Pelvic Organ Prolapse
Conditions
Keywords
pelvic organ prolapse, recurrence of pelvic organ prolapse, genetic predisposition, SNP microarray analysis, pelvic floor, genetic factors, adequate prolapse repair, polymorphisms, surgical failure, reoperation, DNA, buccal swabs, TaqMan SNP allelic discriminiation assays, duplex real-time PCR, genome-wide SNP microarrays, next-generation sequencing
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.
Interventions
None listed
Sponsors
Reproductive Medicine Associates of New Jersey
Atlantic Health System
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed