ArticleSexual medicine2021
The ThermiVa In Genital Hiatus Treatment (TIGHT) Study.
Article in Sexual medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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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
3 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Patient-reported outcomes and measures for vaginal relaxation syndrome management: a systematic review.Health and quality of life outcomes · 2025Pooled it
- 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
Corrections and comments
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Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionVaginal laxity or the sensation of vaginal looseness affects anywhere from 24% to 50% of postpartum women.
aimTo evaluate the efficacy and safety of the ThermiVa (ThermiAesthetics, TX, USA) monopolar radiofrequency device in the treatment of vulvovaginal laxity and sexual dysfunction
methodsThe TIGHT study was a prospective single blinded randomized sham-control trial conducted over 3 sites in Australia and India. The study included parous woman over the age of 18 who complained of vaginal laxity/looseness. Participants were randomized into a treatment group and a sham group. Patients in the treatment group were treated with an active probe, whereas, women in the placebo group were treated with sham probes that only reached subtherapeutic temperatures.
main outcome measuresSubjective success was determined by improvement in the Female Sexual Function Index (FSFI), Vaginal Laxity Questionnaire (VLQ), Vaginal Flatus Score (VFS), and the Vaginal laxity Bother Score (VLBS). Objective success was measured via the Modified Oxford Score (MOS) and Genital Hiatus (GH) length.
resultsSixty-three participants were recruited (sham n = 29, treatment n = 34). In the treatment group, FSFI scores improved at 3 months (mean difference 8-points, P value .02), and at 6 months (mean difference 5-points, P value .07). At baseline 89.7% and 87.2% of patients in the sham and treatment groups, respectively, classified themselves as "loose" on the VLQ. At 6 months 73.1% of patients in the sham group still identified as "loose" compared to 32.4% of patients in the active group (P value .01). Subjective success was also noted in the VLBS (P value .02). Results pertaining to VLFS, MOS, and GH did not reveal statistically significant results.
conclusionTreatment with ThermiVa was associated with a modest subjective improvement in vaginal laxity and sexual dysfunction and proved to be safe over the 6-month trial period. Pather K, Dilgir S, Rane A. The ThermiVa In Genital Hiatus Treatment (TIGHT) Study. Sex Med 2021;9:100427.
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