 Year composite score | 1 year post-operative | Failure of prolapse surgery as measured as a composite outcome including anatomic failure measured by changes to Aa and Ba points to -1 or greater, yes to PFDI question #3, and retreatment with pessary or surgery for anterior compartment prolapse |
| 7-10 years composite score | 7-10 years post-operative | Failure of prolapse surgery as measured as a composite outcome including anatomic failure measured by changes to Aa and Ba points to -1 or greater, yes to PFDI question #3, and retreatment with pessary or surgery for anterior compartment prolapse |
Outcome results
None listed