Anterior Prolapse Repair With and Without Graft Augmentation

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: suture based anterior colporrhaphy; Procedure: dermal graft (ARCUS repliform) for anterior colporrhaphy

• Registration Number: NCT04085952
• Lead Sponsor: NorthShore University HealthSystem

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).

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2009-01
• Study Completion: 2016-01
• Study First Submitted: 2017-04-28
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Study First Posted: 2019-09-11
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterior colporrhaphy suture based	suture based anterior colporrhaphy	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.
anterior colporrhaphy with dermal graft	dermal graft (ARCUS repliform) for anterior colporrhaphy	Patients randomized to this arm underwent anterior colporrhaphy with dermal graft augmentation (ARUCS) during their surgery for pelvic organ prolapse.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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