Pelvic floor disorders (PFDs) or pelvic dysfunctions include pelvic organs prolapse, urinary and fecal incontinence, feeling of vaginal swelling, as well as sexual symptoms, such as extreme vaginal laxity (1, 2). Previous studies have shown that many factors, including stroke, menopause, intra-abdominal increased pressure, ascites, a history of pelvic surgery, limited physical activity, hormone therapy, parity, vaginal delivery, age, race, body mass index, and congenital factors might be associated with PFDs (3, 4, 5).
The prevalence of at least one pelvic floor disorder is 23% that increases with age (3, 6). In Iran, Eftekhar et al. found 42% of women to have pelvic floor dysfunction (e.g., fecal and urinary incontinence, as well as pelvic organs prolapse) (1). The PFDs impose excessive costs on healthcare systems (7). In addition, PFDs can generate abundant problems in social relations, quality of life, and sexual dysfunction. Studies have demonstrated that sexual function and strength of pelvic floor muscles have a positive correlation. As we know, the pelvic floor muscles have a significant role in producing involuntary contractions, facilitating blood flow to the genitalia, and better sensitivity during sexual activity (8, 9).
Various invasive and non-invasive therapies have been applied for pelvic floor restoration. Invasive treatments entail different types of surgeries and non-invasive therapies are pelvic floor muscle exercise (Kegel exercise) (10), biofeedback (11), laser (12), and radiofrequency (RF) (13).
The RF is an energy-based device used to improve genital appearance, sexual function, stress urinary incontinence, lubrication, vaginal laxity, Genito-pelvic sensation, bowel incontinence, pelvic organ prolapse (POP), and chronic pelvic pain (13-16).
RF induces an inflammatory process through generating the heat of 40°C-45°C and stimulates fibroblasts leading to the proliferation of the glycogen-enriched epithelium, neovascularization, and collagen formation (13). Therefore, it is believed that RF is a safe and effective intervention for the management of PFDs as measured by several outcome measures, including the Pelvic Floor Distress Inventory (PFDI-20) and Female Sexual Function Index (FSFI-6). With this background in mind, the present study aimed to identify the clinical efficacy of RF on sexual function, pelvic floor restoration, and distress among women with PFDs. Furthermore, the patient satisfaction index after treatment was assessed based on the improvement of sexual, colorectal-anal, and urinary symptoms.

 

Study Design and Participants
This pre-post study was conducted on a study population of women, who referred to a pelvic floor clinic affiliated to Tehran University of Medical Sciences, Tehran, Iran during December 2019-July 2020.

Sample Size and Sampling
First, a sample size of 40 women was considered based on a previous study (13). A power of 80% at a 5% significance level was estimated for the present study. Consequently, in practice, 43 women were enrolled in the study. All women with PFDs were assessed and those meeting the inclusion criteria were entered into the study. The inclusion criteria entailed signing informed consent, being married, at least having one PFD, such as urinary incontinence, lower gastrointestinal tract problems (e.g., constipation, fecal or gas incontinence, splitting, and digitation) vaginal laxity, and sexual problems. The exclusion criteria were having uncontrolled conditions, such as diabetes mellitus and severe psychological disorders, having prosthesis or intrauterine devices, being a smoker, active infection, and severe prolapse needing surgery. All participants were asked to respond to the study questionnaires both at baseline and at three-month follow-up.

Measures
1. Demographic and medical information: A short questionnaire was used to collect data concerning the age, education, employment status, and medical history of patients, including the number of pregnancies, mode of delivery (vaginal or caesarian section), history of pelvic floor surgery, history of rectal tears and episiotomy. In addition, weight, height, chief complaint, urinary symptoms, colorectal symptoms, and sexual symptoms were recorded.
2. Clinical examination: The participants were examined three times by a urogynecologist for the tonicity of the levator muscle by vaginal exam pre-treatment, as well as one and three months post-treatment. They were classified into three grades the low, medium, and normal.
3. Biofeedback evaluation: We used electromyographic biofeedback for measuring the three indices of muscle contractions. An expert pelvic floor physiotherapist assessed the power average (µV), rest average (µV), and endurance (sec) of contractions. Biofeedback evaluation was performed at the first session and the three-month follow-up.
4. PFDI-20: The PFDI-20 contains three subscales with six, eight, and six questions regarding the inconvenience of the prolapse (POP Distress Inventory-POPDI), complications of defecation (Colorectal-Anal Distress Inventory-CRADI), and difficulties in urination (Urinary Distress Inventory-UDI), respectively. Primarily, all questions have yes and no answers. The answers are scored based on a Likert scale of 0-4 with 0 for “No” and 1-4 for “Yes”. The score could be derived from the mean of the answered items in any subscales multiplied by 25 (rang: 0-100). The lower scores indicate lower distress. The total score is obtained as the sum of sub-scores (range: 0-300) (6). The Iranian version of the PFDI-20 showed acceptable validity and reliability (17).
5. FSFI-6: The FSFI-6 is a measure for assessing sexual function among females based on the following subscales: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. Sexual desire and satisfaction are scored based on a Likert scale with a range of 1-5. Moreover, arousal, lubrication, orgasm, and pain have a range of 0-5. The total score could be obtained by computing six sub-scores. The total score ranges from 2 to 30 with higher scores indicating better sexual performance. Scores less than 19 demonstrate the need for further interventions (18). The psychometric properties of the Iranian version of FSFI-6 are reported elsewhere (19).

Intervention
The Higgs device made by the Maya Slim Company was used for intervention. One disposable applicator (IQA: Intra Quadratic Applicator) was allocated to each patient. We used two programs for standard therapy, the first of which was the endothermy program that generates homogeneous heat inside the body between applicator and grounding pad leading to increased blood circulation in that area. This program endures 15 min with a device power of 10 W without pulling out IQA from the patient’s body. The second program was Endogym Areo, which stimulates aerobic exercises that endure 30-40 min at 35 W. Patients underwent Higgs treatment three times fortnightly based on the protocol provided by the same company.

Statistical Analysis
Descriptive statistics, including mean, standard deviation, frequency, and percentage were used to describe the data. The paired samples t-test was used to compare pre- and post-intervention in terms of pelvic floor distress, sexual function, and biofeedback results. In addition, the Friedman test was used for pre-post comparisons because a physical exam was performed by a gynecologist and the data were ordinal. The SPSS software version 23 (SPSS Inc., Chicago, IL., USA) was used for data analysis. The significance level was considered P-value< 0.05.

Ethics
The Review Board of the Tehran University of Medical Sciences approved the study (IR.TUMS. IKHC.REC.1398.294).