Efficacy of Intracavernosal (Xeomin®) 100U as add-on Therapy to Sildenafil 100 mg on Demand Compared to Sildenafil 100 mg on Demand for the Treatment of Erectile Dysfunction (ED) Not Sufficiently Responsive to Standard Therapy With Phosphodiesterase Type 5 Inhibitors
Abstract
The primary objective of this study is to investigate the efficacy of intracavernosal (Xeomin®) (100U) as add-on therapy to sildenafil 100 mg on demand in men with ED and insufficient response to standard therapy with 100 mg sildenafil on demand during the 4-week open-label run-in phase.
The secondary objectives are to further describe the efficacy and safety of (Xeomin®) 100U IC as add-on therapy to sildenafil 100 mg on demand:
1. to further assess efficacy using.
* i) a log diary five-item questionnaire completed after each sexual attempt (Sexual Encounter Profile);
* ii) a self-reporting measure that scores erection hardness on a 4 point scale completed after each sexual attempt;
* iii) The Global Assessment Question.
2. to assess effect persistence at month 6 and month 9.
3. to assess safety of (Xeomin®) 100U IC in combination with sildenafil 100 mg on demand.
Conditions: Erectile Dysfunction.
Primary outcome: Change in the erectile function; Change in SEP2; Change in SEP3.
Enrollment: 226 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 226 participants or records.
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