Open Pilot Study on the Rejuvenation Effect of Absorbable Threads in the Genital Area

Abstract

Purpose

We propose a new method of genital rejuvenation based on absorbable thread insertion. In this study, we aimed to assess the safety and efficacy of particular absorbable threads made of P (LA/CL), the so-called Nano Spring 7, for vulvar rejuvenation.

Patients and Methods

The study was conducted in two parts: the first by anatomical dissection and the second by clinical study. The first part of the study clarified safety and efficacy of thread insertion in this anatomical area. During the second part, 19 patients underwent Nano Spring 7 absorbable thread insertion in the subcutaneous layer of the labia majora to improve esthetic parameters and were followed up after 7, 30, 90, and 180 days. We evaluated outcomes using four different patients’ questionnaires and one investigator’s questionnaire.

Results

The anatomical dissection defined the correct anatomical layer of threads implantation and the subcutaneous structures allowing for the thread anchoring. All the patients completed the study. The patients’ and investigators’ subjective evaluations during follow-up and at the end of the study were very positive. All the patients showed a decrease in discomfort sensations related to the labia majora conditions and aesthetic improvement in the vulvar area and recommended the treatment to their friends.

Conclusion

The use of absorbable threads is an innovative, safe minimally invasive approach to genital rejuvenation.

Keywords:

• genital rejuvenation
• threads in polylactic acid
• non-surgical rejuvenation
• threads in spring shape

Data Sharing Statement

The data are available on request from corresponding author.

Ethics Statement

The cadaver dissection study was approved by the Ethical Committee of the Faculty of Medicine of the Comenius University in Bratislava. All rights to research and its results are reserved. The study was accompanied by compliance with all legal aspects of the use of cadaveric material. The clinical study has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

Consent Statement

All persons gave their informed consent prior to their inclusion in the study.

Acknowledgments

Dr. Eliška Kubíková, PhD Surgeon, Professor from the Department of Anatomy, Medical Faculty, Comenius University in Bratislava technically performed anatomical dissections in the first part of the study. This paper was presented at the XVI Kolkhida Congress 2022 (Tbilisi, Georgia) as a presentation with interim findings. The abstract was not published in any digital platform/abstract book.

Disclosure

Dr. Irina Poleva is an Aptos company (manufacturer of NS/ threads) trainer. Dr. Natalia Markova is an Aptos company trainer. Dr. Marlen Sulamanidze is the inventor of Aptos technology and co-owner of Aptos company.

Additional information

Funding

No funding was received for this study.