None listed
Conditions
Brief summary
Medications used for male lower urinary tract symptoms are known to cause retrograde ejaculation, however the extent of this is unknown. Quantification of ejaculatory dysfunction and impact on semen quality of medications used for male lower urinary tract symptoms (Silodosin and Alfuzosin) will provide urologists with more accurate and tangible statistics on their impact on ejaculation. Comparisons to placebo will further contextualise results to increase validity and utility of study findings. This will assist in counselling men starting Silodosin or Alfuzosin for lower urinary tract symptoms, to improve patient expectations and understanding, avoid unexpected side effects, and allow patients to make informed decisions in their choice to commence medical therapy for their symptoms. It is hypothesised that both Silodosin and Alfuzosin will result in retrograde ejaculation, demonstrated by a significant deterioration in semen analysis parameters and evidence of semen in urine on urine analysis, to the degree of subfertility, relative to placebo.
Interventions
Each participant will rotate between each of the 3 crossover groups. Treatment in each crossover group will last 30 days. By the end of the study, each participant will have been treated with 30 days of placebo, Silodosin and Alfuzosin. Between crossover, there will be a washout period of 7 days to allow complete clearance of medication from the participant’s systems.
The interventions being studied are Silodosin and Alfuzosin.
This clinical trial involves 3 crossover groups:
1. Silodosin (8mg,
Each participant will rotate between each of the 3 crossover groups. Treatment in each crossover group will last 30 days. By the end of the study, each participant will have been treated with 30 days of placebo, Silodosin and Alfuzosin. Between crossover, there will be a washout period of 7 days to allow complete clearance of medication from the participant’s systems. The interventions being studied are Silodosin and Alfuzosin. This clinical trial involves 3 crossover groups: 1. Silodosin (8mg, oral capsule, daily, in the morning with meal) 2. Alfuzosin (10mg, oral tablet, daily, in the morning, with meal) 3. Placebo (oral microcellulose capsule)
Sponsors
Dr Benjamin Huang - Toowoomba Hospital, Darling Downs Health, Queensland Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria • Adult men (18 years and over) diagnosed Obstructive LUTS to be treated with tamsulosin as part of normal clinical treatment • Normal ejaculatory function prior to starting tamsulosin • Normal erectile function prior to starting tamsulosin
Exclusion criteria
Exclusion criteria • Severe LUTS with post-void residual urine volumes greater than 300ml requiring immediate intervention • Ejaculatory dysfunction prior to starting tamsulosin • Erectile dysfunction prior to starting tamsulosin • Previous exposure to a-1B medications for LUTS • Previous transurethral resection of prostate, bladder neck incision or radical prostatectomy • History of hypertension or obstructive sleep apnoea • History of uncontrolled diabetes (HbA1c >7%) • History of renal impairment (eGFR < 60mL/min/1.73 m²) • Morbid obesity (BMI >40) • Abnormal semen analysis
Outcome results
None listed