Penile Vascular Abnormalities Found in Majority of PFS Patients in Baylor College of Medicine Study

April 28, 2020

Dear Friends:

In a newly published prospective case-control study in Translational Andrology and Urology, Mohit Khera, Director of the Laboratory for Andrology Research at Baylor College of Medicine, and his research team report the presence of vascular abnormalities in the penis of PFS patients (median age of 38) who previously discontinued the use of 5-alpha reductase inhibitors (5ARIs) for hair loss. The penile vascular abnormalities were diagnosed by penile duplex Doppler ultrasound, a laboratory test routinely performed by urologists to evaluate erectile function in older men with benign prostatic hyperplasia (BPH).

“This is the first published report of organic pathology in the penis of PFS patients as evaluated by a common clinical test that objectively evaluates sexual function ,” says PFS Foundation CEO John Santmann. “ These abnormal findings are rarely seen in men in this younger age group. Khera’s findings are particularly meaningful because many physicians frequently dismiss PFS patients’ sexual complaints as having a psychogenic cause.”

“In total, 17 of 25 (68%) of subjects in the 5ARI group had some vascular abnormality on penile Doppler ultrasound,” details Khera. “Eight of twenty-four (32%) patients had arterial insufficiency [defined as peak systolic velocity <25 cm/sec], while 5 of 25 (20%) patients fell into the ‘gray zone’ of possible ED, defined as a peak systolic velocity between 25–35 cm/sec. Four of twenty-four (16%) patients had venous leak, defined as an end diastolic velocity >5 cm/sec.”

The research team also evaluated the effects of finasteride on multiple men’s health parameters. Twenty-five PFS subjects were compared to 28 age-matched controls. All subjects were treated with finasteride while one subject also took dutasteride after quitting finasteride.

Other notable results of the study, which was funded by the PFS Foundation, include:

• The median total International Prostate Symptom Score (IPSS) for PFS patients was 10, compared to 3 for the controls (P<0.01). The PFS group scored significantly worse on questions corresponding to incomplete bladder emptying (P<0.01), frequent urination (P=0.02), weak urine stream (P=0.03), and overall quality of life (P=0.03). These types of genitourinary symptoms are commonly found in older men with BPH.
• According to Khera, results of the Androgen Deficiency in the Aging Male (ADAM) questionnaire “suggest that PFS patients are more likely to have signs and symptoms of hypogonadism.”
• 72% of the PFS patients reported at least one genital complaint, including 60% with some element of genital pain or numbness after starting finasteride.
• Consistent with the results of the Patient Health Questionnaire-9 (PHQ-9), Khera states that the PFS patients experienced “high levels of anhedonia and feelings of hopelessness.”
• Since two of the PFS patients (8%) committed suicide during or after the research period, Khera suggests that “psychiatric side effects and the risks of finasteride use in patients with a history of psychiatric disorders should be investigated further… [P]atients should undergo extensive counseling regarding sexual and nonsexual side effects that may occur after both initiation and discontinuation of this medication class.”

Khera concludes that use of 5ARIs for the treatment of hair loss “may lead to persistent sexual, genitourinary, physical, psycho-cognitive, and anti-androgenic sequelae even after cessation of 5ARI therapy.”

Anyone living in the US who suffers from PFS should report his/her symptoms to the US Food and Drug Administration. Anyone living outside the US who suffers from PFS should report his/her symptoms to the US Food and Drug Administration as well as to his/her national drug-regulatory agency, as directed on our Report Your Side Effects page.