ARCUS: Anterior Prolapse Repair With and Without Graft Augmentation

• Sponsor: NorthShore University HealthSystem (Other)
• Overall Status: Completed
• CT.gov ID: NCT04085952
• Collaborator: (none)
• Enrollment: 114
• Arms: 2
• Duration (Months): 132

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: dermal graft (ARCUS repliform) for anterior colporrhaphy; Procedure: suture based anterior colporrhaphy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing Anterior Prolapse Repair With and Without Allograft Use: A Randomized Control Trial With Long Term Follow-Up
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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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Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NorthShore University HealthSystem

Investigators

• Principal Investigator: Peter Sand, MD, North Shore Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NorthShore University HealthSystem
• ClinicalTrials.gov Identifier: NCT04085952
• Other Study ID Numbers: EH04-302
• First Posted: Sep 11, 2019
• Last Update Posted: Sep 11, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by NorthShore University HealthSystem: pelvic organ prolapse, vaginal graft
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Sep 11, 2019