Effectiveness and safety of combined autologous Platelet Rich Plasma and Focal Shockwave Therapy for the treatment of erectile dysfunction

Conditions

Erectile dysfunction

Brief summary

Change in IIEF-EF score between baseline and week 21

Detailed description

Change in IIEF-EF score between baseline and week 13, Change in IIEF-EF score between baseline and week 33, Proportion of patients achieving the minimum clinically meaningful difference in IIEF-EF score (5 points), at weeks 13, 21, and 33, Change in EHS score between baseline and measurements at weeks 13, 21, and 33, Proportion of patients achieving vaginal penetration after treatment, as assessed by change in EHS from 1 or 2 at baseline to 3 or 4 at weeks 13, 21, and 33, Change in Sexual Quality of Life Questionnaire - SLQQ score between baseline and measurements at weeks 13, 21, and 33, Change in Global Assessment Questionnaire Score - GA at Weeks 13, 21, and 33, Incidence of PRP-related adverse events during the study.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPLATELET CONCENTRATE

Eligibility

Sex/Gender

Male

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change in IIEF-EF score between baseline and week 21	—

Secondary

Measure	Time frame
Change in IIEF-EF score between baseline and week 13, Change in IIEF-EF score between baseline and week 33, Proportion of patients achieving the minimum clinically meaningful difference in IIEF-EF score (5 points), at weeks 13, 21, and 33, Change in EHS score between baseline and measurements at weeks 13, 21, and 33, Proportion of patients achieving vaginal penetration after treatment, as assessed by change in EHS from 1 or 2 at baseline to 3 or 4 at weeks 13, 21, and 33, Change in Sexual Quality of Life Questionnaire - SLQQ score between baseline and measurements at weeks 13, 21, and 33, Change in Global Assessment Questionnaire Score - GA at Weeks 13, 21, and 33, Incidence of PRP-related adverse events during the study.	—

Measure

Time frame

Change in IIEF-EF score between baseline and week 13, Change in IIEF-EF score between baseline and week 33, Proportion of patients achieving the minimum clinically meaningful difference in IIEF-EF score (5 points), at weeks 13, 21, and 33, Change in EHS score between baseline and measurements at weeks 13, 21, and 33, Proportion of patients achieving vaginal penetration after treatment, as assessed by change in EHS from 1 or 2 at baseline to 3 or 4 at weeks 13, 21, and 33, Change in Sexual Quality of Life Questionnaire - SLQQ score between baseline and measurements at weeks 13, 21, and 33, Change in Global Assessment Questionnaire Score - GA at Weeks 13, 21, and 33, Incidence of PRP-related adverse events during the study.

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Countries

Spain

Outcome results

None listed