Anterior Prolapse Repair With and Without Graft Augmentation (ARCUS)

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: dermal graft (ARCUS repliform) for anterior colporrhaphy; Procedure: suture based anterior colporrhaphy

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).

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: Any patient planning to undergo surgery for anterior compartment prolapse, English speaking.

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Exclusion Criteria: Any patient who does not speak English due to standardized English language based questionaires, and patients without anterior compartment prolapse.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anterior colporrhaphy with dermal graft; 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; At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation
Active Comparator: anterior colporrhaphy suture based; 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; At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Investigators: Principal Investigator: Peter Sand, MD, North Shore Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: pelvic organ prolapse, vaginal graft
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: EH04-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No