Use of intralesional collagenase in the treatment of peyronie’s disease: A review

Table 1 Study designs

Ref.	No. of patients	Study design	Length of study	Control group	Length of follow up
Gelbard et al[22]	31	Prospective	Mean of 22 mo per patient	None	9.8 mo (mean)
Gelbard et al[23]	49	Double blind, RCT	3 mo	Placebo	3 mo
Jordan[24]	25	Prospective	9 mo	None	None
Gelbard et al[25]	147	Double blind, RCT	Up to 18 wk	Placebo	None
Gelbard et al[26]	832	Double blind, RCT	Up to 52 wk	Placebo	None

RCT: Randomised controlled clinical trial.

Table 2 Study treatments

Ref.	Intralesional injection therapy dose and schedule
Gelbard et al[22]	One daily dose of 470620 μg/mL (15 patients) or 910 μg/mL (16 patients) for three consecutive days
Gelbard et al[23]	CCH single injection (6000-14000 Units)
Jordan[24]	Three 10000 Units injections administered over 7-10 d, repeated at 3 mo
Gelbard et al[25]	CCH 0.58 mg (10000 Units), 2 injections 24-72 h apart, repeated every 6 wk for up to 3 cycles
Gelbard et al[26]	CCH 0.58 mg (10000 Units), 2 injections 24-72 h apart, repeated every 6 wk for up to 4 cycles

CCH: Collagenase clostridium histolyticum.

Table 3 Adverse events

Ref.	Adverse effects (n)
Gelbard et al[22]	Ecchymosis (21), Pain (2), Albuginea rupture (1)
Gelbard et al[23]	Tenderness at injection site (Majority), tunica albuginea rupture (1)
Jordan[24]	Edema/pain/or ecchymosis (20), No serious AEs
Gelbard et al[25]	Bruising (96), Edema (50), Pain (58), No serious AEs
Gelbard et al[26]	Ecchymosis (441), Edema (30), Pain (250), Corporeal rupture (3), Penile hematoma (3)

AEs: Adverse events.

Table 4 Study outcomes

Ref.	Outcome	Oxford Centre for Evidence-Based
		Medicine 2011 Levels of Evidence
Gelbard et al[22]	Improvement seen in 20 patients (4 had plaque disappearance, 16 had curvature decrease by 20%-100%)	2
Gelbard et al[23]	Overall, 36% responsed to treatment. Improvement greatest in patients with lesser degree of pre-treatment curvature	2
Jordan[24]	Significant mean changes from baseline angular deviation and plaque width at 3, 6, and 9 mo	2
Gelbard et al[25]	Improved penile curvature (29.7% vs 11.0%, P < 0.05 ) and patient reported bother scores for treatment group vs placebo	1
Gelbard et al[26]	Improved penile curvature (34% vs 18%, P < 0.0001) and patient reported symtom bother score for treatment group vs placebo	1