Abstract
PD is a connective tissue disorder of the penis resulting in penile deformity and curvature. Consequently, PD patients complain severe impairment of sexual activity and satisfaction, and suffer from detrimental psychological sequelae. Currently, the feasibility and efficacy of CBT-sex as an adjunct short-term intervention for patients undergoing conservative and surgical therapy has not been evaluated. Therefore, there is an urgent need for a pilot study on the feasibility and efficacy of CBT-sex in PD.
Randomized, open, mono-centric feasibility study. PD patients, who are scheduled for either conservative or surgical treatment, are enrolled. Patients are randomized to receive either CBT-sex (CBT+) or no CBT-sex (CBT-), stratified by treatment (conservative or surgical therapy) using block randomization. The CBT+ group receives six CBT-sex sessions (one session per week for 6 weeks) by one certified psychotherapist.
Feasibility of CBT-sex, defined as the percentage of patients randomized to the CBT+ group who fully complete the CBT-sex protocol.
Absolute change from baseline to 20 weeks after randomization in Peyronie's Disease Questionnaire (PDQ) bother score.
Clinical improvement in PDQ bother score at 20 weeks after randomization, defined as a change of at least -2.2 points relative to baseline.
Absolute change from baseline to 20 weeks after randomization in the PDQ psychological and physical symptoms score.
Absolute change from baseline to 20 weeks after randomization in the PDQ penile pain score.
Absolute change from baseline to 20 weeks after randomization in the New Sexual Satisfaction Scale Short-Form (NSSS-SF) score.
Absolute change from baseline to 20 weeks after randomization in the International Index of Erectile Function Erectile Function Domain (IIEF-EF) score.
We present the study protocol of this ongoing study, which will generate first data on CBT-sex to reduce PD-induced stress, symptoms and burdens and to improve the sexual satisfaction and erectile function.
No conflicts of interest.
