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resume all activity as normal, including sexual intercourse, immediately after each treatment. The nature of the data (discrete, not continuous),
necessitated the use of non-parametric statistical methods overall because data are not normally distributed with the traditional cut-off of p<0.05 for measure of statistical significance via Wilcoxon test; the Bonferroni correction was employed where appropriate, making the cut-off value for some data groups p<0.0125. Statistically significant improvement in VLQ and SSQ
scores from baseline were noted in all cases. Notably, while the patient VLQ assessment data was used for analysis, differences between patient and physician evaluation of vulvovaginal laxity were rare and overall found to be statistically insignificant (p=0.0001). Table 2 shows the median scores and level of improvement from baseline for the sake of comparison. As seen in Table 2, the most pronounced improvement
Evaluation of vulvovaginal laxity was made on a 7
point scale by both the investigating physician and patient self-assessment via VLQ11
; the patient assessment
data was used for analysis. A 6 point sexual satisfaction scale11
Table 1 delineates these scales. Assessment occurred at baseline, 10 days after first
treatment, before second treatment, before third treatment, and 30 days after the third treatment session. In addition, patients were asked to give a global assessment asking if they would recommend the procedure to a friend or family member (a 5 point scale where 1=strongly agree and 5=strongly disagree) and to rate overall satisfaction with the procedure (a 5 point scale where 1=very unsatisfied and 5=very satisfied).
Results Of the original 23 subjects, 6 were lost to follow-up before each of the second and third treatments, reportedly due to high satisfaction with results not necessitating further treatment in the opinion of the patient. There were no burns, blisters or major complications during or after treatments, which were described as pleasant and very comfortable. All patients (n=23) received at least one treatment, with 17 undergoing a second treatment and 11 opting for a third. Average treatment time was approximately 10 minutes for the labia and 15 minutes for the vagina, totaling 25 minutes. Patients were able to
was also used by patients to rate sexual satisfaction.
Figure 3 (A) Before (baseline) and (B), (C), and (D) after (treatments 1, 2, and 3) images of nulliparous woman, age 52 years, presenting with laxity of the vagina and labia majora, atrophic vaginitis, incontinence, and orgasmic dysfunction. Outcome after three treatments with TTCRF included statistically significant improvement in laxity with visible aesthetic improvement, significant reduction of orgasmic dysfunction, and complete resolution of incontinence and atrophic vaginitis
in VLQ is seen 10 days after the first treatment, with little difference noted before treatment two, suggesting that much of the result manifests rapidly. There is immediate visible correction after treatment with additional effect over time. There is some additional improvement with a second treatment, and minimal improvement with a third treatment. A similar trend can be seen for the SSQ results. It should be noted that improvement in VLQ score between sessions two and three was also statistically significant, if modest. The overall results also correlate with patient behavior.
Six patients did not return for a second treatment, and 6 opted out after two treatments, happy with results and seeing no need for further treatment. All patients finishing a full course of treatment reported
that they were very satisfied and strongly agreed that they’d recommend the procedure (scores of 5 on both global assessments).
Figure 4 (A) Before and (B) after images of nulliparous woman, age 52 years, presenting with laxity of the vagina and labia majora, atrophic vaginitis, and orgasmic dysfunction; outcome after three treatments with TTCRF included statistically significant improvement in laxity with resolution of atrophic vaginitis and orgasmic dysfunction
20
Discussion The tightening result is visible immediately after the first treatment and the full outcome takes a few months to fully manifest regardless of the number of sessions, but after even a single treatment the median change in the VLQ score was 3 points on a 7 point scale at the second treatment visit. Median change in SSQ score during that time was more modest but still notable (1.5). As demonstrated in those patients (n=17) electing to undergo at least one more treatment, median change in VLQ score showed that the strongest improvement occurred after the first treatment but additional, statistically significant improvement was available with a second and third session. Improvement measured by self-reported SSQ improved similarly but much less dramatically after the first session. It may be that after the first treatment pronounced improvement is perceived, with any additional improvement in sexual satisfaction appearing minimal with additional treatment, likely due to the challenge associated with self-assessment of sexual satisfaction. Small, incremental rises are less noticeable but were still reported by some patients. Overall this suggests that while one or two sessions may be
August/September 2015 |
prime-journal.com
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