Anterior Prolapse Repair With and Without Graft Augmentation

Study Overview
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Brief Summary
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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
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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).

Official Title
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Comparing Anterior Prolapse Repair With and Without Allograft Use: A Randomized Control Trial With Long Term Follow-Up

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: dermal graft (ARCUS repliform) for anterior colporrhaphy
* Procedure: suture based anterior colporrhaphy


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anterior colporrhaphy with dermal graft<br>Patients randomized to this arm underwent anterior colporrhaphy with dermal graft augmentation (ARUCS) during their surgery for pelvic organ prolapse. | Procedure: dermal graft (ARCUS repliform) for anterior colporrhaphy<br>* At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation<br>|
| Active Comparator: anterior colporrhaphy suture based<br>Patients randomized to this arm underwent anterior colporrhaphy with suture based repair (native tissue) during their surgery for pelvic organ prolapse. This is and was the most common practice for anterior colporrhaphy. | Procedure: suture based anterior colporrhaphy<br>* At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-Year Recurrent prolapse- anatomic | Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater | 1 year post-operative | 
| 7-10 Years Recurrent prolapse-anatomic | Failure of prolapse surgery as measured by changes in POPQ measurements, Aa and Ba to -1 or greater | 7-10 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 Year composite score | 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 | 1 year post-operative | 
| 7-10 years composite score | 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 post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse, vaginal graft