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Randomized Controlled Trial
. 2021 Apr;32(4):809-818.
doi: 10.1007/s00192-020-04511-1. Epub 2020 Sep 1.

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

Pamela A Moalli  1   2 , Shaniel T Bowen  3 , Steven D Abramowitch  3 , Mark E Lockhart  4 , Michael Ham  5 , Michael Hahn  6 , Alison C Weidner  7 , Holly E Richter  8 , Charles R Rardin  9 , Yuko M Komesu  10 , Heidi S Harvie  11 , Beri M Ridgeway  12 , Donna Mazloomdoost  13 , Amanda Shaffer  5 , Marie G Gantz  5 ; NICHD Pelvic Floor Disorders Network
Affiliations
Randomized Controlled Trial

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

Pamela A Moalli et al. Int Urogynecol J. 2021 Apr.

Abstract

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.

Keywords: Hysteropexy; MRI; Pelvic organ prolapse; Prolapse surgery; Transvaginal mesh; Vaginal hysterectomy.

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Conflict of interest statement

DISCLOSURES:

Pamela A. Moalli: Amphora Medical Inc, consulting; NICHD, research support;

Shaniel T. Bowen: None

Steven D. Abramowitch: NICHD: research support;

Mark E. Lockhart: JUM, deputy editor, salary and editorial work; Elsevier, book royalties; Oxford Publishers, book royalties;

Michael Ham: None

Michael E. Hahn: General Electric, research grant; HealthLytix, consultant;

Alison C. Weidner: OBGYN Survey, assistant editor, salary and editorial work; NICHD, research support; Urocure, consultant.

Holly E. Richter: IUJ, OG, editorial work and travel reimbursement; Worldwide Fistula Fund, board membership and travel reimbursement; American Urogynecologic Society, Board of Directors, travel reimbursement; Bluewind, DSMB; Renovia, Allergan, NICHD, NIA, research support; UpToDate, licensor and royalties;

Charles R. Rardin: FPMRS, editorial board membership; Solace Therapeutics, Pelvalon, Foundation for Female Health Awareness, NICHD, research support;

Yuko M. Komesu: Cook-Myosite®, funding; NICHD, funding

Heidi S. Harvie: None

Beri M. Ridgeway: Coloplast Corp, consulting, education, and travel & lodging;

Donna Mazloomdoost: Boston Scientific, research grant

Amanda Shaffer: None

Marie G. Gantz: Boston Scientific, research grant

Figures

Figure 1.
Figure 1.
Diagram of participant flow and data analysis.
Figure 2.
Figure 2.
Two transvaginal surgical procedures compared in DEMAND. Left: vaginal hysterectomy with uterosacral ligament suspension. Right: vaginal mesh (sacrospinous) hysteropexy with Uphold Lite device.
Figure 3.
Figure 3.
Establishment of the 3D pelvic coordinate system: (a) axial T2-weighted MRI scan showing right ischial spine (RIS), left ischial spine (LIS), and origin (O) points that define the x-axis; (b) midsagittal MRI scan showing points A, determined by one-third the major axis (pink line) of the pubic symphysis ellipse (dotted white line), and O that delineate the y-axis; (c) 3D view illustrating coordinate system with respect to the bony pelvis. The “true midsagittal plane” (yellow region) is given by the y-z plane of the pelvic coordinate system.
Figure 4.
Figure 4.
Comparisons in vaginal contours and anatomic measures between rest vs strain (left) and rest vs recovery (right) with respect to the Y (green) and Z axes (blue) of the 3D pelvic coordinate system. Outlines of the anterior vaginal wall (red contour) and posterior vaginal wall (cyan contour) are displayed.
Figure 5.
Figure 5.
Visualization of the vaginal position and orientation with respect to the Y (green) and Z axes (blue) of the 3D pelvic coordinate system. Left: anterior hymenal remnant (point A), halfway point of the anterior vaginal wall (point B), vaginal apex (point C), halfway point of the posterior vaginal wall (point D), and posterior hymenal remnant (point E) are identified along the vaginal contour. The distance between the hymenal remnants (dotted line AE) and halfway points (dotted line BD) are also displayed. Right: vaginal apex (point C) and midpoints of the i) hymenal remnants (point MAE) and ii) halfway marks (point MBD) delineate the upper axis (orange line) and lower axis (purple line) of the vagina.
See this image and copyright information in PMC

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