Clinical trial NCT01614587: Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?
Official title: Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
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
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
Collaborators: name: Reproductive Medicine Associates of New Jersey
First posted: 2012-06-08
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women suffering from pelvic organ prolapse

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.

Eligibility criteria: 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

Primary outcomes:
measure: SNP microarray analysis from recurrent prolapse subjects and controls
timeFrame: 12 months post-operative, DNA will be collected
Secondary outcomes:
measure: Compare all peri-operative characteristics and demographics between groups
timeFrame: 12 months post-operative
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates
name: Richard Scott, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlantic Health System
name: Patrick Culligan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlantic Health System
name: Charbel Salamon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.