HIFEM procedure for Treatment of Urinary Incontinence Accompanied with Female Sexual Dysfunction: 1-year Follow-up Data

Abstract

ABSTRACT Introduction The pelvic floor muscles (PFMs) have an essential role in the structural support for the pelvic organs. Weakening of the PFMs, primarily due to childbirth, may lead to urinary incontinence (UI), impairment of sexual function, and possible development of female sexual dysfunction (FSD). Objective This multi-center study aims to investigate the long-term effectiveness of HIFEM-induced PFMs strengthening to reduce UI and improve female sexual function. Methods Thirty-one females (47.9±8.6 years) diagnosed with UI and FSD symptoms (FSFI baseline score <26.55) underwent a total of six HIFEM procedures. Treatments were scheduled twice a week over three weeks with five follow-up visits at 1, 3, 6, 9, and 12 months after the final treatment. The stimulation intensity was gradually set according to the patient's feedback. Standardized questionnaires evaluating UI and sexual function (ICIQ-UI SF, FSFI, and PISQ-12) and Therapy Comfort Questionnaire were administered. Due to patients’ drop-out at the last two follow-up visits (9 and 12 months), data evaluation was divided into two subgroups – patients monitored from baseline to 6 months (Group A, N=31) and from baseline to 1 year (Group B, N=17). Results At baseline, the ICIQ-UI SF score showed 12.1±4.8 points (A) and 12.5±4.7 points (B) on average, referring to moderate to severe UI symptoms. The severity of UI significantly (P<0.001) decreased post-treatment, and subjects achieved the most noticeable improvement of 69.7% (A, -8.5 points) and 71.7% (B, -8.9 points) at 6-month follow-up. In both groups, patients reported lesser leakage occurrence during certain activities, especially when coughing, sneezing, or physically active. At six months, 25% of patients had no UI symptoms, as shown by the zero score from ICIQ-UI SF (A). The results of Group B indicated the maintenance of achieved outcomes up to 12 months.Two patients with no sexual activity were excluded from FSFI and PISQ-12 evaluation in both groups. FSFI baseline score indicated considerable impairment of sexual function with an average score of 18.4±5.8 points (A) and 20.4±3.5 points (B). The improvement from 7.4 to 9.4 points was noticeable immediately after the final treatment and maintained during the whole follow-up, with an insignificant decline at one month (B) and six months(A). At 12 months after the last treatment, 71.4% of patients were above the threshold for FSD as described by the FSFI. The most notable changes were seen in the following subdomains: Orgasm, Lubrication, Arousal, and Satisfaction response. Lastly, the PISQ-12 score was also continuously increasing from baseline values (28.1±5.8 and 28.9±4.3 points for Group A and B), peaking at three months (+10.2 points in Group A) while maintaining up to 12 months (+10.2 points in Group B). Patients reported higher orgasm frequency, lubrication, and increased sexual desire. Furthermore, 93.3% of subjects agreed that the therapy was comfortable, and no adverse events were documented. Conclusions Our results suggest that the HIFEM procedure considerably reduces the severity of UI. In addition, the treatment enhances female sexual function; and may result in more frequent orgasms and increased sexual desire. Outcomes showed to be maintained during the observed period. Disclosure Yes, this is sponsored by industry/sponsor: BTL Industries Clarification Industry initiated, executed and funded study