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Journals & Clinical Evidence

Journals & clinical evidence: Obstetrics & Gynaecology

Curated research to understand technology benefits, comparisons, and limitations, prioritizing studies that identify devices or brands in our portfolio.

5 publications · Obstetrics & Gynaecology

Brands in our portfolio2023 · Tantrakul V et al.

CPAP in high-risk pregnancy with OSA

Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial
Respiratory research

Open-label randomised trial · Three hospitals · 310 participants in the primary analysis

Findings: Diastolic blood pressure decreased by an average of 2.2 mmHg. Preeclampsia occurred in 13.1% of the CPAP group vs 22.3% with usual care.

Points to consider: 96.5% were recruited in the first trimester; this was not a trial of starting CPAP specifically in trimester III. Mean adherence was 2.5 hours/night. Findings apply to the high-risk OSA population studied.

Device & relevance: Philips Respironics REMstar Auto M / DreamStation named in the methods; the currently offered model needs to be matched.

DOI: 10.1186/s12931-023-02445-y

General clinical evidence2023 · Facco FL et al.

PAP in pregnancy: inconsistent findings

A trial of positive airway pressure for the treatment of sleep apnea in pregnancy
American journal of obstetrics & gynecology MFM

Randomised trial · 89 participants with OSA and obesity · Assessment at 28–31 weeks

Findings: There was no significant difference in the primary composite cardiometabolic risk outcome between treatment and control groups.

Points to consider: Treatment adherence was low; the control design changed between phases. Read this study alongside the Tantrakul trial, rather than selecting only positive findings.

Device & relevance: Brand/model match has not been verified.

DOI: 10.1016/j.ajogmf.2022.100840

Brand / device family2023 · Barba M et al.

LaEvita / LEONARDO: an early GSM study

Efficacy of a Diode Vaginal Laser in the Treatment of the Genitourinary Syndrome of Menopause
Bioengineering 10(10):1158

Prospective · 26 patients · No comparison group · Assessment one month after three monthly sessions

Findings: 19 of 26 patients (73.1%) reported improvement on PGI-I. Vaginal health and symptom scores improved; no adverse events were reported during this observation.

Points to consider: Small sample, no control or sham group, and short follow-up. It does not establish superiority to standard therapy, benefit for SUI, or long-term safety.

Device & relevance: LEONARDO Dual diode laser, Biolitec Italia, 980 + 1470 nm, named in the methods; the power variant needs to be matched.

DOI: 10.3390/bioengineering10101158

Brand / device family2024 · Vitale SG et al.

LEONARDO for GSM: follow-up to six months

Efficacy and Safety of Non-Ablative Dual Wavelength Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Single-Center Prospective Study
Advances in Therapy 41:4617–4627

Prospective pilot study · 22 postmenopausal women · Single centre · Three sessions · No control group

Findings: At six months, VHIS increased from 12 to 19.27. Vaginal dryness scores fell from 7.72 to 3.72; burning and dyspareunia also improved.

Points to consider: A small study without a comparator. Before–after results cannot separate intervention effects from other factors or establish superiority or long-term safety.

Device & relevance: The abstract names a LEONARDO dual-wavelength diode laser. The offered variant and configuration must be matched to the full publication.

DOI: 10.1007/s12325-024-03004-7

Procedure evidence · Other devices2021 · Bizjak-Ogrinc U, Senčar S

Laser labiaplasty: satisfaction and complications in a series of 80 patients

Sutureless Laser Labiaplasty of Labia Minora
Sexual Medicine 9:100406

Retrospective · 80 patients · No control group · Satisfaction assessed around day 60

Findings: 76 patients were very satisfied and four were satisfied. Seven wound infections, one bleeding event, and one haematoma were recorded.

Points to consider: Retrospective bias, no randomised comparator, and limited follow-up. This does not establish that laser is superior to other techniques.

Device & relevance: Er:YAG 2940 nm SP Dynamis (Fotona), not biolitec. Included as procedural context; it does not establish indications or outcomes for labiaplasty with LEONARDO.

DOI: 10.1016/j.esxm.2021.100406