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Al Kassir K1,2,3, Wakim J4, Yammine N5,6,7,8
1Lebanese University, Physical Therapy, Beirut, Lebanon, 2Lebanese German University, Physical Therapy, Jounieh, Lebanon, 3Beit Chabab Hospital, Physical Therapy, Beit Chabab, Lebanon, 4Antonine University, Physical Therapy, Baabda, Lebanon, 5Lebanese University, Medicine Urology, Hadath, Lebanon, 6Hopital Rene Dubos Pontoise, Urology, Pontoise, France, 7Beit Chabab Hospital, Urology, Beit Chabab, Lebanon, 8Jeitawi Hospital, Urology, Beirut, Lebanon
Background: Erectile dysfunction (ED) is defined as the persistent inability to achieve or maintain an adequate erection for satisfactory sexual activity. The most common etiology for ED is vasculogenic disorder. Patients with ED are effectively treated with 20 milligrams of Phosphodiesterase type 5 inhibitors (PDE-5i), and moderately with a daily dosage of 5mg of PDE5i. These treatments are associated with side effects, nevertheless a proportion of men do not respond to these therapies. For this group alternative options could be urethral suppositories for erection, incorporeal injection and penile prostheses. These options are effective, hence long-term usage rates have complications.
Radial Low-intensity extra-corporeal shock wave therapy (LI-ESWT) is a modality that is recently developed for the treatment of ED. Results from experiments have provided evidence that LI-ESWT induces cellular micro-trauma, which in return stimulates the release of angiogenic factors and the subsequent neovascularization of the treated tissue, to enhance their sexual function and self-confidence with no side effects.
Purpose: Will the Radial LI-ESWT improve more and maintain the erection to completion of sexual intercourse with confidence in patients suffering from ED and taking 5mg/day of PDE-5 inhibitors versus patients treated with only the same dosage of PDE-5 inhibitors?
Methods: A single-blinded randomized controlled trial was conducted over 2 years, on 62 ED patients aged between 40 and 60 years referred by the urologist and undergoing the PDE-5i treatment since minimum of 1 month. Eight sessions, once per week, were conducted by 2 physical therapists, one performing the test and the other to execute the radial LI-ESWT . An experimental group (G1) composed of 32 ED patients who received on the penile tissue, 9000 shocks of radial LI-ESWT using BTL6000-Topline machine, at a pressure of 2 bars, with 5 mg per day of PDE-5i, and a comparative group (G2) is composed of 30 ED patients receiving only 5 mg/day of PDE-5i.
Before (t0) and after results (t1), in addition to a follow-up after 3 months (t2) from the last session were tested for the 5 criteria issued from the "International Index of Erectile Function" (IIEF-5).
Results: After using the statistical test “Shapiro-Wilk” both groups were normally distributed at t0 (G1 Pvalue=0.65; G2 Pvalue=0.76). Independent T-test at t0 gave a non-significant difference between both groups (Pvalue=0.50). Dependent T-test was used to evaluate each group at t1 and t2 in comparison with t0 and gave significant results for each, which means both treatments were efficient treating ED. Independent T-test was used to compare G1 to G2 at t1 and t2 and gave a significant result (Pvalue=0.00) meaning that Li-ESWT combined to 5mg of PDE-5 was clearly more efficient.
Conclusion(s): We note that Radial LI-ESWT combined to 5mg/day of PDE-5i have an important short and long term action on stimulating angiogenic factors and promoting neovascularization of the treated tissue which resulted in a signaficant higher increase in the score of the IIEF-5 than PDE-5i treatment alone.
Implications: There is an advantage in introducing Radial LI-ESWT in the rehabilitation for patients suffering from ED and responding to 5mg of PDE-5 inhibitors.
Keywords: Radial Extra-corporeal Shock-wave Therapy, Erectile Dysfunction, Phosphodiesterase type 5 inhibitors
Funding acknowledgements: This Research was supported by the Medical Committee at Beit Chabab Hospital and the Research Department of BTL Company.
Radial Low-intensity extra-corporeal shock wave therapy (LI-ESWT) is a modality that is recently developed for the treatment of ED. Results from experiments have provided evidence that LI-ESWT induces cellular micro-trauma, which in return stimulates the release of angiogenic factors and the subsequent neovascularization of the treated tissue, to enhance their sexual function and self-confidence with no side effects.
Purpose: Will the Radial LI-ESWT improve more and maintain the erection to completion of sexual intercourse with confidence in patients suffering from ED and taking 5mg/day of PDE-5 inhibitors versus patients treated with only the same dosage of PDE-5 inhibitors?
Methods: A single-blinded randomized controlled trial was conducted over 2 years, on 62 ED patients aged between 40 and 60 years referred by the urologist and undergoing the PDE-5i treatment since minimum of 1 month. Eight sessions, once per week, were conducted by 2 physical therapists, one performing the test and the other to execute the radial LI-ESWT . An experimental group (G1) composed of 32 ED patients who received on the penile tissue, 9000 shocks of radial LI-ESWT using BTL6000-Topline machine, at a pressure of 2 bars, with 5 mg per day of PDE-5i, and a comparative group (G2) is composed of 30 ED patients receiving only 5 mg/day of PDE-5i.
Before (t0) and after results (t1), in addition to a follow-up after 3 months (t2) from the last session were tested for the 5 criteria issued from the "International Index of Erectile Function" (IIEF-5).
Results: After using the statistical test “Shapiro-Wilk” both groups were normally distributed at t0 (G1 Pvalue=0.65; G2 Pvalue=0.76). Independent T-test at t0 gave a non-significant difference between both groups (Pvalue=0.50). Dependent T-test was used to evaluate each group at t1 and t2 in comparison with t0 and gave significant results for each, which means both treatments were efficient treating ED. Independent T-test was used to compare G1 to G2 at t1 and t2 and gave a significant result (Pvalue=0.00) meaning that Li-ESWT combined to 5mg of PDE-5 was clearly more efficient.
Conclusion(s): We note that Radial LI-ESWT combined to 5mg/day of PDE-5i have an important short and long term action on stimulating angiogenic factors and promoting neovascularization of the treated tissue which resulted in a signaficant higher increase in the score of the IIEF-5 than PDE-5i treatment alone.
Implications: There is an advantage in introducing Radial LI-ESWT in the rehabilitation for patients suffering from ED and responding to 5mg of PDE-5 inhibitors.
Keywords: Radial Extra-corporeal Shock-wave Therapy, Erectile Dysfunction, Phosphodiesterase type 5 inhibitors
Funding acknowledgements: This Research was supported by the Medical Committee at Beit Chabab Hospital and the Research Department of BTL Company.
Topic: Women's & men's pelvic health; Electrophysical & isothermal agents; Health promotion & wellbeing/healthy ageing
Ethics approval required: Yes
Institution: Beit Chabab Hospital
Ethics committee: Medical Commitee of Beit Chabab Hospital
Ethics number: approved by the committee, without clinical-trial number from NIH
All authors, affiliations and abstracts have been published as submitted.
