Level C· Early human research exploring benefitsCohort StudyPubMed

A new approach to regenerative medicine in gynecology.

Mantovani M., Gennai A., Russo PR.

Cohort Study with a reported sample of 12 on Scar, published in Int J Gynaecol Obstet (2021) — summary generated from the PubMed abstract.

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Level C· Early human research exploring benefitsEvidence level of this study

Early human evidence such as case series or small samples is exploring possible benefits.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
Read the A–D evidence level guide

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Cohort Study
Journal
Int J Gynaecol Obstet (2021)
Country
United States
Reported sample size
12
Source database
PubMed
PMID
34463351
DOI
10.1002/ijgo.13906
Citations
2

Abstract (original English)

To evaluate the efficacy of the injection of microfragmented adipose tissue in the treatment of women with genitourinary syndrome of menopause (GSM). This observational cohort study included 12 women who received one session of multiple injections of microfragmented adipose tissue using the SEFFIGYN ™ medical device. Symptoms such as burning, itching, dryness, pain on penetration, pain during deep intercourse, and pain on urination were assessed before the patient's treatment (T0), after 15 days (T15), and after 5 months (5Mo) using the Numerical Rating Scale (NRS). An improvement of vulvar trophism was clinically evident already 2 weeks after treatment; all symptoms were notably attenuated compared with the initial visit, as demonstrated by statistically significant reductions of the NRS scores (P = 0.003 for itching, P = 0.008 for pain on urination, and P < 0.001 for the other symptoms, Sign test). Moreover, all symptoms continued to improve over time. All patients reported a positive change in their quality of life and a resumption of sexual life. The use of microfragmented adipose tissue in GSM is promising. Nevertheless, more studies will be fundamental to exclude a potential placebo effect and better understand the underlying molecular mechanism of action.

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

How we grade evidence
FemaleGynecologyHumansMenopausePainPruritusQuality of LifeRegenerative MedicineVaginaVaginal Diseases

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