Intralesional collagenase Clostridium histolyticum vs. verapamil injections in males with Peyronie's Disease: A prospective, matched-pair, non-blinded, randomised clinical study comparing clinical outcomes and patient satisfaction rates.

2022-09-01
Investigative and clinical urology 63(5)
- Eric Chung
- Juan Wang

PubMed: 36068002
DOI: 10.4111/icu.20220145

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 50
Population: males with Peyronie's disease (PD)
Methods: Prospective open-label non-blinded study; patients randomised to receive ILV or CCH injections with penile remodelling every fortnightly for 6 courses
Blinding: Open-label
Duration: 24-month post-treatment
Funding: Unclear

Purpose

To compare clinical outcomes and patient satisfaction rates between intralesional verapamil (ILV) and collagenase Clostridium histolyticum (CCH) injections in males with Peyronie's disease (PD).

Materials and methods

Following ethics approval, PD patients were prospectively enrolled in this open-label non-blinded study. Patients were randomised to receive ILV or CCH injections with penile remodelling every fortnightly for 6 courses. Patient demographics, change in penile curvature, International Index of Erectile Function-15 and Peyronie's Disease Questionnaire (PDQ) scores as well as overall patient satisfaction and Patient Global Impression of Improvement (PGI-I) scores were recorded at pre-treatment and 6-, 12- and 24-month post-treatment.

Results

A total of 50 males were recruited and divided into ILV (n=25) and CCH (n=25) groups. The mean changes in penile curvature were -16.8 (standard deviation [SD] 7.65) degrees in ILV and -28.2 (SD 11.5) degrees in CCH groups (p<0.01). Patients in the CCH group scored better than the ILV group on the PDQ psychosexual symptoms (-2.14 vs. -2.9; p<0.01) and symptom bother score (-3.88 vs. -4.16; p=0.08). Minor treatment-related adverse events were more common in the CCH group. The overall satisfaction rate on a 5-point scale was 4.1 in ILV and 4.5 in CCH groups, and there was no statistically significant difference in the PGI-I scores between the 2 groups (p=0.14).

Conclusions

CCH therapy is more effective than ILV to treat a carefully selected group of males with PD, with a reasonable safety profile and a higher high level of patient satisfaction rate in the short term.