Trial reportLasers in medical science2022
The efficacy and safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial.
Trial report in Lasers in medical science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Controlled Trial Comparing Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women
Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical Trial
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Patient-reported outcomes and measures for vaginal relaxation syndrome management: a systematic review.Health and quality of life outcomes · 2025Pooled it
- Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial.JAMA network open · 2023Trial
- The role of bipolar radiofrequency in the treatment of vaginal laxity: a single-center cohort study in premenopausal women.Lasers in medical science · 2026Observational
- Article
- Comparative Effectiveness of Conservative and Surgical Interventions for Vaginal Laxity: A Systematic Review and Pairwise Meta-Analysis.International urogynecology journal · 2026Review
- Efficacy and Safety of Energy-Based Device Therapy in Women Diagnosed with Vaginal Relaxation Syndrome: A Systematic Review and Meta-analysis.International urogynecology journal · 2026Review
- Radiofrequency technology as an anti-aging intervention: clinical efficacy in reversing senescence-driven skin laxity and age-related dermal degeneration.Frontiers in cell and developmental biology · 2026Article
- Application progress of radiofrequency (RF) therapy in pelvic floor disorders (PFDs): a narrative review focusing on randomized controlled trials.Gynecology and pelvic medicine · 2025Review
- Correlation Between Delivery Type and Pelvic Floor Dysfunction: A Case-Control Study.Advanced biomedical research · 2025Article
- Ultrasound imaging of core muscles activity in multiparous women with vaginal laxity: a cross-sectional study.Scientific reports · 2024Observational
- The efficacy and safety of temperature controlled dual-mode radiofrequency in women with vaginal laxity.BMC women's health · 2023Article
- Applicability of vaginal energy-based devices in urogynecology: evidence and controversy.Revista da Associacao Medica Brasileira (1992) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Non-invasive vaginal rejuvenation with radiofrequency (RF) and lasers devices have gained popularity, but well-designed studies confirming their effectiveness are lacking. The aim of this study was to compare the efficacy and safety of a multipolar RF and pulsed electromagnetic field-based device (PEMF) versus sham for vaginal laxity. Thirty-two premenopausal females with ≥ 1 vaginal delivery and self-reported vaginal laxity were randomized into 2 groups: active (RF + PEMF) and sham. Both groups received 3 vaginal treatments at 3-week interval. The Vaginal Laxity Questionnaire (VLQ), perineometer measurements, and Brink score were conducted at baseline, 4, and 12 weeks after treatments. Pre and post-treatment vaginal histology, Female Sexual Function Index (FSFI), subjects' satisfaction, pain, and adverse events were assessed. The active group VLQ scores increased and were significantly better than the sham group (p < 0.001). At the final follow-up, 50% of the active group reported no vaginal laxity (VLQ > 4) versus 12% in the sham group (p = 0.054). In the active group, all domains of perineometer measurements and Brink scores (p < 0.001), FSFI scores (p < 0.05), and patients' satisfaction (p < 0.001) were significantly increased and higher in the active group. Mild adverse effects including pain and burning sensation were not different between groups except for itch which was significantly higher in the sham arm (p = 0.014). Histology after RF + PEMF treatments demonstrated neocollagenesis, neoelastogenesis, and neoangiogenesis. In conclusion, combination RF + PEMF therapy was safe, improved vaginal laxity, strengthened pelvic floor muscles, and improved female sexual function for at least 12-week post-procedures with confirmed histological improvements. This study was registered on the Thai Clinical Trials Registry, TCTR20200803002 on 2020-07-30 "retrospectively registered."
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.