Anterior Prolapse Repair With and Without Graft Augmentation

Pelvic Organ Prolapse Clinical Trial

— ARCUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085952
• Other study ID #: EH04-302
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: January 2016

Study information

• Verified date: September 2019
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2016
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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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Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• dermal graft (ARCUS repliform) for anterior colporrhaphy
At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation
• suture based anterior colporrhaphy
At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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