PD26-04: ACCEPTANCE AND COMMITMENT THERAPY TO INCREASE COMPLIANCE WITH INTRACAVERNOSAL INJECTION USE (ICI) FOLLOWING RADICAL PROSTATECTOMY (RP): PRELIMINARY RESULTS FROM A RANDOMIZED CONTROL TRIAL

Christian Nelson, Rebecca Tutino, Hayley Pessin, Nisha Joshi, John P. Mulhall

Introduction: ICI is the cornerstone of many erectile rehabilitation programs (ERP). However, compliance with ICI is historically low. This study tests a novel psychological intervention based on Acceptance and Commitment Therapy (ACT) concepts to help men reduce avoidance to ICI and commit to an ERP.

Methods: This ongoing study recruits men starting in our ERP. The recruitment goal is N=220. Subjects are randomized to ERP+ACT or ERP+Enhanced Monitoring and Education (EME).  ERP+ACT receive ERP plus 3 ACT Sessions (30-45min) and 10 ACT Booster Sessions (10min). ERP+EME receive ERP plus 3 EME Sessions (30-45min) and 10 EME Booster Sessions (10min) delivered by a nurse practitioner monitoring ICI use and providing education. The interventions are delivered over 1yr.  Eligibility includes: within 9m post RP; functional pre-RP erections (=6/10). Subjects are assessed at entry and every 6m for 2yrs. Primary outcomes: # of penile injections/wk (verified by syringe count), and compliance (defined as =2 injections/wk). Secondary outcomes: ED treatment satisfaction, sexual self-esteem and relationship quality, sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Preliminary 6m data is presented. Groups are compared with ANCOVA. Since these are preliminary analyses, if differences were not statistically significant, effect sizes (d) are reported (d=0.2, small effect; d=0.5, medium effect; d=0.8, large effect).

Results: To date, 120 subjects have been randomized; 62 have completed the 6m assessment (ACT n=33, EME n=29). Mean age 60±7 yrs and 81% were married. The mean erectile function grade pre-RP was 9±1 (0-10 scale). At 6m, the ACT group utilized more injections/wk vs. the EM group (1.8 vs. 1.4, p=0.01, d=0.7) and were more compliant with ICI vs. the EM group (70% vs. 45%, p=0.05, RR=1.55).  The ACT group reported greater: satisfaction with ED treatment (d=0.6) and overall sexual relationship (d=0.2). The ACT group also reported lower: sexual bother (d=0.2), prostate cancer treatment regret (d=0.3), negative psychological impact of cancer (d=0.3), and depressive symptoms (d=0.2).

Conclusions: Preliminary analysis suggests ACT significantly increases ICI use.  Data also indicate ACT helps increase men’s satisfaction with injections and sexual relationship, while reducing sexual bother, prostate cancer treatment regret, the psychological impact of cancer, and depressive symptoms. Source of

Funding: NIH: R01 CA 190636