Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection (RPLND) in survivors of testicular cancer - Part B
Peter MacCallum Cancer Centre
30 participants
Sep 6, 2022
Interventional
Conditions
Summary
The aim of this study is to investigate the use of pseudoephedrine in patients experiencing retrograde ejaculation following retroperitoneal lymph node dissection for the treatment of testicular cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a confirmed diagnosis of a testicular germ cell tumour, have received retroperitoneal lymph node dissection at least 6 months ago, and have confirmed retrograde ejaculation following the procedure. Study details All participants will complete a one-off series of questionnaires assessing quality of life, and will then receive pseudoephedrine (60mg every 6 hours the day prior to semen collection, followed by an additional 60mg of pseudoephedrine at 0600hrs and 30-60 minutes prior to semen collection) as an oral tablet over a period of 1 day. After 1 day of treatment, participants will undergo semen and post-ejaculatory urine analysis to explore the efficacy of the treatment and any side effects experienced. It is hoped that this study may demonstrate that a short course of pseudoephedrine is effective and safe for the treatment of retrograde ejaculation following retroperitoneal lymph node dissection for the treatment of testicular cancer.
Eligibility
Inclusion Criteria7
- Participants must meet all the following criteria for study entry:
- Participant has provided written, informed consent OR electronic, informed consent sighted by an investigator, on Telehealth.
- Males greater than or equal to 18 years at time of informed consent.
- Histologically confirmed testicular germ cell tumour (based on archival tissue report)
- Retroperitoneal lymph node dissection for management of testicular cancer at least six months prior to consent.
- Confirmed retrograde ejaculation on basis of semen and post-ejaculatory urine analysis, where retroperitoneal lymph node dissection is the likely cause in the opinion of the investigator.
- Participant is willing and able to comply with the protocol for the duration of the study including treatment, and scheduled visits and examination including follow up.
Exclusion Criteria5
- Participants who meet any of the following criteria will be excluded from study entry:
- Currently receiving treatment or planning to receive treatment within two months (i.e., surgery, chemotherapy, radiotherapy) for testicular cancer (or other malignancy).
- Contraindications to pseudoephedrine, including allergy to pseudoephedrine or components, uncontrolled hypertension, poorly controlled diabetes mellitus, seizure disorder, closed angle glaucoma, existing ischaemic heart disease, urinary retention; or other conditions in the opinion of the investigator would pose subject undue risk.
- Currently receiving testosterone replacement therapy (or within last 12 weeks if receiving long-acting preparation).
- Known medical condition or other issue that in the opinion of the investigator, that would affect adherence to study requirements.
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Interventions
PREPARE Part B is a prospective, phase 2, single-arm, open-label study building upon the information gathered in Part A. It will enrol participants with retrograde ejaculation and explore an intervention to help treat the condition. Eligible participants in Part B will receive a short course of pseudoephedrine (60mg every 6 hours for 24 hours administered orally as a tablet, followed by repeat administration at 0600hrs and 30-60 minutes prior to ejaculation) and undergo repeat semen and post-ejaculatory urine analysis to explore the efficacy of this treatment. Participant medication diaries will be completed. After this ~30-hour period, pseudoephedrine is ceased. Additionally, participants in Part B will complete health-related quality of life questionnaires if not performed in Part A and will also be invited to participate in an optional, semi-structured interview.
Locations(1)
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ACTRN12622000542796