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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614587
• Other study ID #: R11-10-004
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: June 8, 2017
• Start date: March 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2017
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition to Disease
• Pelvic Organ Prolapse
• Prolapse
• Recurrence

Locations

Country	Name	City	State
United States	Atlantic Health System	Morristown	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Atlantic Health System	Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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