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

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