Materna’s Clinical Research

Materna Medical is committed to advancing women’s health through high-quality clinical research on expanding vaginal dilators. We utilize rigorous study designs to generate robust outcomes data. This is a comprehensive catalog of Materna’s registered clinical trials and associated peer-reviewed publications. All studies have been conducted within the United States. To ensure transparency and adherence to regulatory standards, Materna follows FDA guidelines and IRB-approved protocols.

Birth Device

https://clinicaltrials.gov/study/NCT03973281

The EASE study is a large, randomized, controlled trial conducted in 20 top US hospitals, aiming to evaluate whether an investigational device called the Ellora Obstetrical System (formerly known as the Materna Prep Device) can make childbirth safer and less likely to cause injury to one of the pelvic floor muscles.

Materna Prep Study Phase II (EASE)

  • Hesham H. Case Series: Ultrasound Follow-up of Complete Levator Ani Muscle (LAM) Avulsions in EASE Study Phase 2. Poster presented at: 2025 Annual Clinical Meeting of the Society of Obstetric and Gynecologic Hospitalists; September 13–17, 2025; Seattle, WA. Poster #23.
    Abstract | Poster
  • Masteling M, DeLancey JOL, Ashton-Miller JA. Two minutes is sufficient to characterize the viscoelastic properties of the human lower birth canal during the first stage of labor. Clin Biomech (Bristol). 2025 Feb;122:106430. doi: 10.1016/j.clinbiomech.2025.106430. Epub 2025 Jan 11. PMID: 39823697; PMCID: PMC11822253.
    https://www.clinbiomech.com/article/S0268-0033(25)00002-6/abstract
  • Hesham H, Orejuela F, Rood KM, Turrentine M, Casey B, Khandelwal M, Dajao R, Azad S, Rosen T, Hoffman MK, Wang EY, Hart L, Sheen JJ, Grisales T, Gibson KS, Torbenson V, Williams SF, Evantash E, Dietz HP, Wapner RJ. Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial. Int Urogynecol J. 2024 Sep;35(9):1839-1849. doi: 10.1007/s00192-024-05881-6. Epub 2024 Aug 3. PMID: 39096389; PMCID: PMC11420311. https://pubmed.ncbi.nlm.nih.gov/39096389/
  • Rusavy, Z. Commentary on “Effect of An Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial”. Int Urogynecol J 35, 1935–1936 (2024).
    https://doi.org/10.1007/s00192-024-05904-2
  • DeLancey JOL, Masteling M, Pipitone F, LaCross J, Mastrovito S, Ashton-Miller JA. Pelvic floor injury during vaginal birth is life-altering and preventable: what can we do about it? Am J Obstet Gynecol. 2024 Mar;230(3):279-294.e2. Epub 2024 Jan 2. PMID: 38168908; PMCID: PMC11177602.
    doi: 10.1016/j.ajog.2023.11.1253

https://clinicaltrials.gov/study/NCT02332759

Orejuela FJ, Gandhi R, Mack L, Lee W, Sangi-Haghpeykar H, Dietz HP, Ramin SM. Prospective evaluation of the safety and feasibility of a pelvic floor dilator during active labor. Int Urogynecol J. 2018 Oct;29(10):1485-1492. doi: 10.1007/s00192-018-3555-0. Epub 2018 Feb 6. PMID: 29411072. https://pubmed.ncbi.nlm.nih.gov/29411072/

Milli Expanding Vaginal Dilator

Kingsberg, S, Online Observational Clinical Trial for Assessing the Effectiveness of an FDA-Cleared Expanding Dilator. Presented at: ISSWSH/ISSM Joint Meeting 2025 Atlanta, GA February 27- March 2, 2025 [PDF accepted abstract and poster]. https://www.isswshmeeting.org/2025/program

Tucker, S., Javaid, S., & Rubin, R. (194) Accuracy of online patient self-diagnosis of vaginismus/genito-pelvic pain/penetration disorder (GPPPD), The Journal of Sexual Medicine, Volume 21, Issue Supplement_7, December 2024, qdae167.189, https://doi.org/10.1093/jsxmed/qdae167.189 [PDF accepted poster].

Milli was initially launched as a wellness product. The following publications reference data collected in a non-IRB approved initial pilot survey for the first expanding electronic vaginal trainer. Between November 2018-2019, more than 1,000 women were using the Milli Trainer, of which 335 opted to complete a 3-month follow-up survey questionnaire. The surveys were divided into four sections: customer background, protocols, outcome measures, and general customer satisfaction. Participants were not given a set universal direction on how to use or how often to use their Milli trainer and were using Milli to treat various conditions, leading to variation in usage depending on the user’s preference or clinician directives.

  • Gaddam NG, Kingsberg SA, Iglesia CB. Sexual Dysfunction and Dyspareunia in the Setting of the Genitourinary Syndrome of Menopause. Clin Obstet Gynecol. 2024 Mar 1;67(1):43-57. doi: 10.1097/GRF.0000000000000846. Epub 2023 Dec 6. PMID: 38281169.
  • Liu M, Juravic M, Mazza G, Krychman ML. Vaginal Dilators: Issues and Answers. Sex Med Rev. 2021 Apr;9(2):212-220. doi: 10.1016/j.sxmr.2019.11.005. Epub 2020 Jan 31. PMID: 32014450.
  • Krychman M, Kellogg-Spadt S, Prendergast S, Kingsberg S, Dweck A, Jurvic M. 056 The Milli™; the Only Patient Controlled Expanding Dilator: Follow Up Survey Experience. The Journal of Sexual Medicine. 2020 Jul 1;17(7):S245. https://academic.oup.com/jsm/article-abstract/17/Supplement_3/S245/7012358
  • Krychman, Michael MD; Juravic, Mark. The Final Design: Milli; Introducing the Only Patient Controlled Expanding Dilator [39F]. Obstetrics & Gynecology 131():p 74S, May 2018. DOI: 10.1097/01.AOG.0000533349.25751.08