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



Status:Completed
Conditions:Other Indications, Women's Studies
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:Any
Updated:6/10/2017
Start Date:March 2012
End Date:April 2015

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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.

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
We found this trial at
1
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Morristown, New Jersey 07960
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Morristown, NJ
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