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The effect of combination treatment with low-intensity shockwave therapy and daily tadalafil on severe erectile dysfunction: a double-blind, randomized, sham-controlled clinical trial.
Kalyvianakis, Dimitrios; Mykoniatis, Ioannis; Pyrgidis, Nikolaos; Kapoteli, Paraskeui; Zilotis, Filimon; Hatzichristou, Dimitrios.
Afiliación
  • Kalyvianakis D; Department of Urology, Aristotle University of Thessaloniki, Thessaloniki 54635, Greece.
  • Mykoniatis I; Institute for the Study of Urological Diseases, Thessaloniki 54622, Greece.
  • Pyrgidis N; Department of Urology, Aristotle University of Thessaloniki, Thessaloniki 54635, Greece.
  • Kapoteli P; Institute for the Study of Urological Diseases, Thessaloniki 54622, Greece.
  • Zilotis F; Department of Urology, University Hospital, LMU Munich, Munich 81377, Germany.
  • Hatzichristou D; Department of Urology, Aristotle University of Thessaloniki, Thessaloniki 54635, Greece.
J Sex Med ; 21(6): 533-538, 2024 May 28.
Article en En | MEDLINE | ID: mdl-38600694
ABSTRACT

BACKGROUND:

Patients with severe erectile dysfunction (ED) remain the most challenging group in terms of available noninvasive treatment modalities.

AIM:

The study sought to assess the role of combination therapy with low-intensity shockwave therapy (LiST) and daily tadalafil 5 mg in a highly select group of patients with severe vasculogenic ED through a double-blind, randomized trial.

METHODS:

Forty-eight sexually active men were randomly assigned to 12 sessions of LiST 3 times weekly and tadalafil 5 mg once daily (n = 34) or sham therapy and tadalafil (n = 17) for 4 weeks. Patients were assessed at 1 and 3 months after completion of treatment.

OUTCOMES:

Improvement of erectile function was evaluated through the International Index of Erectile Function-Erectile Function domain (IIEF-EF) or 6-item IIEF and the Sexual Encounter Profile (SEP) diary. The primary outcome was the difference between the groups in the IIEF-EF at 3 months after completion of treatment. Secondary outcomes comprised (1) the difference between the groups in the IIEF-EF at 1 month after completion of treatment, (2) the difference between the groups in the "yes" responses to question 3 of the SEP diary at 1 and 3 months, and (3) the treatment-related adverse events. The number of patients attaining a minimal clinically important difference in the IIEF-EF (improvement of at least 7 points) was also assessed.

RESULTS:

After treatment, the absolute scores in the IIEF-EF were higher in patients receiving LiST and tadalafil vs sham therapy and tadalafil both at the 1-month (12.1 ± 2.4 vs 10.2 ± 1.7; P = .002) and at the 3-month (12.9 ± 2.1 vs 10.8 ± 1.8; P < .001) evaluation. Between the 2 groups, the proportion of "yes" responses to question 3 of the SEP diary was not statistically significant, whereas the number of patients attaining a minimal clinically important difference in the IIEF-EF was statistically significant only at the 3-month evaluation. No adverse events occurred. CLINICAL IMPLICATIONS Application of LiST in patients with severe vasculogenic ED receiving daily dose tadalafil may further improve erectile function compared with tadalafil as a stand-alone treatment on the short term. STRENGTHS AND

LIMITATIONS:

Although we provided the first study in the field, severe vasculogenic ED was defined based on medical history and clinical examination and not based on penile ultrasound measures.

CONCLUSION:

The combination of 12 sessions LiST 3 times weekly and daily tadalafil for 4 weeks led to a 2-point difference in the IIEF-EF compared with sham therapy and daily tadalafil among patients with severe vasculogenic ED after 1 and 3 months from completion of treatment.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Inhibidores de Fosfodiesterasa 5 / Tadalafilo / Disfunción Eréctil Idioma: En Revista: J Sex Med Asunto de la revista: GINECOLOGIA / MEDICINA REPRODUTIVA / UROLOGIA Año: 2024 Tipo del documento: Article

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Inhibidores de Fosfodiesterasa 5 / Tadalafilo / Disfunción Eréctil Idioma: En Revista: J Sex Med Asunto de la revista: GINECOLOGIA / MEDICINA REPRODUTIVA / UROLOGIA Año: 2024 Tipo del documento: Article