Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?

The objective is to explore the genetic predisposition to early pelvic organ prolapse after adequate surgical repair by exploring the association between pelvic organ prolapse recurrences and certain polymorphisms.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse

Detailed Description

Pelvic organ prolapse develops as a result of a loss of support provided by the muscles and fascia that constitute the pelvic floor. Several recent population studies have estimated the prevalence of pelvic organ prolapse at between 10% and 30%. One in nine women will undergo surgery for these disorders in her lifetime and of these, one third will undergo repeated surgeries. The correction of pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patients quality of life. There are a few studies that have explored the genetic predisposition to developing pelvic organ prolapse but none so far looks at genetic factors involved in prolapse recurrence after adequate prolapse repair. There are two groups of women: women who underwent adequate repair of their prolapse and had an unexplained early recurrence. And a second control group of women who underwent the same prolapse repair procedure and had no further prolapse recurrence.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women suffering from pelvic organ prolapse

Description

Inclusion Criteria:

• Cases: early, unexplained recurrence (within 6 months of procedure) after sacrocolpopexy), the recurrence required treatment (surgery or pessary) Controls: sacrocolpopexy during the same period, no recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)

Exclusion Criteria:

• Obvious surgical technical failure
• Use of other graft material than polypropylene mesh
• Planned two staged operation
• Contraindications to surgery based on existing medical conditions
• Pregnancy
• Desire for pregnancy in the future

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cases; Early, unexplained recurrence (within six months of procedure) after Sacrocolpopexy; The recurrence required treatment (surgery or pessary)
Controls; Sacrocolpopexy during the same period; No recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNP microarray analysis from recurrent prolapse subjects and controls	DNA will be evaluated by a variety of methods. For example, candidate polymorphisms may be evaluated using TaqMan SNP allelic discrimination assays which are based upon duplex real-time PCR. In addition, genome-wide SNP microarrays may be employed in order to perform a whole genome association study. Additional analysis such as DNA resequencing may also be required in order to identify causative polymorphisms linked to the newly associated SNPs. Other methods of DNA analysis such as next-generation sequencing may also be warranted.	12 months post-operative, DNA will be collected

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare all peri-operative characteristics and demographics between groups	Perioperative data will include: age, date of surgery, repeat procedure or treatment, procedure and mesh used, mesh related complications, early post-operative complications. Descriptive statistics will be derived for the entire group. The two subgroups (case and control) will then be compared using: Student t test, Fisher exact test, and Wilcoxon rank-sum test for continuous, nonparametric categorical and nonparametric ordinal variables, respectively.	12 months post-operative

Collaborators and Investigators

• Sponsor: Atlantic Health System
• Collaborators: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Charbel Salamon, MD, Atlantic Health System; Principal Investigator: Richard Scott, MD, Reproductive Medicine Associates

Publications and helpful links

General Publications

• St Louis S, Scott R, Lewis C, Salamon C, Pagnillo J, Treff N, Taylor D, Culligan P. Genetic Mutation that May Contribute to Failure of Prolapse Surgery in White Women: A Case-Control Study. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):726-30. doi: 10.1016/j.jmig.2016.02.019. Epub 2016 Mar 2.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: DNA; reoperation; next-generation sequencing; pelvic organ prolapse; pelvic floor; polymorphisms; genetic predisposition; genetic factors; recurrence of pelvic organ prolapse; SNP microarray analysis; adequate prolapse repair; surgical failure; buccal swabs; TaqMan SNP allelic discriminiation assays; duplex real-time PCR; genome-wide SNP microarrays
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Recurrence; Prolapse; Pelvic Organ Prolapse; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: R11-10-004