Pelvic Organ Prolapse Studies

Pelvic organ prolapse is a term to describe the protrusion of the pelvic organs into or through the vaginal canal. This condition is usually due to direct or indirect damage to the vagina and its pelvic support system. The damage may be related to stretching or laceration of the vaginal wall, atrophy or injury of the nerves of the pelvic support structure. Oftentimes multiple defects will coexist. By the age of 80, the lifetime risk of a woman undergoing a single operation to treat specific defects in pelvic floor support, whether the conditions identified were pelvic organ prolapse alone, urinary incontinence alone, or both, has been estimated to be 11%.

In 1997, almost 226,000 women in the U.S. underwent surgery for pelvic organ prolapse. The treatment of pelvic organ prolapse has significantly evolved over the last few decades due to increased understanding of the anatomy as well as the development of minimally invasive surgeries. These procedures can now be done using general, regional or local anesthesia only.

Benefits to participating in the study: There may be no direct benefit to the subject as a result of participating in this study other than the information collected in this study may assist the investigator in treatment of the subject's condition. Additionally, the information collected during this study may benefit future subjects receiving devices for prolapse repair in refining surgical techniques and future products.

Study Rationale: Long-term evaluation of efficacy and safety of the devices for prolapse repair.

Subject Population: Female subjects who require surgical reconstruction of their pelvic floor due to genital prolapse.

Participants may be compensated for their time and travel costs.

If you think this is a research study you may be interested in, we invite you to contact our Research Nurses at 616-588-1134 or sign up for more information.