Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection (RPLND) in survivors of testicular cancer - Part B

Phase 2

Completed

• Conditions: Testicular cancer; Retrograde ejaculation; Retroperitoneal node dissection; Cancer - Testicular; Surgery - Other surgery; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12622000542796
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-06
• Study Completion: 2023-09-05
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Participants must meet all the following criteria for study entry:
1.Participant has provided written, informed consent OR electronic, informed consent sighted by an investigator, on Telehealth.
2.Males greater than or equal to 18 years at time of informed consent.
3.Histologically confirmed testicular germ cell tumour (based on archival tissue report)
4.Retroperitoneal lymph node dissection for management of testicular cancer at least six months prior to consent.
5.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.
6.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 Criteria

Participants who meet any of the following criteria will be excluded from study entry:
1.Currently receiving treatment or planning to receive treatment within two months (i.e., surgery, chemotherapy, radiotherapy) for testicular cancer (or other malignancy).
2.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.
3.Currently receiving testosterone replacement therapy (or within last 12 weeks if receiving long-acting preparation).
4.Known medical condition or other issue that in the opinion of the investigator, that would affect adherence to study requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with total sperm count of antegrade ejaculate of at least 39 million (5th centile) using semen analysis following treatment with pseudoephedrine.[ 1 day post-pseudoephedrine commencement]