Hypothesis / aims of study
To the best of our knowledge, this is the first study performed worldwide that assesses treatment of female sexual dysfunction and stress urinary incontinence by minimally invasive (transvaginal) application of low intensity shockwave energy. This study's purpose was to evaluate the therapeutic benefit and safety of low intensity shockwaves, while utilizing a novel shockwave transducer ('LALIS') designed to transfer therapeutic shockwaves both topically, as well as transvaginal.
Low Intensity Shockwaves have been researched during the past 13 years for the potential treatment of myocardial ischemia, wound healing and erectile dysfunction following initial reseach and animal studies that first demonstrated their angiogenetic qualities .
Multiple studies in vitro and in vivo confirmed that low intensity shockwave treatment enhances fibroblast proliferation and differentiation by activation of gene expression for transforming growth factor β1 (TGF- β1) and collagen types I and III. In addition, an increase of nitric oxide (NO) release is even reported in early stage of the treatment and the subsequent activation of endothelial nitric oxide synthase (eNOS) and of vascular endothelial growth factor (VEGF) are related to TGF- β1 rise.
Recently, several studies have demonstrated the effect of low intensity shockwaves for treating vestibulodynia  and stress urinary incontinence . These studies were conducted by way of external-only/topical application of the shockwaves and none-the-less generated clinical results that warrant further investigation.
Our expectation was that the application of LALIS shockwaves – combining transvaginal and topical application – would:
• Stimulate the release of growth factors in vaginal tissue, resulting in the generation of new blood vessels
• Enhance sensitivity in the vagina to improve sensation
• Increase natural lubrication production
• Tighten tissue and strengthen muscles to improve continence
Study design, materials and methods
The study was a triple-arm pilot study whereas 21 female patients, between March and November 2020, with either stress urinary incontinence or symptoms of sexual dysfunction or both were recruited. All patients were experiencing symptoms for no less than 6 months prior to their participation and all gave informed consent to participate in this study. During each treatment session, patients received application to six different regions using a MoreNova shockwave system with external and transvaginal treatment probes. Application was done to the labia majora (bilateral), to the labia minora (bilateral) and two applications to the vaginal wall, orientated to tissue and muscles surrounding the urethra – once to the left and once to the right. Ultrasound gel was used as a lubricant and no pain relief medicines or ointments were required. 350 shockwaves were administered per treatment area, resulting in a total of 2100 shockwaves per session. Each patient received 6 treatment sessions over the course of 3 weeks whereas the energy level used corrlates to and energy density of 0.09mJoule/mm2 in the targeted tissue.
Inclusion Criteria included:
• Age 18 - 60 y.o.
• Decrease or loss of sexual desire and/or SUI symptoms > 6 months
• Active sexual activity
Exclusion Criteria included:
• Mental disorders or psychiatric diseases.
• Diagnosed Decrease or loss of sexual desire (HSDD) is situational (reactive) or lifelong
• Inflammatory diseases of pelvic organs, infections of the genitourinary system, cervicitis, interstitial cystitis, vulvodynia or severe atrophy of the vaginal epithelium, precluding normal sexual activity.
• Surgical interventions or cosmetic surgeries on reproductive organs or vulva area during past 6 months.
• Neurological disease with loss of sensitivity in genital area.
• Pregnant and nursing women or non-lactating women during the first 6 months after childbirth.
• Alcohol addiction or drug addiction.
For assessment, Female Sexual Function Index (FSFI) and ICIQ-UI short form patient questionnaires were completed before and during treatment, as well as 1 and 3 months post treatment. Adverse events, discomfort and/or complaints during or following treatment sessions were recorded.
Of the 21 women recruited, 8 were diagnosed with stress incontinence, 9 were dianosed with sexual dysfunction and 4 were diagnosed with both conditions.
The treatments were well tolerated by all the subjects in this study. No adverse effect associated with low intensity shockwaves were recorded, including pain, hematuria or skin ecchymosis. Furthermore, no complaints about irritation or discomfort during, and post treatment, were recorded.
Of the 12 patients with urinary incontinence symptoms, the average baseline ICIQ-UI short form score was 17.58 (standard deviation - STD: 2.50). The average score gradually improved during (average score of 14.33 after 3 treatment sessions) and immediately following the entire treatment of 6 sessions (average score of 11.00), reaching an average of 7.33 (STD: 2.90) at 1 month follow-up and 7.25 (STD: 2.90) at 3 months follow up.
Of the 13 patients with sexual dysfunction symptoms, the average baseline FSFI score was 10.81 (standard deviation - STD: 3.00). The average score gradually improved during (average score of 17.12 after 3 treatment sessions) and immediately following the entire treatment of 6 sessions (average score of 21.92), reaching an average of 28.68 (STD: 6.16) at 1 month follow-up and 28.99 (STD: 8.20) at 3 months follow up.
Interpretation of results
The results as recorded by the relevant questionnaires, although limited in patient quantity, point to clinically significant improvements - both for patients suffering from stress urinary incontinence and/or those with sexual dysfunction symptoms. The peaked significant improvement for both categories of patients was achieved at one month post treatment: an average improvement of 10.3 points in the ICIQ-UI scores and an average improvement of 18.2 points in the FSFI scores. As the 3 month follow up was important in order to rule out the dominance of a near term placebo effect, we experienced no significant improvement, nor decline, between the 1 month and 3 month follow up dates.
No complications, side effects nor discomfort or complaints were recorded for all 21 patients and this strengthens the safety profile of this new minimally invasive procedure.