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

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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.

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Abbreviations

DEMAND:

Defining Mechanisms of Anterior Vaginal Wall Descent

MRI:

Magnetic resonance imaging

POP:

Pelvic organ prolapse

NTR:

Native tissue repair

VM:

Transvaginal mesh

POP-Q:

Pelvic Organ Prolapse Quantification

PFDN:

Pelvic Floor Disorders Network

SUPeR:

Study of Uterine Prolapse Procedures Randomized

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Acknowledgments

Personnel

The authors wish to acknowledge the following individuals from the following institutions: UC San Diego Health, San Diego, CA: Michael E. Albo, Marianna Alperin, Joann Columbo, Kimberly Ferrante, Kyle Herrala, Sherella Johnson, Anna C. Kirby, Emily S. Lukacz, Charles W. Nager, Erika Ruppert, Erika Wasenda. Kaiser Permanente-San Diego: Gouri B. Diwadkar, Keisha Y. Dyer, Linda M. Mackinnon, Shawn A. Menefee, Jasmine Tan-Kim, Gisselle Zazueta-Damian. Duke University Medical Center, Durham, NC: Cindy Amundsen, Robin Gilliam, Acacia Harris, Akira Hayes, Amie Kawasaki, Nicole Longoria, Shantae McLean, Mary Raynor, Nazema Siddiqui, Anthony G. Visco. University of Alabama at Birmingham, Dept. OB/GYN, Birmingham, AL: Alicia Ballard, Kathy Carter, David Ellington, Robert L. Holley, Alice Howell, Jill Hyde, Ryanne Johnson, Alyssa Long, Lisa Pair, Sunita Patel, Nancy Saxon, R. Edward Varner, Robin Willingham, Velria Willis, Tracey Wilson. Alpert Medical School of Brown University, Providence, RI: Cassandra Carberry, Samantha Douglas, B. Star Hampton, Nicole Korbly, Ann S. Meers, Deborah L. Myers, Vivian W. Sung, Elizabeth-Ann Viscione, Kyle Wohlrab. University of New Mexico: Karen Box, Sara Cichowski, Gena Dunivan, Peter Jeppson, Julia Middendorf, Rebecca G. Rogers. University of Pennsylvania, Philadelphia, PA: Lily Arya, Uduak Andy, Teresa Carney, Lorraine Flick, Michelle Kingslee, Ariana Smith, Donna Thompson. Magee-Women’s Hospital, Dept. of OB/GYN & Reproductive Sciences, Pittsburgh, PA: Kate Amodei, Michael Bonidie, Judy Gruss, Jerry Lowder, Karen Mislanovich, Jonathan Shepherd, Gary Sutkin, Halina M. Zyczynski. Cleveland Clinic Foundation, Cleveland, OH: Matthew Barber, Kathleen Dastoli, Maryori Edington, Annette Graham, Geetha Krishnan, Eric Jelovsek, Marie Fidela R. Paraiso, Ly Pung, Cecile Unger, Mark Walters. Northwest Texas Physician Group: Susan Meikle. Research Triangle International, Research Triangle Park, NC: Katrina Burson, Ben Carper, AnnaMarie Connelly, UNC, Tracey Davis, Tracey Grant, Emily Honeycutt, Kelly Koeller-Anna, Kendra Glass, James Pickett, Dennis Wallace, Ryan Whitworth.

Funding

This study was conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development-sponsored Pelvic Floor Disorders Network (PFDN Protocol: 24SP01). This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD054214, U10 HD041267, U10 HD041261, U10 HD069013, U10 HD069025, U10 HD069010, U10 HD069006, U10 HD054215, U01 HD069031) and the National Institutes of Health Office of Research on Women’s Health. Research training support was given by the National Institute of Biomedical Imaging and Bioengineering (5T32EB003392–13). Partial support for the PFDN DEMAND study is being supplied by Boston Scientific Corporation through a research grant to the Pelvic Floor Disorders Network Data Coordinating Center, RTI International. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Author information

Authors and Affiliations

  1. Department of Obstetrics, Gynecology & Reproductive Sciences, Magee Women’s Research Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA

    Pamela A. Moalli

  2. 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

    Pamela A. Moalli

  3. Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA

    Shaniel T. Bowen & Steven D. Abramowitch

  4. Department of Radiology, University of Alabama at Birmingham, Birmingham, AL, USA

    Mark E. Lockhart

  5. Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, Durham, NC, USA

    Michael Ham, Amanda Shaffer & Marie G. Gantz

  6. Obstetrics, Gynecology, and Reproductive Sciences, UC San Diego Health, San Diego, CA, USA

    Michael Hahn

  7. Duke University Medical Center, Durham, NC, USA

    Alison C. Weidner

  8. Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL, USA

    Holly E. Richter

  9. Alpert Medical School of Brown University, Providence, RI, USA

    Charles R. Rardin

  10. University of New Mexico, Albuquerque, NM, USA

    Yuko M. Komesu

  11. Division of Urogynecology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA

    Heidi S. Harvie

  12. Division of Urogynecology, Cleveland Clinic, Cleveland, OH, USA

    Beri M. Ridgeway

  13. Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA

    Donna Mazloomdoost

Authors
  1. Pamela A. Moalli
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  2. Shaniel T. Bowen
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  3. Steven D. Abramowitch
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  4. Mark E. Lockhart
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  5. Michael Ham
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  6. Michael Hahn
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  7. Alison C. Weidner
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  8. Holly E. Richter
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  9. Charles R. Rardin
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  10. Yuko M. Komesu
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  13. Donna Mazloomdoost
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  14. Amanda Shaffer
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  15. Marie G. Gantz
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Consortia

for the NICHD Pelvic Floor Disorders Network

Contributions

Moalli, Pamela A.: Protocol/project development, Data collection, Manuscript writing/editing.

Bowen, Shaniel T.: Data collection, Manuscript writing/editing.

Abramowitch, Steven D.: Protocol/project development, Data collection, Manuscript writing/editing.

Lockhart, Mark E.: Protocol/project development, Data collection, Manuscript writing/editing.

Ham, Michael: Data collection/management, Manuscript writing/editing.

Hahn, Michael: Protocol/project development, Data collection, Manuscript writing/editing.

Weidner, Alison C.: Protocol/project development, Data collection, Manuscript writing/editing.

Richter, Holly E.: Protocol/project development, Data collection, Manuscript writing/editing.

Rardin, Charles R.: Protocol/project development, Data collection, Manuscript writing/editing.

Komesu, Yuko M.: Protocol/project development, Data collection, Manuscript writing/editing.

Harvie, Heidi S.: Protocol/project development, Data collection, Manuscript writing/editing.

Ridgeway, Beri M.: Data collection/management, Manuscript writing/editing.

Mazloomdoost, Donna: Protocol/project development, Manuscript writing/editing.

Shaffer, Amanda: Data collection/management, Manuscript writing/editing.

Gantz, Marie G.: Protocol/project development, Data collection/management, Data analysis, Manuscript writing/editing

Corresponding author

Correspondence to Pamela A. Moalli.

Ethics declarations

Conflict of interest

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.

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Appendix 1

Appendix 1

The following is a direct excerpt of a supplementary file from the parent study (SUPeR Trial) [15] that detailed its inclusion and exclusion criteria which was adopted by the DEMAND study:

Inclusion criteria

  1. 1.

    Women aged 21 or older who have completed child-bearing

  2. 2.

    Prolapse beyond the hymen (defined as Ba, Bp, or C > 0 cm)

  3. 3.

    Uterine descent into at least the lower half of the vagina [defined as point C > -TVL/2)]

  4. 4.

    Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to ‘sensation of bulging’ or ‘something falling out’

  5. 5.

    Desires vaginal surgical treatment for uterovaginal prolapse

  6. 6.

    Available for up to 60-month follow-up

  7. 7.

    Amenorrhea for the past 12 months from either menopause or endometrial ablation

  8. 8.

    Not pregnant, not at risk for pregnancy, or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)

  9. 9.

    Eligible for no cervical cancer screening for at least 3 years

Exclusion criteria

  1. 1.

    Previous synthetic material (placed vaginally or abdominally) to augment POP repair

  2. 2.

    Known previous uterosacral or sacrospinous uterine suspension

  3. 3.

    Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess

  4. 4.

    Chronic pelvic pain

  5. 5.

    Pelvic radiation

  6. 6.

    Cervical elongation—defined as an expectation that the C point would be Stage 2 or greater postoperatively if a hysteropexy was performed. (Note: cervical shortening or trachelectomy is not an allowed intraoperative procedure within the hysteropexy treatment group).

  7. 7.

    Women at increased risk of cervical dysplasia requiring cervical cancer screening more often than every 3 years [e.g., HIV+ status, immunosuppression because of transplant related medications, Diethylstilbestrol (DES) exposure in utero, or previous treatment for cervical intraepithelial neoplasia (CIN)2, CIN3, or cancer]

  8. 8.

    Uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, endometrial cancer, or any uterine disease that precluded prolapse repair with uterine preservation in the opinion of the surgeon)

  9. 9.

    Indication for ovarian removal (adnexal mass, BRCA 1/2 positivity, family history of ovarian cancer)

  10. 10.

    Current condition of amenorrhea caused by exogenous sex steroids or hypothalamic conditions.

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Moalli, P.A., Bowen, S.T., Abramowitch, S.D. et al. Methods for the defining mechanisms of anterior vaginal wall descent (DEMAND) study. Int Urogynecol J 32, 809–818 (2021). https://doi.org/10.1007/s00192-020-04511-1

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