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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Reproductive Medicine Associates of New Jersey
Information provided by (Responsible Party):
Jennifer Pagnillo, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01614587
First received: May 31, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • SNP microarray analysis from recurrent prolapse subjects and controls [ Time Frame: 12 months post-operative, DNA will be collected ] [ Designated as safety issue: No ]
    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:
  • Compare all peri-operative characteristics and demographics between groups [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

DNA obtained from a buccal swab


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women suffering from pelvic organ prolapse

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614587

Locations
United States, New Jersey
Atlantic Health System
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard Scott, MD Reproductive Medicine Associates
Principal Investigator: Patrick Culligan, MD Atlantic Health System
Principal Investigator: Charbel Salamon, MD Atlantic Health System
  More Information

No publications provided

Responsible Party: Jennifer Pagnillo, Charbel Salamon, MD. Director, Gynecologic Robotic Surgery, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01614587     History of Changes
Other Study ID Numbers: R11-10-004
Study First Received: May 31, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic Health System:
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

Additional relevant MeSH terms:
Disease Susceptibility
Prolapse
Recurrence
Genetic Predisposition to Disease
Pelvic Organ Prolapse
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014