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Safety and Anatomic Efficacy of Transvaginal Prola ...
Safety and Anatomic Efficacy of Transvaginal Prolapse Repair Augmented with a Novel Decellularized Human Dermal Allograft - Nathan L. Guerette, MD
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This study aimed to evaluate the safety and effectiveness of transvaginal pelvic organ prolapse repair using a novel decellularized human dermal allograft (DHDA). A retrospective review was conducted on 44 patients who underwent anterior-apical and/or posterior-apical prolapse repair augmented with DHDA between March 2017 and January 2018. DHDA is processed using dCELL Technology to remove DNA content while maintaining an intact extracellular matrix (ECM) with key collagen proteins, vascular channels, proteoglycans, and glycosaminoglycans.<br /><br />The surgical technique involved reinforcing anterior or posterior colporrhaphy with DHDA configured to the patient's anatomy. The retrospective review considered patient demographics, intraoperative complications, postoperative adverse events, presence of bulge symptoms, anatomic efficacy, surgical satisfaction, and patient perception of improvement.<br /><br />At a mean follow-up of 10 months, there were no cases of anatomic failure in the target compartment. The presence of bulge symptoms was absent in all patients. Adverse events included de novo incontinence, dysuria, voiding dysfunction, fecal incontinence, constipation, and urinary urgency, but they were relatively low in occurrence. Patient satisfaction was high, with 91% reporting being "very satisfied" and 95% stating they would have the surgery again and recommend it to someone else. An examination revealed good anatomic durability, with no re-operations for anatomic failure.<br /><br />Based on the interim analysis, transvaginal pelvic organ prolapse repair augmented with DHDA was found to be safe and effective in achieving good anatomic durability, resolving bulge symptoms, and providing high patient satisfaction. This study contributes to the growing body of evidence supporting the use of DHDA in transvaginal prolapse repair.
Keywords
transvaginal pelvic organ prolapse repair
decellularized human dermal allograft
safety
effectiveness
retrospective review
anatomic durability
bulge symptoms
adverse events
patient satisfaction
surgical technique
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