We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614587
First Posted: June 8, 2012
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Reproductive Medicine Associates of New Jersey
Information provided by (Responsible Party):
Atlantic Health System
May 31, 2012
June 8, 2012
June 9, 2017
March 2012
April 2015   (Final data collection date for primary outcome measure)
SNP microarray analysis from recurrent prolapse subjects and controls [ Time Frame: 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.
SNP microarray analysis from recurrent prolapse subjects and controls [ Time Frame: 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 indentify causative polymorphisms linked to the newly associated SNPs. Other methods of DNA analysis such as next-generation sequencing may also be warranted.
Complete list of historical versions of study NCT01614587 on ClinicalTrials.gov Archive Site
Compare all peri-operative characteristics and demographics between groups [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?
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.
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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
DNA obtained from a buccal swab
Probability Sample
Women suffering from pelvic organ prolapse
Pelvic Organ Prolapse
Not Provided
  • Cases
    1. Early, unexplained recurrence (within six months of procedure) after Sacrocolpopexy
    2. The recurrence required treatment (surgery or pessary)
  • Controls
    1. Sacrocolpopexy during the same period
    2. No recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01614587
R11-10-004
Yes
Not Provided
Not Provided
Atlantic Health System
Atlantic Health System
Reproductive Medicine Associates of New Jersey
Principal Investigator: Richard Scott, MD Reproductive Medicine Associates
Principal Investigator: Patrick Culligan, MD Atlantic Health System
Principal Investigator: Charbel Salamon, MD Atlantic Health System
Atlantic Health System
June 2017