Methods for the defining mechanisms of anterior vaginal wall descent (DEMAND) study.

Autor: Moalli PA; Department of Obstetrics, Gynecology & Reproductive Sciences, Magee Women's Research Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. moalpa@upmc.edu.; Division of Urogynecology and Reconstructive Pelvic Surgery, Magee Women's Research Institute, Magee Women's Hospital of the University of Pittsburgh, 204 Craft Avenue, A320, Pittsburgh, PA, 15213, USA. moalpa@upmc.edu., Bowen ST; Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA., Abramowitch SD; Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA., Lockhart ME; Department of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA., Ham M; Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, Durham, NC, USA., Hahn M; Obstetrics, Gynecology, and Reproductive Sciences, UC San Diego Health, San Diego, CA, USA., Weidner AC; Duke University Medical Center, Durham, NC, USA., Richter HE; Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL, USA., Rardin CR; Alpert Medical School of Brown University, Providence, RI, USA., Komesu YM; University of New Mexico, Albuquerque, NM, USA., Harvie HS; Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA., Ridgeway BM; Division of Urogynecology, Cleveland Clinic, Cleveland, OH, USA., Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA., Shaffer A; Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, Durham, NC, USA., Gantz MG; Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, Durham, NC, USA.
Jazyk: angličtina
Zdroj: International urogynecology journal [Int Urogynecol J] 2021 Apr; Vol. 32 (4), pp. 809-818. Date of Electronic Publication: 2020 Sep 01.
DOI: 10.1007/s00192-020-04511-1
Abstrakt: Introduction and Hypothesis: The protocol and analysis methods for the Defining Mechanisms of Anterior Vaginal Wall Descent (DEMAND) study are presented. DEMAND was designed to identify mechanisms and contributors of prolapse recurrence after two transvaginal apical suspension procedures for uterovaginal prolapse.
Methods: DEMAND is a supplementary cohort study of a clinical trial in which women with uterovaginal prolapse randomized to (1) vaginal hysterectomy with uterosacral ligament suspension or (2) vaginal mesh hysteropexy underwent pelvic magnetic resonance imaging (MRI) at 30-42 months post-surgery. Standardized protocols have been developed to systematize MRI examinations across multiple sites and to improve reliability of MRI measurements. Anatomical failure, based on MRI, is defined as prolapse beyond the hymen. Anatomic measures from co-registered rest, maximal strain, and post-strain rest (recovery) sequences are obtained from the "true mid-sagittal" plane defined by a 3D pelvic coordinate system. The primary outcome is the mechanism of failure (apical descent versus anterior vaginal wall elongation). Secondary outcomes include displacement of the vaginal apex and perineal body and elongation of the anterior wall, posterior wall, perimeter, and introitus of the vagina between (1) rest and strain and (2) rest and recovery.
Results: Recruitment and MRI trials of 94 participants were completed by May 2018.
Conclusions: Methods papers which detail studies designed to evaluate anatomic outcomes of prolapse surgeries are few. We describe a systematic, standardized approach to define and quantitatively assess mechanisms of anatomic failure following prolapse repair. This study will provide a better understanding of how apical prolapse repairs fail anatomically.
Databáze: MEDLINE
Externí odkaz: