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

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT01614587
• Lead Sponsor: Atlantic Health System

Brief Summary

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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SNP microarray analysis from recurrent prolapse subjects and controls	12 months post-operative, DNA will be collected	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.

Secondary Outcome Measures

Name	Time	Method
Compare all peri-operative characteristics and demographics between groups	12 months post-operative	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.

Trial Locations

Locations (1)

Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States