Trial reportJournal of women's health (2002)2018
Effect of Single-Session, Cryogen-Cooled Monopolar Radiofrequency Therapy on Sexual Function in Women with Vaginal Laxity: The VIVEVE I Trial.
Trial report in Journal of women's health (2002), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 7 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 7 syntheses or guidelines pooled it, 63 citations in OpenAlex.
- Patient-reported outcomes and measures for vaginal relaxation syndrome management: a systematic review.Health and quality of life outcomes · 2025Pooled it
- Mindfulness-based interventions for addressing sexual function after cancer: A systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Pooled it
- Vaginal lasers for treating stress urinary incontinence in women.The Cochrane database of systematic reviews · 2025Pooled it
- High Versus Low Ligation of the Inferior Mesenteric Artery in Colorectal Cancer Surgery: A Systematic Review and Meta-Analysis.Medicina (Kaunas, Lithuania) · 2022Pooled it
- A systematic review and meta-analysis of risks and benefits with breast reduction in the public healthcare system: priorities for further research.BMC surgery · 2021Pooled it
- Cosmetic gynecology-a systematic review and call for standardized outcome measures.International urogynecology journal · 2020Pooled it
- The Clinical Role of LASER for Vulvar and Vaginal Treatments in Gynecology and Female Urology: An ICS/ISSVD Best Practice Consensus Document.Journal of lower genital tract disease · 2019Pooled it
- Trial
- Effect of breathing exercises on depression, sexual function, and exercise capacity in postmenopausal women: a randomized controlled trial.Scientific reports · 2026Trial
- Early Feasibility Study to Evaluate the Viveve System for Female Stress Urinary Incontinence: Interim 6-Month Report.Journal of women's health (2002) · 2020Trial
- Article
- Efficacy and Safety of Radiofrequency as a Treatment Modality for Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.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
- Chapter 4.5: New Proposed Treatments for Pelvic Organ Prolapse.International urogynecology journal · 2026Review
- Article
- Prevalence of vaginal laxity in primiparous women six months after birth.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2025Article
- Bipolar Radiofrequency and Non-Crosslinked Hyaluronic Acid Plus Calcium Hydroxyapatite in the Treatment of Stress Urinary Incontinence.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Effect of vitamin D vaginal suppository on sexual functioning among postmenopausal women: A three-arm randomized controlled clinical trial.Obstetrics & gynecology science · 2023Article
- The Effect of Radiofrequency Therapy on Sexual Function in Female Cancer Survivors (Gynecologic and Breast) and Non-cancer Menopausal Women: A Single-Arm Trial.Journal of lasers in medical sciences · 2023Article
- Hyaluronic Acid and Radiofrequency in Patients with Urogenital Atrophy and Vaginal Laxity.Pharmaceuticals (Basel, Switzerland) · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis subanalysis of the VIVEVE I trial aimed to evaluate the impact of cryogen-cooled monopolar radiofrequency (CMRF) therapy, for the treatment of vaginal laxity, on the domains of sexual function included in the Female Sexual Function Index (FSFI). MATERIALS AND
methodsThe VIVEVE I clinical trial was prospective, randomized, single-blind, and Sham-controlled. Nine clinical study centers in Canada, Italy, Spain, and Japan were included. This subanalysis included premenopausal women with self-reported vaginal laxity who had ≥1 term vaginal delivery and a baseline FSFI total score ≤26.5, indicating sexual dysfunction. Enrolled subjects were randomized (2:1) to receive CMRF therapy [Active (90 J/cm
resultsSubjects randomized to Active treatment (n = 73) had greater improvement than Sham subjects (n = 35) on all FSFI domains of sexual function at 6 months postintervention. The analysis of covariance change from baseline analyses showed statistically significant improvements, in favor of Active treatment, for sexual arousal (p = 0.004), lubrication (p = 0.04), and orgasm (p = 0.007). In addition, Active treatment was associated with clinically important and statistically significant improvements in sexual desire [Odds ratio (OR) = 3.01 (1.11-8.17)], arousal [OR = 2.73 (1.06-7.04)], and orgasm [OR = 2.58 (1.08-6.18)].
conclusionsThis subanalysis showed CMRF therapy is associated with statistically significant and clinically important improvements in sexual function in women with vaginal laxity. These findings provide the first randomized, placebo-controlled energy-based device evidence for functional improvements associated with a nonsurgical modality for a highly prevalent and undertreated condition.
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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.