Is ThermiVa (radiofrequency vaginal rejuvenation) safe for treating vaginal laxity?

Is ThermiVa Safe for Vaginal Laxity?

ThermiVa (monopolar radiofrequency) appears to be safe for treating vaginal laxity based on available evidence, with no serious adverse events reported in clinical trials, though its efficacy is modest and inferior to pelvic floor muscle training at 6 months. 1, 2, 3

Safety Profile

The safety data for ThermiVa is reassuring across multiple studies:

• No adverse events were recorded in a 27-patient study evaluating monopolar radiofrequency for vulvovaginal laxity and stress urinary incontinence over a 6-month period 2
• The TIGHT randomized controlled trial (63 participants) demonstrated that treatment with ThermiVa proved to be safe over the 6-month trial period with no reported complications 1
• All subjects in clinical studies tolerated treatments well without adverse effects 2

Efficacy Considerations

While safe, the effectiveness of ThermiVa is limited and time-dependent:

Short-Term Results (30 Days)

• ThermiVa was noninferior to pelvic floor muscle training for improving sexual function scores at 30 days post-treatment 3
• Subjective improvement in vaginal laxity was reported, with patients' perception improving from "very loose" to "moderately tight" at 1-month follow-up 2

Long-Term Results (6 Months)

• ThermiVa was NOT noninferior to pelvic floor muscle training at 6 months, with better sustained results observed in the PFMT group 3
• In the TIGHT study, at 6 months, 32.4% of ThermiVa-treated patients still identified as "loose" compared to baseline 1
• The improvement in Female Sexual Function Index scores showed a mean difference of 8 points at 3 months (statistically significant, P=.02) but only 5 points at 6 months (P=.07, not statistically significant) 1

Clinical Algorithm for Vaginal Laxity Treatment

First-Line Treatment:

• Pelvic floor muscle training should be offered as the primary intervention, as it demonstrates superior long-term efficacy compared to radiofrequency devices 3
• Pelvic floor physical therapy improves sexual pain, arousal, lubrication, and satisfaction 4

Second-Line Treatment:

• ThermiVa can be considered for patients who fail or cannot comply with pelvic floor muscle training 3
• Typical treatment course consists of three once-weekly sessions, including intravaginal treatment followed by treatment of labia majora and perineum 2

Surgical Options:

• Colpoperineorrhaphy with levator ani myorrhaphy is associated with high success rates but carries risk of dyspareunia and should be reserved for cases with concurrent pelvic organ prolapse 5

Important Caveats

Limitations of Current Evidence

• Long-term effectiveness beyond 6 months remains unknown for radiofrequency treatments 5
• The TIGHT study showed no statistically significant objective improvements in Modified Oxford Score or genital hiatus measurements, despite subjective patient-reported improvements 1
• Success rates with radiofrequency appear lower than surgical treatments but with less invasiveness 5

What NOT to Recommend

• Vaginal laser therapy should not be used, as the FDA has not cleared these devices for menopausal symptoms and safety/effectiveness data are insufficient 6

Concurrent Symptom Management

If vaginal dryness or dyspareunia accompanies vaginal laxity:

• Start with vaginal moisturizers 3-5 times weekly and water-based lubricants during sexual activity 4
• Consider low-dose vaginal estrogen if non-hormonal options fail after 4-6 weeks 4
• Vaginal dilators may help with vaginismus or vaginal stenosis 4

Bottom Line

ThermiVa is safe but provides only modest, short-term subjective improvement in vaginal laxity. Pelvic floor muscle training should be the first-line treatment given its superior 6-month outcomes, with ThermiVa reserved as a second-line option for patients who cannot or will not engage in PFMT. 3