(003) New Treatment Approach for Female Sexual Dysfunction by Transvaginal Shockwave Therapy (TVST)

Abstract

Abstract Introduction Female Sexual Dysfunction (FSD) is a common condition of women especially following menopause. In recent years, energy-based devices (EBD), such as lasers and radio-frequencies, have been marketed for vaginal rejuvenation and FSD. Low-intensity shockwave therapy (LIST) has been introduced as a treatment for male erectile dysfunction and may hold promise for FSD. In women energy has to be delivered to the vaginal wall to manifest its tissue regenerative potential. In this pilot study, we evaluated a specially designed transvaginal probe, which is able to deliver shockwave energy to the vaginal wall and the external genitalia. Objective To evaluate the safety and therapeutic efficacy of LIST, when applied transvaginally for the treatment of FSD and incontinence. We call this approach transvaginal shockwave therapy (TVST). Methods The study was a single-arm, pilot study conducted between February-August 2021. Fifteen female patients aged 45-61 years (mean age: 52.7 years) were recruited and 78.6% of them were post-menopausal. All women presented with sexual dysfunction and 7 of them (46.7%) also reported urinary incontinence. Treatment was performed with the MoreNova system (Hikkonu Ltd., Israel), an electromagnetic low-intensity shockwave generator, using a novel transvaginal probe. Energy flow density was 0.09 mJoule/mm2 and intensity was gradually increased to the maximal tolerable level (1.6-1.8). Each session delivered 400 shockwaves to 6 predefined anatomical areas: the frontal vaginal wall (11 and 1 o' clock positions), the labia minora and majora (left, right). Patients underwent a total of 6 treatment sessions over the course of three weeks (2 per week). Statistical analysis was performed using student’s t-test (paired, one-tail, significance at p<0.05). Results Sexual dysfunction was assessed with the Female Sexual Function Index (FSFI) and incontinence with the ICIQ-UI Short-Form. Evaluations were performed at baseline and at 1 and 3 month post treatment. One patient aborted (for reasons unrelated to treatment) and was excluded from analysis. No patient complained of pain or discomfort during or after treatment and no side-effects were reported. Mean total FSFI score at baseline was 13.93, increased significantly to 22.66 at 1 month and slightly decreased to 20.88 at 3 months post treatment. All domains of the FSFI were significantly improved both at 1 and 3 month follow-ups compared to baseline. Percentage of patients achieving minimally clinically important differences (MCID) of the FSFI domains (Krychman et al, 2018) was also estimated. It was found that at 1 month follow-up more than 70% of patients achieved improvements exceeding the MCID in the pain, orgasm and lubrication FSFI domains. At 3 months, this significant improvement was sustained in the pain and orgasm domains. Mean ICIQ-UI was 3,53 at baseline and decreased to 3 at 3 months and 2.28 at 3 months post treatment. Conclusions There is a great need for new, effective and safe therapies for FSD. Quite often FSD is not reported by the patients and disregarded by physicians who are not involved in sexual medicine. Robust scientific evidence as to the efficacy of EBDs is also lacking. In our study, we found that TVST is safe and very well-tolerated by the patients. It improved FSD up to 3 months post treatment and this improvement was evident in all domains of the FSFI. There was also improvement in incontinence, as documented by the ICIQ-UI index. This observation surely warrants further investigation. Our data, although limited, underline the need for large scale, controlled studies ideally targeting different genito-urinary conditions. Disclosure Yes, this is sponsored by industry/sponsor: Direx Clarification Industry funding only - investigator initiated and executed study.