Comprehensive Evaluation of Prolapse Meshes by an Interdisciplinary Research Team

跨学科研究团队对脱垂网片的综合评估

• 批准号: 8472506
• 负责人: Pamela A. Moalli
• 金额: $ 34.68万
• 依托单位: MAGEE-WOMEN'S RES INST AND FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-15 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8472506
• 关键词: Abdomen; Abdominal Surgical Procedures; Acute; Address; Adrenergic Antagonists; Adult; Age; Agonist; Anatomy; Applications Grants; Autologous; Behavior; Biochemical; Biocompatible Materials; Biological; Biological Assay; Biomechanics; Biomedical Engineering; Chronic; Clinical; Clinical Data; Collagen; Connective Tissue; Data; Deterioration; Development; Dyspareunia; Elasticity; Elastin; Estrogens; Evaluation; Extracellular Matrix; Failure; Foundations; Funding Mechanisms; Future; Goals; Gold; Grant; Health; Human; Hysterectomy; Immune response; Implant; Incidence; Infection; Inferior; Institutes; Institution; Integration Host Factors; Interdisciplinary Study; Lead; Length; Maintenance; Marketing; Mechanics; Mentors; Methods; Modeling; Morbidity - disease rate; Muscarinics; Muscle function; Occupations; Operative Surgical Procedures; Organ; Outcome; Pain; Patients; Pelvis; Phase; Physiological; Plague; Polypropylenes; Procedures; Process; Progesterone; Property; Protocols documentation; Ptosis; Public Health; Recommendation; Relative (related person); Reproductive Physiology; Scientist; Sheep; Smooth Muscle; Structure; Surgeon; Surgical incisions; Techniques; Tensile Strength; Testing; Textiles; Tissues; Transplanted tissue; Vagina; Vaginal Discharge; Vaginal Prolapses; Vaginal delivery procedure; Vendor; Woman; Women' s Health; abstracting; base; bladder pain; experience; falls; graduate student; implantation; improved; in vivo; mechanical behavior; multidisciplinary; nerve supply; next generation; nonhuman primate; rectal; regenerative; repaired; response; scaffold; soft tissue; success; tissue regeneration; tissue repair

Project Summary/Abstract: Comprehensive Evaluation of Prolapse Meshes by an Interdisciplinary Research Team Each year roughly 200,000 U.S. women undergo a surgery to repair pelvic organ prolapse (6, 7). Biologic and synthetic meshes are widely used in prolapse repairs to improve anatomical outcomes over native tissue repairs which currently have a failure rate of over 30%. To date, however, there is little scientific data to guide surgeons in the selection of a particular product. As a result, meshes are used based on the recommendations of a local vendor and consequently, are placed in women on a trial and error basis. There is growing evidence, however, that the complications associated with prolapse meshes cause unacceptably high rates of morbidity including infection, mesh shrinkage, mesh erosion, mesh exposure, pelvic, rectal and bladder pain and dyspareunia. Such complications have become significant enough for the FDA to recently release a warning about mesh use, especially when it is placed transvaginally. In this proposal, we therefore, aim to establish an interdisciplinary team of scientists dedicated to the comprehensive testing of previously or newly marketed prolapse meshes and for the development of the next generation of graft materials based on specific scientific criteria. In the first phase of the study, we determine how biochemical and structural changes in the prolapsed vagina impact passive and active mechanical behavior so as to develop a mesh in which these deficiencies are repaired or compensated for, allowing us to restore the prolapsed vagina to the nonprolapsed condition. In the second phase, we hypothesize that the shortcoming of current prolapse meshes is that they are too stiff. While this results in a repair with increased tensile strength, it occurs at the expense of tissue function with accelerated tissue contraction, decreased elasticity and compliance, and deterioration of smooth muscle function. To test our hypothesis, we implant commonly used synthetic prolapse meshes into the vagina of nonhuman primates with prolapse using the gold standard surgical procedure (the abdominal sacrocolpopexy) and then define the cellular, biochemical and biomechanical impact on the vagina at 6 months post implantation. Eventually, we will implant meshes transvaginally to characterize the distinct host response to this surgical approach. In the third phase, we explore the development of future grafts for prolapse surgery. We hypothesize that because of its bioinductive effects, a combined biologic/synthetic mesh will be superior to a synthetic mesh alone in restoring vaginal structure and function. We propose that a key yet poorly developed component of prolapse repairs is the re- establishment of smooth muscle reactivity and therefore, test the use of a temporary biologically active scaffold in achieving this process. In this way, this grant proposal provides a mechanism to establish the first team of scientists dedicated to the comprehensive unbiased evaluation of prolapse meshes as a means of educating both current and future prolapse surgeons, and the public regarding potential problems associated with certain materials. Indeed, the development of such a group is imperative for protecting the health of women.

项目总结/文摘:

项目成果

Deterioration in biomechanical properties of the vagina following implantation of a high-stiffness prolapse mesh.

• DOI: 10.1111/1471-0528.12077
• 发表时间: 2013-01
• 期刊: BJOG : an international journal of obstetrics and gynaecology
• 作者: Feola A;Abramowitch S;Jallah Z;Stein S;Barone W;Palcsey S;Moalli P
• 通讯作者: Moalli P

Vaginal degeneration following implantation of synthetic mesh with increased stiffness.

• DOI: 10.1111/1471-0528.12085
• 发表时间: 2013-01
• 期刊: BJOG : an international journal of obstetrics and gynaecology
• 作者: Liang R;Abramowitch S;Knight K;Palcsey S;Nolfi A;Feola A;Stein S;Moalli PA
• 通讯作者: Moalli PA

Impact of prolapse meshes on the metabolism of vaginal extracellular matrix in rhesus macaque.

脱垂网络对恒河猕猴阴道细胞外基质代谢的影响。

• DOI: 10.1016/j.ajog.2014.08.008
• 发表时间: 2015-02
• 期刊: AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
• 影响因子: 9.8
• 作者: Liang, Rui;Zong, Wenjun;Palcsey, Stacy;Abramowitch, Steven;Moalli, Pamela A.
• 通讯作者: Moalli, Pamela A.

Extracellular matrix regenerative graft attenuates the negative impact of polypropylene prolapse mesh on vagina in rhesus macaque.

• DOI: 10.1016/j.ajog.2016.09.073
• 发表时间: 2017-02
• 期刊: American journal of obstetrics and gynecology
• 影响因子: 9.8
• 作者: Liang R;Knight K;Barone W;Powers RW;Nolfi A;Palcsey S;Abramowitch S;Moalli PA
• 通讯作者: Moalli PA

Towards rebuilding vaginal support utilizing an extracellular matrix bioscaffold.

• DOI: 10.1016/j.actbio.2017.05.015
• 发表时间: 2017-07-15
• 期刊: Acta biomaterialia
• 影响因子: 9.7
• 作者: Liang R;Knight K;Easley D;Palcsey S;Abramowitch S;Moalli PA
• 通讯作者: Moalli PA