Pelvic organ prolapse, a group of related support defects of the female pelvic viscera, has reached endemic prevalence causing a significant impact on the quality of life of effected women. In the past, treatment success has been judged by anatomical outcomes. Recently symptom relief has been recognized as a more logical outcome measure, but treatment planning is still hampered by the number of treatment options and the lack of scientific evidence defining how well the various modalities relieve associated symptoms. Pessaries are the most commonly used nonsurgical treatment, but are under utilized in favor of surgery. Surgical intervention is obfuscated by controversy about which of several surgical techniques is most effective. Since normal pelvic organ support includes both connective tissue support as well as the support of the pelvic musculature, exercises to strengthen the pelvic muscles could be effective treatment either alone or in combination with other treatment modalities, yet there is a paucity of data describing this approach. Prior investigations of all treatments have applied the treatment without distinction to different patient characteristics, including stage of prolapse, site of prolapse, pelvic muscle strength, and patient demographics. Our hypothesis is that different subgroups of women with prolapse o the posterior vaginal wall will have better symptom relief from different therapies. Answering this hypothesis permit the creation of a clinical pathway for the optimal treatment of posterior vaginal prolapse. This will be accomplished through a multi-centered longitudinal cohort study with two nested randomized trials. Subjects be enlisted from the population of women with symptomatic posterior vaginal prolapse. Following enrollment, subjects will be randomized with respect to pelvic muscle exercises. Regardless of which pelvic muscle exercise arm they enter, subjects will be fitted with a ring pessary with support. They will also be offered surgery as an alternative therapy at any time if they are not satisfied with the pessary. Those that opt for surgical repair will be randomized to receive one of three surgical procedures, the posterior colpoperineorrhaphy, defect-directed repair, or posterior fascial replacement. All subjects will be followed for a total of three years.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD041268-02
Application #
6536435
Study Section
Special Emphasis Panel (ZHD1-DRG-D (13))
Program Officer
Weber, Anne M
Project Start
2001-09-07
Project End
2006-06-30
Budget Start
2002-07-01
Budget End
2003-06-30
Support Year
2
Fiscal Year
2002
Total Cost
$651,087
Indirect Cost
Name
Johns Hopkins University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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