Are patients undergoing intralesional collagenase Clostridium histolyticum injection therapy for Peyronie's disease compliant? A 7-year analysis from a tertiary care men's health center.

Abstract

Background: Peyronie's disease (PD) involves the formation of fibrous scar tissue in the penis, causing pain, deformity, and significant psychological and sexual distress. Intralesional injection of collagenase Clostridium histolyticum (CCH) has emerged as a promising non-surgical treatment, though patients may experience complications and require multiple clinic visits.

Aim: This study aims to evaluate patient compliance with CCH therapy, compare outcomes between compliant and non-compliant groups, and identify reasons for non-compliance.

Methods: This IRB-approved retrospective study analyzed patients with PD between 2017 and 2023. Patients were evaluated by a fellowship-trained andrologist. Patients who elected to have intralesional CCH were initially offered four cycles of treatment, with compliance defined as completing at least four cycles or achieving satisfactory results with fewer cycles.

Outcomes: Data on demographics, disease characteristics, treatment modalities, compliance, and outcomes were extracted from electronic medical records, and causes of non-compliance were identified. Outcomes and complications were compared between compliant and non-compliant groups.

Results: Two hundred and ninety-two PD patients elected to have an intralesional injection of collagenase CCH. Among these, 51.4% completed four treatment cycles, 14.7% received more than four cycles, and 33.9% received fewer than four cycles. The overall compliance rate for injection therapy, including those satisfied with fewer cycles, was 70.89%. Mean pre-treatment curvature for 292 patients was 46.77 ± 14.26 degrees. Compliant patients showed a greater percent of curvature reduction (median 44.44 (IQR 34.17) vs 33.33 (IQR 44.17), P = .034) and less post-treatment curvature in degree (median 25.00 (IQR 17.02) vs 30.00 (IQR 23.75), P = .032) compared to non-compliant patients. Common reasons for incomplete treatment included adverse effects (15.1%), early satisfaction with results (14.1%), and unknown factors (45.4%).

Clinical implications: Compliance with CCH therapy for PD significantly impacts treatment outcomes. Healthcare providers should address factors contributing to non-compliance. Qualitative studies are recommended to gain deeper insights into non-compliant patients.

Strengths and limitations: This study analyzed compliance in a large cohort of PD patients and compared outcomes between compliant and non-compliant groups. However, missing data in the non-compliant group and the bias between compliant and non-compliant patients in this retrospective study are major notable limitations.

Conclusion: Overall compliance rate for CCH injection therapy was 70.89%. Greater curvature reduction was demonstrated in compliant patients. Common reasons for incomplete treatment included adverse effects (15.1%), early satisfaction with results (14.1%), and unknown factors (45.4%). However, missing data and bias from retrospective design are major limitations.