Trial in progress: PREPARE-Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection (RPLND) in survivors of testicular cancer (TC).

TPS432 Background: Retrograde ejaculation is a known complication of RPLND occurring due to interruption of sympathetic nerve fibres intraoperatively. Whilst common immediately after surgery, the prevalence of persistent symptoms, and impact on health-related quality-of-life (HRQoL) in TC survivors is unknown. Whilst few effective treatments are available, alpha-sympathomimetics such as pseudoephedrine may form a viable treatment option due to effects on bladder neck constriction at sexual climax propagating antegrade ejaculation. Existing studies have shown pseudoephedrine may be helpful in individuals with retrograde ejaculation; however, these studies have only included a small number (n=5) of patients following RPLND. Methods: In a two-part, single-arm phase 2 clinical trial, participants with a history of TC receiving follow-up after RPLND at least >6 months prior will be invited to participate. In part A (ACTRN12622000537752), eligible participants complete questionnaires regarding survivorship issues including sexual function and fertility to explore the prevalence of retrograde ejaculation and HRQoL. Questionnaires include EORTC QLQ-C30, sexual function items from EORTC QLQ-TC26, Brief Male Sexual Function Inventory and tailored questions focusing on retrograde ejaculation. 15 out of a planned 50 participants (30%) have been enrolled and completed questionnaires. If retrograde ejaculation is reported, eligible participants are invited to enrol in Part B (ACTRN12622000542796), where if the participant has no contraindications to pseudoephedrine, nor are they receiving testosterone replacement and retrograde ejaculation is confirmed during screening, they receive a short course of pseudoephedrine hydrochloride. Pseudoephedrine will be given 60mg QID for one-day, followed by 60mg 4 hours and 1 hour prior to ejaculation to evaluate changes in ejaculation volume, sperm count within (any) antegrade ejaculate and within the post-ejaculatory urine. The primary endpoint is total sperm count in antegrade ejaculate of at least 39 million (5th centile) following treatment. We assumed that pseudoephedrine is ineffective if <10% of participants achieve a normal sperm count in antegrade ejaculate after treatment. Using an exact binomial power analysis for a one-sample proportion test, a sample size of 25 participants provides >80% power to detect 36% (9 out of 25) of participants achieving a normal sperm count against a reference proportion of 10% at the 0.05 significance level. 4 out of a planned 30 participants (16%) have been enrolled. All participants with retrograde ejaculation will be invited to an optional, semi-structured interview to further evaluate impact(s) of retrograde ejaculation on issues around sexual health, relationships, body image and masculinity. Clinical trial information: ACTRN12622000537752 , ACTRN12622000542796 .