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

Atlantic Health System

Status: Completed

Conditions: Pelvic Organ Prolapse

Study type: Observational

Funder types: Other

Identifiers

NCT01614587

R11-10-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Cases

Description:

1. Early, unexplained recurrence (within six months of procedure) after Sacrocolpopexy 2. The recurrence required treatment (surgery or pessary)

Controls

Description:

1. Sacrocolpopexy during the same period 2. No recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)