Vaginal laxity or looseness is a relatively prevalent disorder that influences woman’s sexual satisfaction and quality of life. It has been reported that 24 to 38% of women suffer from vaginal laxity. It has been associated with parity, symptoms of prolapse, stress urinary incontinence, overactive bladder, reduced vaginal sensation during intercourse, and worse general sex life (1, 2).
Pelvic Organ Prolapse (POP) is known as the intra-pelvic organs descending due to weakness in the supporting structures. It is a common condition among up to 20% of women under the age of 45 and has been reported as high as 39.8% among elderly woman (3). Pelvic organ prolapse may decline quality of life as well as sexual satisfaction (4).
The radiofrequency technology has been used to improve vaginal laxity, and pelvic organ prolapse, sexual function, lubrication, genito-pelvic sensation, and considered widely safe and effective (5, 6). Vicariotto et al. showed that radiofrequency was a safe treatment with a rapid and persistent consequence on vaginal laxity and sexual satisfaction for 12 months follow up. Also, Millheiser et al. found that radiofrequency was effective on subjective improvement in self-reported vaginal tightness, sexual function and decreased sexual distress (7).
In another study among women suffering from vaginal laxity after vaginal childbirth, a 30-minute office procedure using radiofrequency, improved the sexual satisfaction as well as decreasing the sexual distress for 12 months (8).
Radiofrequency has varied types, such as monopolar radiofrequency and Dynamic quadripolar radiofrequency. We used Higgs radiofrequency made by Danesh Bonyan Maya Slim Aria Company.
This study aimed to evaluate the impact of Higgs radiofrequency on pelvic organ prolapse and sexual function among women suffering from vaginal laxity.

 

Study Design and Participants

This was a pre- and post-intervention study design on a sample of women who referred to a pelvic floor clinic affiliated with Tehran University of Medical Sciences in Tehran, Iran, during December 2017 to July 2018. All women, who had sexual dissatisfaction suffering from vaginal laxity were assessed. The inclusion criteria were having signed informed consent, being married, aged 18 up to 50, having normal pop smear in recent three years. The exclusion criteria were suffering from immune suppressive diseases, having the Intra Uterine Devices, having cardiac pace maker, being pregnant or in lactation, a history of diabetes or increased blood pressure and skin diseases. All participants were asked to respond the study questionnaire twice: at baseline (before intervention) and three months follow-up evaluation. Also, an urogynecologist examined participants in terms of pelvic organ prolapse before and three months after intervention. All participants evaluated in dorsal lithotomy position after emptying their bladders.
 

Measurements

1. Demographic and medical history: A self-designed questionnaire was used to collect data on patients’ demographic information such as age, medical history including number of gravidities and vaginal or cesarean section delivery, weight, height and score of vaginal laxity.
2. Pelvic Organ Prolapse Quantification (POP-Q): This contains six points (Aa, Ba, C, D, Ap, Bp). The POP-Q was used to report the level of descent or prolapse of the anterior vaginal wall (Aa, Ba), vaginal apex (C, D), and posterior wall (Ap, Bp). The locations of these points are evaluated through maximal Valsalva or cough in relation to the hymen. If the point descends to the hymen, it is measured as 0 cm, if it remains above the hymen, it is described as negative numbers and if it descends outside the hymen, it is measured as positive numbers. Also, there are other measurements, which are documented independent of the hymen (point of genital hiatus GH, point of perineal body PB, and point of total vaginal length at rest TVL) (9).
3. Female Sexual Function Index (FSFI-19): The 19-item FSFI assesses the dimensions of females’ sexual function among both clinical and community populations. FSFI includes six subscales consisting desire, arousal, lubrication, orgasm, satisfaction and pain. All subscale scores ranged Likert type from 0 to 5. Higher scores indicate better sexual functioning. Total score were obtained summing the subscale scores (10). Scores of 28 or lower were identified as the cutoff for sexual dysfunction. The Iranian version of the FSFI is a valid and reliable tool (11).
 

Intervention Protocol

We used Higgs device made by Danesh Bonyan Maya Slim Company. The protocol was performed of two packages including 6 sessions. Package 1: included 3 sessions weekly. After 15 days, package 2 was started weekly. One disposable applicator (IQA: Intra Quadratic Applicator) assigned to each patient for each treatment. For standard therapy, we used two programs: endothermy and endogym. Endothermy program generates homogeneous heat inside body between applicator and grounding pad thus increasing blood circulation in that area. This program endures 15 minutes. The second program started which is endogym. This program stimulates aerobic exercises that endures 30 minutes.
In both packages, at first session, grounding pad was attached on patient’s body in front of pubic area; at second session, it was attached under the buttock; and at third session was attached on patient’s body in front of pubic area.
1. Protocol of therapy sessions for mild laxity:
Session1: endothermy, warm endogym
Session 2: endothermy, aerobic endogym
Session 3: endothermy, warm endogym
2. Protocol of therapy sessions for severe laxity:
Session 1: endothermy, aerobic endogym.
Session 2: endothermy, cold endogym
Session 3: endothermy, aerobic endogym
 

Statistical Analysis

We used the SPSS version 23 (SPSS Inc., Chicago, Ill., USA) for data analyzing. Descriptive statistics and the paired samples t-test were used for exploring the data and comparing before and after radiofrequency implication. The significant level was set at P-value< 0.05.