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

NCT ID: NCT01614587

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-04-30

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

1. Early, unexplained recurrence (within six months of procedure) after Sacrocolpopexy

2. The recurrence required treatment (surgery or pessary)

No interventions assigned to this group

Controls

1. Sacrocolpopexy during the same period

2. No recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)

No interventions assigned to this group

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: collaborator

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medicine Associates

Patrick Culligan, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Charbel Salamon, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Locations

Atlantic Health System

Morristown, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26944198 (View on PubMed)

Other Identifiers

R11-10-004

Identifier Type: -

Identifier Source: org_study_id