Materna Medical is committed to advancing women\u2019s 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\u2019s 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.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
https:\/\/clinicaltrials.gov\/study\/NCT03973281<\/a><\/p>\n 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.<\/p>\n Materna Prep Study Phase II (EASE)<\/p>\n https:\/\/clinicaltrials.gov\/study\/NCT02332759<\/a><\/p>\n 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\/<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div> Kingsberg S. Abstract 27019: An interim sub-analysis of nulliparous subjects in the POMPOM study evaluating the efficacy of the Milli Expanding Dilator as a treatment for achieving intercourse [abstract]. Presented at: ASRM 2025 Scientific Congress & Expo; 2025 Oct 25\u201329; San Antonio, TX. Abstract<\/a> | Slides<\/a><\/p>\n Kingsberg S. An interim menopause sub-analysis of the POMPOM study evaluating the efficacy of the Milli Expanding Dilator as a treatment for achieving intercourse [abstract]. Presented at: The Menopause Society Annual Meeting; 2025 Oct 21\u201325; Orlando, FL. Poster number: P-87. Abstract<\/a> | Poster<\/a> | Slides<\/a><\/p>\n Kingsberg S. A sub-analysis comparing subjects experienced with static dilators vs naive to dilation from the POMPOM study evaluating the efficacy of the Milli Expanding Dilator as a treatment for achieving intercourse [abstract]. Presented at: SMSNA 26th Annual Fall Scientific Meeting; 2025 Oct 19\u201322; Grapevine, TX. Abstract receipt number: 23056. Abstract<\/a> | Slides<\/a><\/p>\n Kingsberg S. POMPOM 3-mo Interim Report Measuring Effectiveness on Vaginismus and Dyspareunia Using a Novel Expanding Dilator [abstract]. In: NPWH Annual Conference; 2025 Oct 1\u20134; Las Vegas, NV. Abstract<\/a> | Poster<\/a><\/p>\n 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<\/a><\/p>\n<\/div><\/div><\/div> 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\u2019s preference or clinician directives.<\/p>\n\n
\nAbstract<\/a> | Poster<\/a><\/li>\n
\nhttps:\/\/www.clinbiomech.com\/article\/S0268-0033(25)00002-6\/abstract<\/a><\/li>\n
\nhttps:\/\/doi.org\/10.1007\/s00192-024-05904-2<\/a><\/li>\n
\ndoi: 10.1016\/j.ajog.2023.11.1253<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/i><\/i><\/span>Materna Prep Pilot Study \u2014 ClinicalTrials.gov ID NCT02332759<\/span><\/a><\/h3><\/div>
Milli Expanding Vaginal Dilator<\/span><\/span><\/h2><\/div>
<\/i><\/i><\/span>Prospective, On-Market, Patient-Reported Outcomes for Milli\u2122 Vaginal Dilator (POMPOM) Study \u2014 ClinicalTrials.gov ID 06397885<\/span><\/a><\/h3><\/div>
<\/i><\/i><\/span>Patient self-determination study<\/span><\/a><\/h3><\/div>
<\/i><\/i><\/span>Other Literature<\/span><\/a><\/h3><\/div>
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