Extract

Objective

To evaluate the efficacy, safety and predictive factors of collagenase clostridium histolyticum (CCH) in the treatment of Peyronie's disease (PD) using the modified treatment protocol.

Methods

A prospective study of 89 men with PD that completed at least 1 course (3 injections) of CCH treatment at a single centre. The majority (77.5%) received 1 course of treatment, with 16.9%(n=15) and 5.6%(n=5) completing 2 or 3 courses respectively. The angle of curvature assessment after PGE1 injection, the International Index of Erectile Function (IIEF), Peyronie's Disease Questionnaire (PDQ) and Global Assessment (GAPD) were completed at baseline and 4 weeks after the last injection of each course. Co-morbidities and risk factors for PD were recorded at baseline. The range of curvature improvement (RI) was assessed as improvement<14°; 15°-20°; and >21°.

Results

The baseline curvature was 54±17.3°. There was a mean improvement following 1 treatment course of 31%(17±10.4°). Of those men that opted for a second treatment course there was a 36% improvement from baseline (23.3±10°). After a third course of CCH treatment there was a 52.3% improvement from baseline (35 ± 9.4°). There was significant improvement in IIEF and PDQ domains. CCH was well tolerated with only one patient experiencing significant side effects (penile fracture). Overall 11%(n=10) patients experienced local and transient mild side effects. There was no association between the number of treatment courses and severe side effects. Following treatment with CCH, 9%(8/89) of the men opted for surgical correction. Men with a greater curvature(>70;n=22) responded significantly better to CCH than men with minor curvature (<45;n=36). Patients with curvature<45° seemed to have improvement<14°(p<0.0001) and patients with curvatures>70° to have improvement>20°(p=0.02). Men that had PD for more than 12 months (n=46) responded significantly better to CCH and were more satisfied regarding the treatment than men with PD for less than 12 months (n=41). Twenty out of 46(43.5%) patient affected by PD for more than 12 months had a improvement>21°vs7/41(17%) men with PD for less than 12 months(p=0.007). Micro-calcification on US(p=0.8) and point of injection(p=0.9) appeared not to be correlated to the outcome.

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